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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00612170 |
Purpose
This is a study to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia |
Drug: [S,S]-Reboxetine Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily (O.D.) in Patients With Fibromyalgia |
| Enrollment: | 1129 |
| Study Start Date: | December 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 3: Experimental |
Drug: [S,S]-Reboxetine
10 mg oral tablet once a day dosing
|
| 4: Sham Comparator |
Drug: Placebo
0 mg oral tablet once a day dosing
|
| 1: Experimental |
Drug: [S,S]-Reboxetine
4 mg oral tablet once a day dosing
|
| 2: Experimental |
Drug: [S,S]-Reboxetine
8 mg oral tablet once a day dosing
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 146 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A6061043, A6061043 |
| Study First Received: | January 29, 2008 |
| Last Updated: | July 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00612170 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Phase 3, safety and efficacy study, [S,S[-Reboxetine, Fibromyalgia |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Fibromyalgia Myofascial Pain Syndromes Physiological Effects of Drugs Nervous System Diseases Psychotropic Drugs |
Rheumatic Diseases Pharmacologic Actions Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Therapeutic Uses Central Nervous System Agents Antidepressive Agents Reboxetine |