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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
History of Changes
  Purpose

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


Condition Intervention Phase
Painful Diabetic Neuropathy
 Drug: GRT3938Y
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Grünenthal GmbH:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 553
Study Start Date: November 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A GRT3983Y
Participants randomly assigned to receive GRT3983Y.
 Drug: GRT3938Y
Overencapsulated tablets of GRT3983Y, 100 to 300mg daily dose, 16 weeks treatment.
Placebo Comparator: B Placebo
Participants randomly assigned to placebo.
 Drug: Placebo
Overencapsulated tablets of placebo, 16 weeks treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056315

  Show 61 Study Locations
Sponsors and Collaborators
Grünenthal GmbH
Investigators
Study Director: Study Director Grünenthal GmbH
  More Information

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

Keywords provided by Grünenthal GmbH:
Analgesia
Diabetic Neuropathy
Neuropathic pain
Painful
Chronic pain

Additional relevant MeSH terms:
Diabetic Neuropathies
Pain
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
 Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 16, 2013