A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y

This study has been terminated.
(Trial was stopped due to difficult enrolment)
Sponsor:
Information provided by (Responsible Party):
Grünenthal GmbH
ClinicalTrials.gov Identifier:
NCT01056315
First received: December 21, 2009
Last updated: April 19, 2013
Last verified: April 2013
Results First Received: April 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Painful Diabetic Neuropathy
Interventions: Drug: GRT3938Y
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
503 participants were excluded from the trial before assignment to a treatment group because they did not meet the inclusion and or exclusion criteria.

Reporting Groups
  Description
GRT3983Y No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    GRT3983Y     Placebo  
STARTED     27     23  
COMPLETED     13     12  
NOT COMPLETED     14     11  



  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.
No text entered.

Reporting Groups
  Description
GRT3983Y No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    GRT3983Y     Placebo     Total  
Number of Participants  
[units: participants]
  27     23     50  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     14     34  
>=65 years     7     9     16  
Age  
[units: years]
Mean ± Standard Deviation
  59.38  ± 8.942     60.27  ± 10.438     59.79  ± 9.568  
Gender  
[units: participants]
     
Female     12     8     20  
Male     15     15     30  
Region of Enrollment  
[units: participants]
     
United States     27     23     50  



  Outcome Measures
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1.  Primary:   Average Pain Intensity   [ Time Frame: Baseline; last 7 days of 12-week maintenance ]

2.  Secondary:   Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over the Entire 12-week Maintenance   [ Time Frame: Baseline, Daily scores over entire 12 week maintenance ]

3.  Secondary:   Proportion of Subjects Achieving Various Levels of Pain Improvement (Including 30% and 50%) Based on the Percent Change From Baseline to the Last 7 Days of the 12-week Maintenance on an 11-point NRS (Responder Analysis).   [ Time Frame: Baseline, Last 7 days of 12-week maintenance ]

4.  Secondary:   Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over Each Week of Maintenance.   [ Time Frame: Baseline; daily scores over each week of maintenance ]

5.  Secondary:   Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS).   [ Time Frame: Baseline; weekly mean ]

6.  Secondary:   Change From Baseline of the Weekly Mean of Current Pain Intensity (on an 11-point NRS) in the Evening and in the Morning, Respectively.   [ Time Frame: Baseline, weekly mean ]

7.  Secondary:   Brief Pain Inventory Scores: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, and Day 113 (Final Visit).   [ Time Frame: Baseline, weekly mean ]

8.  Secondary:   Neuropathic Pain Symptoms Inventory: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99 and Day 113 (Final Visit)   [ Time Frame: Baseline, weekly mean ]

9.  Secondary:   Patient Global Impression of Change Using a 7-point Verbal Rating Scale, on Day 29, Day 71 and Day 113 (Final Visit).   [ Time Frame: Day 29, Day 71 and Day 113. ]

10.  Secondary:   Short Form 36 Health Survey (SF-36®): Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).   [ Time Frame: Baseline, Day 29, Day 71 and Day 113. ]

11.  Secondary:   EuroQol-5 Dimension Health Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).   [ Time Frame: Baseline, Day 29, Day 71 and Day 113. ]

12.  Secondary:   Assessment of Each Item of the Leeds Sleep Evaluation Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).   [ Time Frame: Baseline, Day 29, Day 71 and Day 113. ]

13.  Secondary:   Hospital Anxiety and Depression Scale: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).   [ Time Frame: Baseline, Day 29, Day 71 and Day 113. ]

14.  Secondary:   Time to Treatment Discontinuation Due to Lack of Efficacy.   [ Time Frame: Baseline to time to treatment discontinuation ]

15.  Secondary:   Assessment of Rescue Medication Usage During the 4-week Titration.   [ Time Frame: 4-week titration phase ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No participants were analyzed as the study was terminated  


Results Point of Contact:  
Name/Title: Study Director
Organization: Grünenthal
phone: +49 (0)-241-569-3223
e-mail: clinical-trials@grunenthal.com


No publications provided


Responsible Party: Grünenthal GmbH
ClinicalTrials.gov Identifier: NCT01056315     History of Changes
Other Study ID Numbers: 131885
Study First Received: December 21, 2009
Results First Received: April 5, 2012
Last Updated: April 19, 2013
Health Authority: United States: Food and Drug Administration