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Sponsored by: |
Vernalis (R&D) Ltd |
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Information provided by: | Vernalis (R&D) Ltd |
ClinicalTrials.gov Identifier: | NCT00794430 |
Randomised, double-blind, placebo-controlled, parallel group, multicentre study of oral doses of V3381, titrated to effect. A 2-week single-blind run-in period will be followed by a 13 week double-blind titration and maintenance phase. Doses will be titrated up in 100 mg bid increments every one or two weeks, starting from 100 mg bid. A 2 week follow-up period will conclude patient participation in the study.
Condition | Intervention | Phase |
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Diabetic Peripheral Neuropathic Pain |
Drug: V3381 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Parallel Group Study of the Safety, Tolerability and Efficacy of V3381 for up to 13 Weeks in Patients With Diabetic Peripheral Neuropathic Pain (DPNP) |
Estimated Enrollment: | 150 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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V3381: Experimental
Patients will be randomised to either V3381 or placebo. They will start the study with a single-blind 2-week run in phase prior to entering the double-blind 13-week treatment titration and maintenance phase.Doses will be titrated up in 100 mg bid increments every one or two weeks, starting from 100 mg bid. The daily maximum dose of V3381 will be 400 mg.
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Drug: V3381
100 mg capsules, titrated to a maximum of 200 mg bid for 13 weeks
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Placebo: Placebo Comparator
Patients will be randomised to either V3381 or placebo. They will start the study with a single-blind 2-week run in phase prior to entering the double-blind 13-week treatment titration and maintenance phase.
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Drug: Placebo
Capsule, bid, for 13 weeks
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Females should be of non child-bearing potential
Additionally, at the baseline visit:
Exclusion Criteria:
United States, Massachusetts | |
Brigham and Women's Hospital | Not yet recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Christine Sang 617-525-7246 csang@partners.org | |
Principal Investigator: Christine Sang | |
United States, Texas | |
dgd Research | Recruiting |
San Antonio, Texas, United States, 78229-4801 | |
Contact: Sherwyn Schwartz 210-615-5565 cadeyemi@dgdresearch.com | |
Principal Investigator: Sherwyn Schwartz | |
Canada | |
LMC Endocrinology | Not yet recruiting |
Thornhill, Canada, L4J 8L7 | |
Contact: Ronald Goldenberg 905-763-8660 ronald.goldenberg@LMC.ca | |
Principal Investigator: Ronald Goldenberg | |
LMC Endocrinology | Not yet recruiting |
Toronto, Canada, M4R 2G4 | |
Contact: Ronnie Aronson 416-789-9188 ronnie.aronson@LMC.ca | |
Principal Investigator: Ronnie Aronson |
Responsible Party: | Brigham and Woman's Hospital ( Dr. Christine Sang, MD, MPH ) |
Study ID Numbers: | V3381-2DPNP-02 |
Study First Received: | November 19, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00794430 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Czech Republic: State Institute for Drug Control |
Safety Tolerability Efficacy Patients Diabetic peripheral neuropathic pain. |
Neuromuscular Diseases Diabetic Neuropathies Peripheral Nervous System Diseases Diabetes Mellitus |
Endocrine System Diseases Pain Endocrinopathy Diabetes Complications |
Nervous System Diseases |