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Study to Assess the Efficacy, Safety, and Tolerability of ADL5747 in Participants With Postherpetic Neuralgia

This study has been terminated.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT01058642
First received: January 27, 2010
Last updated: July 8, 2015
Last verified: July 2015
Results First Received: April 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Postherpetic Neuralgia
Interventions: Drug: ADL5747
Drug: Placebo
Drug: Pregabalin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment Sequence 1: Placebo Then Pregabalin

Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1.

A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.

Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 2; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID). This was followed by a dose of pregabalin 75 mg BID (1 pregabalin 75-mg capsule and 1 placebo capsule BID) for 3 days as a taper period followed by placebo orally BID during the last 4 days.

Treatment Sequence 2: Pregabalin Then Placebo

Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 1; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID).

At the end of Treatment Period 1 and the start of the first week of the 2-week washout period, participants took a tapered pregabalin dose (75 mg BID) during the first 3 days of the week, followed by placebo orally BID during the last 4 days.

Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2.

At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week.

Treatment Sequence 3: Placebo Then ADL5747

Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1.

A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.

During Treatment Period 2, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days.

At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week

Treatment Sequence 4: ADL5747 Then Placebo

During Treatment Period 1, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days.

A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.

Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2.

At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week.


Participant Flow for 3 periods

Period 1:   Treatment Period 1
    Treatment Sequence 1: Placebo Then Pregabalin     Treatment Sequence 2: Pregabalin Then Placebo     Treatment Sequence 3: Placebo Then ADL5747     Treatment Sequence 4: ADL5747 Then Placebo  
STARTED     9     12     11     9  
Received at Least 1 Dose of Study Drug     9     12     11     9  
COMPLETED     7     11     9     7  
NOT COMPLETED     2     1     2     2  
Adverse Event                 0                 1                 1                 0  
Physician Decision                 0                 0                 1                 0  
Withdrawal by Subject                 1                 0                 0                 0  
Lack of Efficacy                 0                 0                 0                 1  
Protocol Violation                 0                 0                 0                 1  
Lack of Compliance with Study Drug                 1                 0                 0                 0  

Period 2:   Washout Period
    Treatment Sequence 1: Placebo Then Pregabalin     Treatment Sequence 2: Pregabalin Then Placebo     Treatment Sequence 3: Placebo Then ADL5747     Treatment Sequence 4: ADL5747 Then Placebo  
STARTED     7     11     9     7  
COMPLETED     7     11     9     7  
NOT COMPLETED     0     0     0     0  

Period 3:   Treatment Period 2
    Treatment Sequence 1: Placebo Then Pregabalin     Treatment Sequence 2: Pregabalin Then Placebo     Treatment Sequence 3: Placebo Then ADL5747     Treatment Sequence 4: ADL5747 Then Placebo  
STARTED     7     11     9     7  
Received at Least 1 Dose of Study Drug     7     11     9     7  
COMPLETED     7     11     9     7  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants.

Reporting Groups
  Description
Treatment Sequence 1: Placebo Then Pregabalin

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.

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.

Treatment Sequence 2: Pregabalin Then Placebo

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.

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.

Treatment Sequence 3: Placebo Then ADL5747

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.

ADL5747: 150 mg BID administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods.

Treatment Sequence 4: ADL5747 Then Placebo

ADL5747: 150 mg BID administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days during 1 of 2 Treatment Periods.

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.

Total Total of all reporting groups

Baseline Measures
    Treatment Sequence 1: Placebo Then Pregabalin     Treatment Sequence 2: Pregabalin Then Placebo     Treatment Sequence 3: Placebo Then ADL5747     Treatment Sequence 4: ADL5747 Then Placebo     Total  
Number of Participants  
[units: participants]
  9     12     11     9     41  
Age  
[units: years]
Mean (Standard Deviation)
  56.8  (8.17)     58.9  (16.01)     67.1  (6.98)     67.4  (8.03)     62.5  (11.46)  
Gender  
[units: participants]
         
Female     7     4     7     4     22  
Male     2     8     4     5     19  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     0     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     4     2     0     2     8  
White     5     10     11     7     33  
More than one race     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
United States     9     12     11     9     41  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
On the basis of the interim analysis, the results indicated that ADL5747 did not show sufficient efficacy to continue the study; therefore, formal and final efficacy analyses were not generated for this study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Clinical Research
Organization: Cubist Pharmaceuticals
phone: (781) 860-8660



Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01058642     History of Changes
Other Study ID Numbers: 40CL234
Study First Received: January 27, 2010
Results First Received: April 23, 2015
Last Updated: July 8, 2015
Health Authority: United States: Food and Drug Administration