Study to Assess the Efficacy, Safety, and Tolerability of ADL5747 in Participants With Postherpetic Neuralgia
|ClinicalTrials.gov Identifier: NCT01058642|
Recruitment Status : Terminated
First Posted : January 29, 2010
Results First Posted : July 8, 2015
Last Update Posted : July 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Postherpetic Neuralgia||Drug: ADL5747 Drug: Placebo Drug: Pregabalin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2A, Randomized, Blinded, Placebo- and Active-controlled, 2-Period Crossover Study to Assess the Analgesic Efficacy, Safety, and Tolerability of ADL5747 in Subjects With Postherpetic Neuralgia|
|Study Start Date :||January 2010|
|Primary Completion Date :||December 2010|
|Study Completion Date :||December 2010|
ADL5747 150 milligrams (mg) administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods.
|Drug: ADL5747 Drug: Placebo|
Placebo Comparator: Placebo
Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.
Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.
Active Comparator: Pregabalin
Pregabalin administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
Other Name: Lyrica
- Change in Weekly Average Numeric Pain Rating Scale (NPRS) Score From Baseline to End of Treatment (Week 2 of Each Treatment Period) [ Time Frame: Baseline, Week 2 of Treatment Period 1 or 2 ]The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058642
|United States, Florida|
|Laszlo J. Mate, MD|
|West Palm Beach, Florida, United States, 33407-2450|
|Study Director:||Wei Du, MD||Cubist Pharmaceuticals LLC|