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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
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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:


Further study details as provided by Grünenthal GmbH:

Primary Outcome Measures:
  • Average Pain Intensity [ Time Frame: Baseline; last 7 days of 12-week maintenance ]
    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 ]
  • 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 ]
  • 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 ]
  • Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS). [ Time Frame: Baseline; weekly mean ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • Time to Treatment Discontinuation Due to Lack of Efficacy. [ Time Frame: Baseline to time to treatment discontinuation ]
  • Assessment of Rescue Medication Usage During the 4-week Titration. [ Time Frame: 4-week titration phase ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Pain
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 25, 2017