Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia

NCT00607256 | Terminated Phase 3 DMC

• 1 other identifier: A6061046
• Study Type: interventional
• Target: 500
• Locations: 11 countries
• Sites: 79

Brief Summary

To evaluate the lon-term safety and tolerability of \[S,S\]-reboxetine in patients with fibromyalgia

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (5)

• 12-lead ECG

  68 weeks

• Hematology/Biochemistry

  68 weeks

• Adverse events

  68 weeks

• Physical examination

  68 weeks

• Vital signs

  68 weeks

Secondary Outcomes (1)

• Patient Global Impression of Change

  68 weeks

Study Arms (1)

Open Label

EXPERIMENTAL

Drug: [S,S]-reboxetine

Interventions

[S,S]-reboxetine DRUG

S\_S reboxetine dosed daily.

Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of patients meeting the ACR criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)

You may not qualify if:

• Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia

Sponsors & Collaborators

• Pfizer: lead

Study Sites (79)

Pfizer Investigational Site

Orangevale, California, 95662, United States

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Santa Ana, California, 92705, United States

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Denver, Colorado, 80239, United States

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Jacksonville, Florida, 32216, United States

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Ocala, Florida, 34471, United States

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Ocala, Florida, 34474, United States

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West Palm Beach, Florida, 33407, United States

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Moline, Illinois, 61265, United States

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Prairie Village, Kansas, 66206, United States

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Lexington, Kentucky, 40509, United States

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Jefferson City, Missouri, 65109, United States

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St Louis, Missouri, 63141, United States

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Kenilworth, New Jersey, 07033, United States

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Rochester, New York, 14618, United States

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Staten Island, New York, 10312, United States

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Cary, North Carolina, 27511, United States

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Minot, North Dakota, 58701, United States

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Cincinnati, Ohio, 45219, United States

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Marion, Ohio, 43302, United States

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Medford, Oregon, 97504, United States

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Bethlehem, Pennsylvania, 18015, United States

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Duncansville, Pennsylvania, 16635, United States

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Cranston, Rhode Island, 02920, United States

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Cumberland, Rhode Island, 02864, United States

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Lincoln, Rhode Island, 02865, United States

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Warwick, Rhode Island, 02886, United States

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Anderson, South Carolina, 29621, United States

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Charleston, South Carolina, 29412, United States

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Greer, South Carolina, 29651, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77063, United States

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Lake Jackson, Texas, 77566, United States

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San Antonio, Texas, 78213, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84107, United States

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Richmond, Virginia, 23294, United States

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Virginia Beach, Virginia, 23455, United States

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Spokane, Washington, 99216, United States

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Milwaukee, Wisconsin, 53209, United States

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Brussels, 1070, Belgium

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Pellenberg, 3212, Belgium

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Kelowna, British Columbia, V1Y 2H4, Canada

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Moncton, New Brunswick, E1G 1A7, Canada

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Pointe-Claire, Quebec, H9R 3J1, Canada

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Sherbrooke, Quebec, J1H 1Z1, Canada

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Hlučín, 748 01, Czechia

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Pardubice, 530 02, Czechia

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Prague, 128 50, Czechia

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Zlín, 760 01, Czechia

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Lille, Cedex, 59037, France

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Nice, 06002, France

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Paris, 75181, France

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Berlin, 10117, Germany

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Berlin, 14109, Germany

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Eichstätt, 85072, Germany

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Göppingen, 73033, Germany

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Hamburg, 20095, Germany

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Mannheim, 68161, Germany

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München, 80336, Germany

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Wiesbaden, 65189, Germany

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Breda, 4819 EV, Netherlands

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Emmen, 7824 AA, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Boksburg, Gauteng, 1462, South Africa

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Pretoria, Gauteng, 0001, South Africa

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Panorama, Western Cape, 7500, South Africa

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Parow, Western Cape, 7500, South Africa

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Suwon, Kyeongki-do, 442-712, South Korea

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Gwangju, 501-757, South Korea

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Gothenburg, 412 55, Sweden

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Mölndal, 431 37, Sweden

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Stockholm, 115 22, Sweden

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Stockholm, 182 88, Sweden

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Cambridge, CB2 0QQ, United Kingdom

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Colchester, C04 5JL, United Kingdom

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Derby, DE1 2QY, United Kingdom

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Dudley, West Midlands, DY1 2HQ, United Kingdom

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Greenock, PA16 0XN, United Kingdom

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Paisley, PA2 7DE, United Kingdom

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Fibromyalgia

Interventions

O-methyl reboxetine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 5, 2008
• Study Start: October 20, 2007
• Primary Completion: May 18, 2009
• Study Completion: May 18, 2009
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

FR (3); BE (2); CA (4); ZA (4); SE (4); KR (2); GB (6); NL (3); US (39); CZ (4); DE (8)