Safety and Efficacy Study of ADL5859 in Participants With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov Identifier:
NCT00603265
First received: January 17, 2008
Last updated: June 4, 2015
Last verified: June 2015
Results First Received: April 21, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Peripheral Neuropathy
Neuropathic Pain
Interventions: Drug: ADL5859
Drug: Duloxetine
Drug: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
ADL5859 2 x 50 milligrams (mg) ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
Duloxetine 2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
Placebo 2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days

Participant Flow:   Overall Study
    ADL5859     Duloxetine     Placebo  
STARTED     76 [1]   78     72  
Received at Least 1 Dose of Study Drug     75     78     72  
COMPLETED     69     62     67  
NOT COMPLETED     7     16     5  
Adverse Event                 2                 11                 1  
Withdrawal by Subject                 1                 2                 1  
Lack of Efficacy                 3                 0                 3  
Lost to Follow-up                 0                 1                 0  
Out of Town, Ran Out of Study Drug                 0                 1                 0  
Participant Left Country, No Responses                 0                 1                 0  
Protocol Violation                 1                 0                 0  
[1] 1 participant was randomized in error and did not receive study medication



  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 participants who were randomized and treated with study medication.

Reporting Groups
  Description
ADL5859 2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
Duloxetine 2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
Placebo 2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
Total Total of all reporting groups

Baseline Measures
    ADL5859     Duloxetine     Placebo     Total  
Number of Participants  
[units: participants]
  75     78     72     225  
Age  
[units: Years]
Mean (Standard Deviation)
  59.7  (10.17)     59.1  (8.71)     56.2  (8.78)     58.3  (9.33)  
Gender  
[units: participants]
       
Female     35     39     27     101  
Male     40     39     45     124  



  Outcome Measures
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1.  Primary:   Change From Baseline in Mean Numeric Pain Rating Scale (NPRS) Score   [ Time Frame: Baseline, Week 4 ]

2.  Secondary:   Percentage of Responders   [ Time Frame: Baseline, Week 4 ]

3.  Secondary:   Patient Global Impression of Change (PGIC)   [ Time Frame: Week 4 ]

4.  Secondary:   Change in Sleep Interference Scale (SIS) From Baseline   [ Time Frame: Baseline, Week 4 ]

5.  Secondary:   Change From Baseline in the Evening Assessment of the 24-hour Overall Mean Pain Intensity Score   [ Time Frame: Baseline, Week 4 ]

6.  Secondary:   Change From Baseline in NPRS at Rest in the Clinic   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4 ]

7.  Secondary:   Change From Baseline in NPRS After Walking 50 Feet in the Clinic   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4 ]


  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
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  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


No publications provided


Responsible Party: Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov Identifier: NCT00603265     History of Changes
Other Study ID Numbers: 33CL231
Study First Received: January 17, 2008
Results First Received: April 21, 2015
Last Updated: June 4, 2015
Health Authority: United States: Food and Drug Administration