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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00607256
• Date of registration: 23/01/2008
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia
• Scientific title: A Multi-center, Long-term, Open-label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia
• Date of first enrolment: October 20, 2007
• Target sample size: 500
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00607256
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, Czech Republic, Czechia, France, Germany, Korea, Republic of, Netherlands, South Africa, Sweden, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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)

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Fibromyalgia

Intervention(s)

Drug: [S,S]-reboxetine

Primary Outcome(s)

Physical examination [Time Frame: 68 weeks]

12-lead ECG [Time Frame: 68 weeks]

Vital signs [Time Frame: 68 weeks]

Adverse events [Time Frame: 68 weeks]

Hematology/Biochemistry [Time Frame: 68 weeks]

Secondary Outcome(s)

Patient Global Impression of Change [Time Frame: 68 weeks]

Secondary ID(s)

A6061046

Source(s) of Monetary Support

Please refer to primary and secondary sponsors