Clinical trial NCT01462435: Study of Diclofenac Capsules to Treat Pain Following Bunionectomy
Official title: A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Diclofenac [Test] Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Other Acute Postoperative Pain
Lead sponsor: Iroko Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2011-10-31
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of bunionectomy pain.


Eligibility criteria: Inclusion Criteria:

* Patient is male or female between 18 and 65 years of age
* For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
* Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
* Patient must be willing to stay at the study site ≥ 72 hours

Exclusion Criteria:

* Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
* Patient has a current disease or history of a disease that will impact the study or the patient's well-being
* Patient has used or intends to use any of the medications that are prohibited by the protocol
* Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
* Patient has taken another investigational drug within 30 days prior to screening

Primary outcomes:
measure: The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48), ANCOVA Model.
timeFrame: 0 - 48 hours
Secondary outcomes:
measure: VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.
timeFrame: 0 - 4 hours
measure: VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.
timeFrame: 0 - 8 hours
measure: VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry.
timeFrame: 0 - 24 hours
measure: Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.
timeFrame: 0 - 4 hours
measure: TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours
timeFrame: 0 - 8 hours
measure: TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours
timeFrame: 0 - 24 hours
measure: TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours
timeFrame: 0 - 48 hours
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Premier Research Group Limited
state: Arizona
city: Pasadena
country: United States
facility: Chesapeake Research Group, LLC
state: Maryland
city: Austin
country: United States
facility: Premier Research Group Limited
state: Texas
city: Salt Lake City
country: United States
facility: Premier Research Group Limited
state: Utah
Study officials:
affiliation: Premier Research Group Limited
name: Michael Golf, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Chesapeake Research Group, LLC
name: Ira Gottlieb, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Premier Research Group Limited
name: Kyle Patrick, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Premier Research Group Limited
name: S. Thomas Schiffgen, DPM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Argoff C, McCarberg B, Gudin J, Nalamachu S, Young C. SoluMatrix(R) Diclofenac: Sustained Opioid-Sparing Effects in a Phase 3 Study in Patients with Postoperative Pain. Pain Med. 2016 Oct;17(10):1933-1941. doi: 10.1093/pm/pnw012. Epub 2016 Mar 19.