Study to Assess the Efficacy, Safety, and Tolerability of ADL5747 in Participants With Postherpetic Neuralgia
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|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|
|Actual Primary Completion Date :||December 2010|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|