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

Phase 3

Terminated

• Conditions: Fibromyalgia
• Interventions: Drug: [S,S]-reboxetine

• Registration Number: NCT00607256
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-20
• Study First Submitted: 2008-01-23
• Study First Submitted QC: 2008-01-23
• Study First Posted: 2008-02-05
• Primary Completion: 2009-05-18
• Study Completion: 2009-05-18
• Disposition First Submitted: 2011-06-07
• Status Verified: 2019-12
• Disposition First Submitted QC: 2019-12-11
• Last Update Submitted: 2019-12-11
• Disposition First Posted: 2019-12-13
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• 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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label	[S,S]-reboxetine	-

Primary Outcome Measures

Name	Time	Method
Adverse events	68 weeks
Vital signs	68 weeks
Physical examination	68 weeks
12-lead ECG	68 weeks
Hematology/Biochemistry	68 weeks

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change	68 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Paisley, United Kingdom