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

December 21, 2009
April 19, 2013
November 2009
January 2011   (final data collection date for primary outcome measure)
Average Pain Intensity [ Time Frame: Baseline; last 7 days of 12-week maintenance ] [ Designated as safety issue: No ]
The primary efficacy endpoint is the change from baseline in the mean of the daily average pain intensity scores (on an 11-point NRS) over the last 7 days of the 12-week maintenance (Week 16).
Average pain intensity [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01056315 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS). [ Time Frame: Baseline; weekly mean ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Time to Treatment Discontinuation Due to Lack of Efficacy. [ Time Frame: Baseline to time to treatment discontinuation ] [ Designated as safety issue: No ]
  • Assessment of Rescue Medication Usage During the 4-week Titration. [ Time Frame: 4-week titration phase ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Responder (30% and 50% pain reduction) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y
A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Analgesic Efficacy and Safety of a New Analgesic Compared to Placebo in Subjects With Painful Diabetic Peripheral Neuropathy

This trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (DPN).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Painful Diabetic Neuropathy
  • Drug: GRT3938Y
    Overencapsulated tablets of GRT3983Y, 100 to 300mg daily dose, 16 weeks treatment.
  • Drug: Placebo
    Overencapsulated tablets of placebo, 16 weeks treatment.
  • Experimental: A GRT3983Y
    Participants randomly assigned to receive GRT3983Y.
    Intervention: Drug: GRT3938Y
  • Placebo Comparator: B Placebo
    Participants randomly assigned to placebo.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
553
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Symmetrical painful diabetic peripheral neuropathy

Exclusion Criteria:

  • History of hypersensitivity, allergy or contraindication to opioids and acetaminophen
  • Confounding painful conditions
  • Significant vascular disease
  • History or risk of seizure
  • Chronic disease that might effect drug absorption, distribution, metabolism, or excretion
  • Female subjects who are being pregnant or breastfeeding
  • Evidence or history of alcohol, medication, or drug abuse
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01056315
131885
No
Grünenthal GmbH
Grünenthal GmbH
Not Provided
Study Director: Study Director Grünenthal GmbH
Grünenthal GmbH
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP