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

A Multi-center, Long-term, Open-label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00607256

Enrollment

500

Registered

2008-02-05

Start date

2007-10-20

Completion date

2009-05-18

Last updated

2019-12-13

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

Conditions

Fibromyalgia

Brief summary

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

Interventions

DRUG[S,S]-reboxetine

S\_S reboxetine dosed daily.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Patient Global Impression of Change	68 weeks

Countries

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

Outcome results

None listed

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