Skip to main content
OpenTrials
Completed

NCT Number: NCT00357825

A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia

The purpose of this study is to assess the safety and effectiveness of [S,S]-Reboxetine in patients with fibromyalgia.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At screening patients must meet the ACR criteria for fibromyalgia (i.e. widespread pain for at least 3 months, and pain in at least 11 of 18 specific tender point sites).
  • At screening and randomization, patients must have a score of >/=40mm on the Visual Analog Scale (VAS) of the Short-Form-McGill Pain Questionnaire (SF-MPQ).

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.
  • Patients with severe hepatic impairment.

Treatment and study plan

[S,S]-Reboxetine

Drug

Primary outcomes

  1. Weekly Average Pain Score from the Daily Pain Diary.

Secondary outcomes

  1. Fibromyalgia Impact Questionnaire (FIQ) Total Score

  2. Patient Global Impression of Change

  3. Short-Form 36 Health Survey (SF 36)

  4. Sheehan Disability Scale

  5. Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale)

  6. Quality of Sleep Score from the Daily Sleep Diary

  7. Multidimensional Assessment of Fatigue (MAF)

  8. Hospital Anxiety and Depression Scales (HADS)

  9. Short-Form McGill Pain Questionnaire (SF-MPQ)

  10. Fibromyalgia Health Assessment Questionnaire (F-HAQ)

  11. Safety and Tolerability

  12. Exposure Response Relationship Between Daily Dose and Daily Pain Score

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study of [S,S]-Reboxetine Administered Once Daily in Patients With Fibromyalgia

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 28, 2006
Registry last updated
May 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.