A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00357825
First received: July 26, 2006
Last updated: May 14, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to assess the safety and effectiveness of [S,S]-Reboxetine in patients with fibromyalgia.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: [S,S]-Reboxetine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study of [S,S]-Reboxetine Administered Once Daily in Patients With Fibromyalgia |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Weekly Average Pain Score from the Daily Pain Diary.
Secondary Outcome Measures:
- Fibromyalgia Impact Questionnaire (FIQ) Total Score
- Patient Global Impression of Change
- Short-Form 36 Health Survey (SF 36)
- Sheehan Disability Scale
- Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale)
- Quality of Sleep Score from the Daily Sleep Diary
- Multidimensional Assessment of Fatigue (MAF)
- Hospital Anxiety and Depression Scales (HADS)
- Short-Form McGill Pain Questionnaire (SF-MPQ)
- Fibromyalgia Health Assessment Questionnaire (F-HAQ)
- Safety and Tolerability
- Exposure Response Relationship Between Daily Dose and Daily Pain Score
| Estimated Enrollment: | 246 |
| Study Start Date: | August 2006 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- At screening patients must meet the ACR criteria for fibromyalgia (i.e. widespread pain for at least 3 months, and pain in at least 11 of 18 specific tender point sites).
- At screening and randomization, patients must have a score of >/=40mm on the Visual Analog Scale (VAS) of the Short-Form-McGill Pain Questionnaire (SF-MPQ).
Exclusion Criteria:
- Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia.
- Patients with severe hepatic impairment.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357825
Hide Study Locations
Hide Study LocationsLocations
| United States, Arizona | |
| Pfizer Investigational Site | |
| Chandler, Arizona, United States, 85225 | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85013 | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85007 | |
| Pfizer Investigational Site | |
| Sun City, Arizona, United States, 85351 | |
| Pfizer Investigational Site | |
| Tucson, Arizona, United States, 85741 | |
| United States, California | |
| Pfizer Investigational Site | |
| Auburn, California, United States, 95602 | |
| Pfizer Investigational Site | |
| Orangevale, California, United States, 95662 | |
| Pfizer Investigational Site | |
| Pismo Beach, California, United States, 93449 | |
| Pfizer Investigational Site | |
| Walnut Creek, California, United States, 94598 | |
| United States, Delaware | |
| Pfizer Investigational Site | |
| Newark, Delaware, United States, 19713 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| DeLand, Florida, United States, 32720 | |
| Pfizer Investigational Site | |
| Ocala, Florida, United States, 34474 | |
| Pfizer Investigational Site | |
| Ocala, Florida, United States, 34471 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33606 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33614 | |
| Pfizer Investigational Site | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Gurnee, Illinois, United States, 60031 | |
| Pfizer Investigational Site | |
| Moline, Illinois, United States, 61265 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Indianapolis, Indiana, United States, 46250 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Pratt, Kansas, United States, 67124 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States, 40509 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Fall River, Massachusetts, United States, 02720 | |
| Pfizer Investigational Site | |
| Mansfield, Massachusetts, United States, 02048 | |
| Pfizer Investigational Site | |
| Wellesley Hills, Massachusetts, United States, 02481-2106 | |
| Pfizer Investigational Site | |
| Worcester, Massachusetts, United States, 01610 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| Jefferson City, Missouri, United States, 65109 | |
| Pfizer Investigational Site | |
| Kansas City, Missouri, United States, 64106 | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Lincoln, Nebraska, United States, 68516 | |
| United States, New York | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10022-1009 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Cary, North Carolina, United States, 27511 | |
| Pfizer Investigational Site | |
| Charlotte, North Carolina, United States, 28209-3734 | |
| Pfizer Investigational Site | |
| Charlotte, North Carolina, United States, 28210 | |
| Pfizer Investigational Site | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, North Dakota | |
| Pfizer Investigational Site | |
| Minot, North Dakota, United States, 58701 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45219 | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45227 | |
| Pfizer Investigational Site | |
| Dayton, Ohio, United States, 45402 | |
| Pfizer Investigational Site | |
| Toledo, Ohio, United States, 43623 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Eugene, Oregon, United States, 97401 | |
| Pfizer Investigational Site | |
| Medford, Oregon, United States, 97504 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Altoona, Pennsylvania, United States, 16602 | |
| Pfizer Investigational Site | |
| Bensalem, Pennsylvania, United States, 19020 | |
| Pfizer Investigational Site | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Pfizer Investigational Site | |
| Camp Hill, Pennsylvania, United States, 17011 | |
| Pfizer Investigational Site | |
| Duncansville, Pennsylvania, United States, 16635-0909 | |
| United States, Rhode Island | |
| Pfizer Investigational Site | |
| Cumberland, Rhode Island, United States, 02864 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Myrtle Beach, South Carolina, United States, 29572 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Milan, Tennessee, United States, 38358 | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Georgetown, Texas, United States, 78626 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77024 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77030 | |
| Pfizer Investigational Site | |
| Lake Jackson, Texas, United States, 77566 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78213 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84102 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Virginia Beach, Virginia, United States, 23455 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Everett, Washington, United States, 98201 | |
| Pfizer Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Milwaukee, Wisconsin, United States, 53209 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00357825 History of Changes |
| Other Study ID Numbers: | A6061034 |
| Study First Received: | July 26, 2006 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Reboxetine Antidepressive Agents Psychotropic Drugs |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013