Clinical trial NCT00538850: Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
Official title: A Randomized, Double-blind, Placebo-controlled Multi-center Study to Evaluate the Safety and Efficacy of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Keywords: unspecified adult solid tumor, protocol specific
pain
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
stage IV chronic lymphocytic leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II small lymphocytic lymphoma
noncontiguous stage II marginal zone lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III small lymphocytic lymphoma
stage III marginal zone lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent small lymphocytic lymphoma
recurrent marginal zone lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent mycosis fungoides/Sezary syndrome
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
de novo myelodysplastic syndromes
myelodysplastic/myeloproliferative neoplasm, unclassifiable
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
atypical chronic myeloid leukemia, BCR-ABL1 negative
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
contiguous stage II adult Burkitt lymphoma
stage I adult Burkitt lymphoma
contiguous stage II adult diffuse large cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II small lymphocytic lymphoma
contiguous stage II marginal zone lymphoma
stage I adult diffuse large cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage I adult diffuse small cleaved cell lymphoma
stage I small lymphocytic lymphoma
stage I marginal zone lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
contiguous stage II mantle cell lymphoma
stage I mantle cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
stage I adult immunoblastic large cell lymphoma
contiguous stage II adult lymphoblastic lymphoma
stage I adult lymphoblastic lymphoma
refractory multiple myeloma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
recurrent adult T-cell leukemia/lymphoma
stage I adult T-cell leukemia/lymphoma
stage II adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
chronic eosinophilic leukemia
primary myelofibrosis
chronic neutrophilic leukemia
essential thrombocythemia
polycythemia vera
relapsing chronic myelogenous leukemia
T-cell large granular lymphocyte leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
secondary acute myeloid leukemia
acute undifferentiated leukemia
refractory chronic lymphocytic leukemia
stage 0 chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
refractory hairy cell leukemia
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
recurrent adult grade III lymphomatoid granulomatosis
Waldenström macroglobulinemia
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
post-transplant lymphoproliferative disorder
extramedullary plasmacytoma
isolated plasmacytoma of bone
monoclonal gammopathy of undetermined significance
primary systemic amyloidosis
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult grade III lymphomatoid granulomatosis
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma
intraocular lymphoma
meningeal chronic myelogenous leukemia
primary central nervous system non-Hodgkin lymphoma
primary central nervous system Hodgkin lymphoma
stage I adult Hodgkin lymphoma
recurrent squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage I squamous cell carcinoma of the larynx
stage I verrucous carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage II verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
recurrent adenoid cystic carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent verrucous carcinoma of the oral cavity
stage I adenoid cystic carcinoma of the oral cavity
stage I mucoepidermoid carcinoma of the oral cavity
stage I verrucous carcinoma of the oral cavity
stage II adenoid cystic carcinoma of the oral cavity
stage II mucoepidermoid carcinoma of the oral cavity
stage II verrucous carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage III verrucous carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV verrucous carcinoma of the oral cavity
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent basal cell carcinoma of the lip
recurrent squamous cell carcinoma of the lip and oral cavity
stage I basal cell carcinoma of the lip
stage II basal cell carcinoma of the lip
stage III basal cell carcinoma of the lip
stage IV basal cell carcinoma of the lip
metastatic squamous neck cancer with occult primary squamous cell carcinoma
recurrent metastatic squamous neck cancer with occult primary
untreated metastatic squamous neck cancer with occult primary
recurrent lymphoepithelioma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage I lymphoepithelioma of the nasopharynx
stage I squamous cell carcinoma of the nasopharynx
stage II lymphoepithelioma of the nasopharynx
stage II squamous cell carcinoma of the nasopharynx
stage III lymphoepithelioma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent lymphoepithelioma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage I lymphoepithelioma of the oropharynx
stage I squamous cell carcinoma of the oropharynx
stage II lymphoepithelioma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III lymphoepithelioma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV lymphoepithelioma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage I inverted papilloma of the paranasal sinus and nasal cavity
stage I midline lethal granuloma of the paranasal sinus and nasal cavity
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage II inverted papilloma of the paranasal sinus and nasal cavity
stage II midline lethal granuloma of the paranasal sinus and nasal cavity
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage III inverted papilloma of the paranasal sinus and nasal cavity
stage III midline lethal granuloma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage IV inverted papilloma of the paranasal sinus and nasal cavity
stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
high-grade salivary gland mucoepidermoid carcinoma
low-grade salivary gland mucoepidermoid carcinoma
recurrent salivary gland cancer
salivary gland acinic cell tumor
salivary gland adenocarcinoma
salivary gland adenoid cystic carcinoma
salivary gland anaplastic carcinoma
salivary gland malignant mixed cell type tumor
salivary gland poorly differentiated carcinoma
salivary gland squamous cell carcinoma
stage I salivary gland cancer
stage II salivary gland cancer
stage III salivary gland cancer
stage IV salivary gland cancer
adult grade I meningioma
adult choroid plexus tumor
adult craniopharyngioma
adult myxopapillary ependymoma
adult diffuse astrocytoma
adult pilocytic astrocytoma
adult pineocytoma
adult ependymoma
adult subependymoma
adult oligodendroglioma
adult subependymal giant cell astrocytoma
meningeal melanocytoma
adult meningeal hemangiopericytoma
adult pineal gland astrocytoma
adult central nervous system germ cell tumor
adult medulloblastoma
adult supratentorial primitive neuroectodermal tumor (PNET)
adult ependymoblastoma
adult anaplastic astrocytoma
adult anaplastic ependymoma
adult glioblastoma
adult gliosarcoma
adult giant cell glioblastoma
adult grade III meningioma
adult anaplastic oligodendroglioma
adult pineoblastoma
adult mixed glioma
recurrent adult brain tumor
adult anaplastic meningioma
adult papillary meningioma
adult brain stem glioma
stage IA cervical cancer
stage IB cervical cancer
stage IIA cervical cancer
stage IIB cervical cancer
stage III cervical cancer
stage IVA cervical cancer
stage IVB cervical cancer
recurrent cervical cancer
recurrent endometrial carcinoma
stage I endometrial carcinoma
stage II endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma
fallopian tube cancer
recurrent ovarian epithelial cancer
recurrent ovarian germ cell tumor
stage I ovarian epithelial cancer
stage I ovarian germ cell tumor
stage II ovarian epithelial cancer
stage II ovarian germ cell tumor
stage III ovarian epithelial cancer
stage III ovarian germ cell tumor
stage IV ovarian epithelial cancer
stage IV ovarian germ cell tumor
ovarian sarcoma
ovarian stromal cancer
recurrent uterine sarcoma
stage I uterine sarcoma
stage II uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
recurrent colon cancer
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
recurrent bladder cancer
recurrent gallbladder cancer
stage I bladder cancer
stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer
recurrent gastric cancer
stage I gastric cancer
stage II gastric cancer
stage III gastric cancer
stage IV gastric cancer
advanced adult primary liver cancer
recurrent small intestine cancer
localized transitional cell cancer of the renal pelvis and ureter
metastatic transitional cell cancer of the renal pelvis and ureter
recurrent renal cell cancer
recurrent transitional cell cancer of the renal pelvis and ureter
regional transitional cell cancer of the renal pelvis and ureter
stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer
distal urethral cancer
proximal urethral cancer
recurrent urethral cancer
urethral cancer associated with invasive bladder cancer
stage I adrenocortical carcinoma
stage II adrenocortical carcinoma
stage III adrenocortical carcinoma
stage IV adrenocortical carcinoma
recurrent adrenocortical carcinoma
extragonadal germ cell tumor
localized gastrointestinal carcinoid tumor
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
regional gastrointestinal carcinoid tumor
gastrinoma
insulinoma
WDHA syndrome
glucagonoma
pancreatic polypeptide tumor
somatostatinoma
recurrent islet cell carcinoma
carcinoma of the appendix
localized extrahepatic bile duct cancer
recurrent extrahepatic bile duct cancer
unresectable extrahepatic bile duct cancer
localized gallbladder cancer
unresectable gallbladder cancer
gastrointestinal stromal tumor
localized resectable adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
recurrent pancreatic cancer
small intestine adenocarcinoma
small intestine leiomyosarcoma
small intestine lymphoma
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
pulmonary carcinoid tumor
extensive stage small cell lung cancer
limited stage small cell lung cancer
recurrent small cell lung cancer
liver metastases
lung metastases
primary peritoneal cavity cancer
lung papilloma
peripheral primitive neuroectodermal tumor of the kidney
clear cell sarcoma of the kidney
rhabdoid tumor of the kidney
congenital mesoblastic nephroma
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent breast cancer
male breast cancer
breast cancer in situ
localized osteosarcoma
metastatic osteosarcoma
recurrent osteosarcoma
localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
chondrosarcoma
malignant giant cell tumor of bone
desmoid tumor
stage I adult soft tissue sarcoma
stage II adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
recurrent thymoma and thymic carcinoma
advanced malignant mesothelioma
localized malignant mesothelioma
recurrent malignant mesothelioma
phosphaturic mesenchymal tumor
stage I malignant testicular germ cell tumor
stage II malignant testicular germ cell tumor
stage III malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
stage 0 penile cancer
stage I penile cancer
stage II penile cancer
stage III penile cancer
stage IV penile cancer
recurrent penile cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer
stage 0 vaginal cancer
stage I vaginal cancer
stage II vaginal cancer
stage III vaginal cancer
stage IVA vaginal cancer
stage IVB vaginal cancer
recurrent vaginal cancer
stage 0 vulvar cancer
stage I vulvar cancer
stage II vulvar cancer
stage III vulvar cancer
stage IVB vulvar cancer
recurrent vulvar cancer
stage 0 anal cancer
stage I anal cancer
stage II anal cancer
stage IIIA anal cancer
stage IIIB anal cancer
stage IV anal cancer
recurrent anal cancer
stage 0 rectal cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer
recurrent rectal cancer
stage 0 esophageal cancer
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
recurrent esophageal cancer
stage I thymoma
stage II thymoma
stage III thymoma
stage IVA thymoma
stage IVB thymoma
recurrent melanoma
stage 0 melanoma
stage IA melanoma
stage IB melanoma
stage IIA melanoma
stage IIB melanoma
stage IIC melanoma
stage IIIA melanoma
stage IIIB melanoma
stage IIIC melanoma
stage IV melanoma
Lead sponsor: INSYS Therapeutics Inc
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-10-03
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain. The study medication is administered under the tongue as a simple spray and can be self-administered by patients or assisted by their caregivers. Patients are titrated to an effective-dose of fentanyl sublingual spray in the open-label titration period and then proceed to the double-blind randomized period where they randomly receive 7 treatments with fentanyl sublingual spray and 3 treatments with placebo. Patients are treated for up to a total of 6-7 weeks (including both the open-label titration and the double-blind randomized periods).

Detailed description: RATIONALE

Fentanyl sublingual spray may help relieve breakthrough pain in patients receiving opioids for cancer pain.

OBJECTIVES

Primary

* Determine the efficacy and safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain in patients on around-the-clock opioids for their persistent cancer pain.

Secondary

* Evaluate the safety of fentanyl sublingual spray in these opioid-tolerant patients.
* Assess the patient's satisfaction with treatment medication.

Eligibility criteria: Inclusion Criteria:

* Male or female, ≥ 18 years of age.
* Diagnosis of cancer.
* Opioid-tolerant. Subjects who were opioid tolerant were those taking ≥ 60 mg of oral morphine/day, at least 25 μg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer for cancer-related pain.
* Experienced persistent pain related to the cancer or its treatment of moderate or lesser intensity in the 24 hours prior to assessment by a verbal rating scale at the Screening Visit.
* Over the previous 7 days, subject experienced, on average, 1 to 4 breakthrough cancer pain episodes per day usually at least partially controlled by supplemental medication of at least 5 mg immediate-release morphine or an equivalent short-acting opioid (eg, oxycodone, hydrocodone, or codeine with acetaminophen).
* Able to evaluate and record pain relief, assess medication performance at set times after dosing, record AEs, record each use of the study drug or supplemental medication in an electronic diary (a caregiver may have provided the subject the medication, help with the mechanics of handling the electronic diary but was not permitted to record any information in the electronic diary).
* Able and willing to give informed consent.
* Women of childbearing potential were to have a) a negative serum pregnancy test, b) not be breastfeeding and c) agree to practice a reliable form of contraception.

Exclusion Criteria:

* Intolerance to opioids or fentanyl.
* Current use of commercially available oral short-acting fentanyl for breakthrough pain. Subjects previously on Actiq or Fentora were permitted to be enrolled if they had a 7 day washout.
* Rapidly increasing/uncontrolled pain.
* A history of major organ system impairment or disease, that in the Investigator's or his/her designee's opinion could increase the risk associated with the use of opioids.
* Uncontrolled hypertension (systolic blood pressure {SBP} \> 180 mmHg or diastolic blood pressure \[DBP\] \> 90 mmHg on 2 occasions ≥ 6 hours apart) despite antihypertensive therapy, or a history of hypertensive crisis within the past 2 years.
* A recent history (≤ 2 years prior) of transient ischemic attacks, neural vascular disease, stroke, or cerebral aneurysms.
* Clinically uncontrolled sleep apnea.
* Brain metastases with signs or symptoms of increased intracranial pressure.
* Inability to assess pain or response to pain medications for any reason, including psychiatric disorder, concurrent medical disorder, or concomitant therapy.
* Received investigational study product(s) ≤ 30 days prior to the Screening Visit.
* Painful erythema, oedema or ulcers under the tongue.
* Use of monoamine oxidase (MAO) inhibitors within 14 days of the Screening Visit.

Primary outcomes:
measure: Summed Pain Intensity Differences (SPID) at 30 Minutes After Dosing (SPID30)
timeFrame: Baseline (time 0, beginning of each pain episode) through 30 minutes after dosing for each pain episode
Secondary outcomes:
measure: Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing
timeFrame: Baseline (time 0, beginning of each pain episode) through 60 minutes after dosing for each pain episode
measure: Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing
timeFrame: 5 through 60 minutes after dosing for each pain episode
measure: Global Evaluation of the Study Medication at 30 and 60 Minutes After Dosing
timeFrame: 30 through 60 minutes after dosing for each pain episode
Other outcomes:
Locations:
city: Chandler
country: United States
facility: InSys Therapeutics, Incorporated
state: Arizona
Study officials:
affiliation: INSYS Therapeutics Inc
name: Larry Dillaha, MD
role: STUDY_CHAIR
References:
citation: Rauck R, Reynolds L, Geach J, Bull J, Stearns L, Scherlis M, Parikh N, Dillaha L. Efficacy and safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin. 2012 May;28(5):859-70. doi: 10.1185/03007995.2012.683111. Epub 2012 May 2.
citation: Alberts DS, Smith CC, Parikh N, Rauck RL. Fentanyl sublingual spray for breakthrough cancer pain in patients receiving transdermal fentanyl. Pain Manag. 2016 Oct;6(5):427-34. doi: 10.2217/pmt-2015-0009. Epub 2016 Mar 29.