A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00612170

Enrollment

1129

Registered

2008-02-11

Start date

2007-12-31

Completion date

2009-05-31

Last updated

2019-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Phase 3, safety and efficacy study, [S,S[-Reboxetine, Fibromyalgia

Brief summary

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.

Interventions

DRUG[S,S]-Reboxetine

10 mg oral tablet once a day dosing

DRUGPlacebo

0 mg oral tablet once a day dosing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female of any race, at least 18 years of age * Patients must meet the ACR criteria for fibromyalgia (ie, 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 (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia * Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder * A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression * History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features

Design outcomes

Primary

Measure	Time frame
Change from baseline in the endpoint mean pain score	14 weeks
Fibromyalgia Impact Questionnaire	14 weeks

Secondary

Measure	Time frame
Multidimensional Assessment of Fatigue	14 weeks
Hospital Anxiety and Depression Scale	14 weeks
Change from baseline in the endpoint mean sleep interference score	14 weeks
Sheehan Disability Score	14 weeks
Pain Visual Analogue Scale	14 weeks
Short Form 36	14 weeks
Patient Global Impression of Change	14 weeks

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026