Clinical trial NCT02365636: A Study to Evaluate the Safety and Efficacy of Topically Applied TV 45070 Ointment in Patients With Postherpetic Neuralgia (PHN)
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (4% and 8% w/w Ointment) in Patients With Postherpetic Neuralgia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the safety and efficacy of 4% and 8% w/w TV 45070 ointment compared with placebo ointment applied topically and twice daily to the area of PHN pain for 4 weeks in patients with PHN


Eligibility criteria: Inclusion Criteria:

* Patient has chronic Postherpetic Neuralgia (PHN), defined as pain present for more than 6 months and less than 10 years after onset of herpes zoster skin rash affecting a single dermatome. Patients with more than 1 involved dermatome may also be included, provided the affected dermatomes are contiguous.
* Patient is ≥18 years of age, with a body mass index (BMI) between 18 and 34 kg/m2, inclusive, at the screening visit.
* If the patient is a woman and is fertile, the patient is not pregnant and has negative pregnancy tests at both the screening and randomization visits, and agrees to use an acceptable method of contraception for the duration of the study, including follow-up.
* If the patient is a man and is capable of producing offspring, the patient must agree to use an acceptable method of contraception, unless the partner cannot become pregnant for the duration of the study, including follow-up.
* Patient must sign the written Informed Consent Form (ICF) for the study and be willing to comply with all study procedures and restrictions.
* Patient must be judged by the investigator to be medically healthy (except for PHN) and able to participate in the study

  * Other criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Patient has any other severe pain that might confound assessment or self-evaluation of pain due to PHN.
* Patient has PHN affecting the face (trigeminal nerve distribution).
* Patient has a history, in the judgment of the investigator, of inadequate response to more than 3 adequate courses of treatment with other medications used to treat neuropathic pain (eg, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, anticonvulsants, topical lidocaine, and/or topical capsaicin).
* Patient is taking oral analgesics (either opioid or non-opioid) or is receiving topical therapy such as the 5% topical lidocaine patch for the treatment of pain and is unwilling or unable to complete a washout period during which the patient will discontinue analgesic therapy or topical pain therapy.
* Patient has been treated with topical capsaicin at any time in the past 6 months for neuropathic pain.
* Patient has a history of fibromyalgia.

  * Other criteria apply, please contact the investigator for more information

Primary outcomes:
measure: Change From Baseline to Week 4 in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores Using a Mixed Model for Repeated Measures
timeFrame: Baseline (day -7 to day -1), Week 4 (day 22 to day 28)
Secondary outcomes:
measure: Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures
timeFrame: Baseline (day -7 to day -1), Week 4 (day 22 to day 28)
measure: Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Morning Using a Mixed Model for Repeated Measures
timeFrame: Baseline (day -7 to day -1), Week 4 (day 22 to day 28)
measure: Change From Baseline to Week 4 in the Weekly Average of the Worst Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures
timeFrame: Baseline (day -7 to day -1), Week 4 (day 22 to day 28)
measure: Percentage of Participants With >=30% and >=50% Improvement From Baseline in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores at Week 4 Using a Mixed Model for Repeated Measures
timeFrame: Baseline (day -7 to day -1), Week 4 (day 22 to day 28)
measure: Change From Baseline to Weeks 2 and 4 in the Neuropathic Pain Symptom Inventory (NPSI) Total Score Using a Mixed Model for Repeated Measures (MMRM)
timeFrame: Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29)
measure: Change From Baseline to Week 4 in the Neuropathic Pain Impact on Quality of Life (NePIQoL) Total Score
timeFrame: Baseline (day 1), Week 4 (day 29)
measure: Participants' Global Assess of Treatment as Measured by the Patient Global Impression of Change (PGIC) at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM)
timeFrame: Weeks 2 (day 15) and Week 4 (day 29)
measure: Change From Baseline to Weeks 2 and 4 in the Daily Sleep Interference Scale (DSIS) Using a Mixed Model for Repeated Measures
timeFrame: Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29)
measure: Kaplan-Meier Estimates for First Time to Reach 30% or More Sustained Improvement in Weekly Average of the Daily Average NRS Pain Scores
timeFrame: Baseline (days -7 to -1), Week 1 (days 1-7), Week 2 (day 8-14), Week 3 (days 15-21), Week 4 (days 22-29)
measure: Change From Baseline to Weeks 2 and 4 in Maximal Intensity of Brush-Evoked Allodynia as Measured on an 11-point Numeric Rating Scale (NRS) Using a Mixed Model for Repeated Measures (MMRM)
timeFrame: Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29)
measure: Change From Baseline to Weeks 2 and 4 in Maximal Intensity of Punctate-Evoked Hyperalgesia as Measured on an 11-point Numeric Rating Scale (NRS) Using a Mixed Model for Repeated Measures (MMRM)
timeFrame: Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29)
measure: Participants With Treatment-Emergent Adverse Events
timeFrame: day 1 up to day 57
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Teva Investigational Site 13052
state: Alabama
city: Mobile
country: United States
facility: Teva Investigational Site 13086
state: Alabama
city: Phoenix
country: United States
facility: Teva Investigational Site 13514
state: Arizona
city: Phoenix
country: United States
facility: Teva Investigational Site 13520
state: Arizona
city: Little Rock
country: United States
facility: Teva Investigational Site 13661
state: Arkansas
city: Colton
country: United States
facility: Teva Investigational Site 13079
state: California
city: Pomona
country: United States
facility: Teva Investigational Site 13331
state: California
city: Sacramento
country: United States
facility: Teva Investigational Site 13341
state: California
city: Santa Monica
country: United States
facility: Teva Investigational Site 13051
state: California
city: Thousand Oaks
country: United States
facility: Teva Investigational Site 13055
state: California
city: Torrance
country: United States
facility: Teva Investigational Site 13100
state: California
city: Milford
country: United States
facility: Teva Investigational Site 13657
state: Connecticut
city: Brandon
country: United States
facility: Teva Investigational Site 13521
state: Florida
city: Brooksville
country: United States
facility: Teva Investigational Site 13085
state: Florida
city: Clearwater
country: United States
facility: Teva Investigational Site 13057
state: Florida
city: Fort Myers
country: United States
facility: Teva Investigational Site 13084
state: Florida
city: Hialeah
country: United States
facility: Teva Investigational Site 13047
state: Florida
city: Homestead
country: United States
facility: Teva Investigational Site 13046
state: Florida
city: Jacksonville
country: United States
facility: Teva Investigational Site 13098
state: Florida
city: Kissimmee
country: United States
facility: Teva Investigational Site 13045
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13064
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13338
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13044
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13335
state: Florida
city: Naples
country: United States
facility: Teva Investigational Site 13522
state: Florida
city: New Port Richey
country: United States
facility: Teva Investigational Site 13058
state: Florida
city: Oldsmar
country: United States
facility: Teva Investigational Site 13076
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 13073
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 13048
state: Florida
city: Pembroke Pines
country: United States
facility: Teva Investigational Site 13659
state: Florida
city: Saint Petersburg
country: United States
facility: Teva Investigational Site 13056
state: Florida
city: Seminole
country: United States
facility: Teva Investigational Site 13519
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 13059
state: Florida
city: Venice
country: United States
facility: Teva Investigational Site 13329
state: Florida
city: Virginia Gardens
country: United States
facility: Teva Investigational Site 13513
state: Florida
city: Atlanta
country: United States
facility: Teva Investigational Site 13053
state: Georgia
city: Marietta
country: United States
facility: Teva Investigational Site 13063
state: Georgia
city: Aurora
country: United States
facility: Teva Investigational Site 13091
state: Illinois
city: Bolingbrook
country: United States
facility: Teva Investigational Site 13072
state: Illinois
city: Evansville
country: United States
facility: Teva Investigational Site 13062
state: Indiana
city: Evansville
country: United States
facility: Teva Investigational Site 13093
state: Indiana
city: Monroe
country: United States
facility: Teva Investigational Site 13074
state: Louisiana
city: Shreveport
country: United States
facility: Teva Investigational Site 13660
state: Louisiana
city: Brockton
country: United States
facility: Teva Investigational Site 13094
state: Massachusetts
city: Detroit
country: United States
facility: Teva Investigational Site 13061
state: Michigan
city: Farmington Hills
country: United States
facility: Teva Investigational Site 13049
state: Michigan
city: Saint Louis
country: United States
facility: Teva Investigational Site 13099
state: Missouri
city: Las Vegas
country: United States
facility: Teva Investigational Site 13065
state: Nevada
city: Albuquerque
country: United States
facility: Teva Investigational Site 13066
state: New Mexico
city: Albuquerque
country: United States
facility: Teva Investigational Site 13330
state: New Mexico
city: Albany
country: United States
facility: Teva Investigational Site 13658
state: New York
city: Brooklyn
country: United States
facility: Teva Investigational Site 13334
state: New York
city: New York
country: United States
facility: Teva Investigational Site 13054
state: New York
city: North Massapequa
country: United States
facility: Teva Investigational Site 13083
state: New York
city: Calabash
country: United States
facility: Teva Investigational Site 13060
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 13337
state: North Carolina
city: Winston-Salem
country: United States
facility: Teva Investigational Site 13082
state: North Carolina
city: Columbus
country: United States
facility: Teva Investigational Site 13089
state: Ohio
city: Oklahoma City
country: United States
facility: Teva Investigational Site 13075
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 13328
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 13516
state: Oklahoma
city: Eugene
country: United States
facility: Teva Investigational Site 13078
state: Oregon
city: Levittown
country: United States
facility: Teva Investigational Site 13333
state: Pennsylvania
city: Philadelphia
country: United States
facility: Teva Investigational Site 13339
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Investigational Site 13327
state: Pennsylvania
city: Charleston
country: United States
facility: Teva Investigational Site 13332
state: South Carolina
city: Rapid City
country: United States
facility: Teva Investigational Site 13068
state: South Dakota
city: Knoxville
country: United States
facility: Teva Investigational Site 13095
state: Tennessee
city: Memphis
country: United States
facility: Teva Investigational Site 13096
state: Tennessee
city: Arlington
country: United States
facility: Teva Investigational Site 13070
state: Texas
city: Austin
country: United States
facility: Teva Investigational Site 13088
state: Texas
city: McKinney
country: United States
facility: Teva Investigational Site 13340
state: Texas
city: Plano
country: United States
facility: Teva Investigational Site 13050
state: Texas
city: Salt Lake City
country: United States
facility: Teva Investigational Site 13518
state: Utah
city: Norfolk
country: United States
facility: Teva Investigational Site 13090
state: Virginia
city: Bellevue
country: United States
facility: Teva Investigational Site 13081
state: Washington
city: Seattle
country: United States
facility: Teva Investigational Site 13336
state: Washington
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: