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Sponsors and Collaborators: |
Massachusetts General Hospital Takeda Global Research & Development Center, Inc. |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00753623 |
This proposal is to conduct a double-blinded, randomized, placebo-controlled, crossover clinical study to examine the hypothesis that ramelteon would reduce pain score and improve functional status in subjects with neuropathic pain.
Condition | Intervention |
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Neuropathic Pain |
Drug: Ramelteon Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Clinical Management of Neuropathic Pain With Ramelteon |
Estimated Enrollment: | 96 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
In a crossover design, a subject will be first assigned to the ramelteon or placebo arm and then switched over to the opposite arm.
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Drug: Ramelteon
ramelteon (8 mg)
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2: Placebo Comparator
In a crossover design, a subject will be first assigned to the ramelteon or placebo arm and then switched over to the opposite arm.
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Drug: Placebo
In a crossover design, a subject will be first assigned to the ramelteon or placebo arm and then switched over to the opposite arm.
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Neuropathic pain is a chronic pain condition resulting from injury to the peripheral and/or central nervous system. Despite extensive research over the last several decades, neuropathic pain remains poorly managed due to the lack of effective pharmacological tools. To date, little has been known regarding the effect of melatonin and its analogues on clinical neuropathic pain. We propose to conduct a randomized, placebo-controlled, double-blinded, and crossover clinical trial to examine the effect of ramelteon [a melatonin (MT) 1/ MT2 receptor agonist] on neuropathic pain. We hypothesize that ramelteon would reduce pain score and improve functional status in subjects with neuropathic pain.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mary Houghton, B.A. | 617-726-3744 | mhoughton1@partners.org |
Contact: Charlene Malarick, R.N. | 617-724-0253 | cmalarick@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Mary M. Houghton, BA 617-726-3744 mhoughton1@partners.org | |
Contact: Charlene Malarick, RN 617-724-0253 cmalarick@partners.org | |
Principal Investigator: Jianren Mao, M..D., Ph.D. | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Mary M. Houghton, BA 617-726-3744 mhoughton1@partners.org | |
Contact: Charlene Malarick, RN 617-724-0253 cmalarick@partners.org |
Principal Investigator: | Jianren Mao, M.D., Ph. D. | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Jianren Mao, M.D., Ph.D., Dir., MGH Center for Translational Pain Research ) |
Study ID Numbers: | 2008P-000988 |
Study First Received: | September 15, 2008 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00753623 History of Changes |
Health Authority: | United States: Institutional Review Board |
Pain Neuropathic pain Pain scores |
Pain |