A randomized, double-blind, placebo-controlled trial of ramosetron in patients with fibromyalgia.

Not Applicable

Recruiting

• Conditions: Diseases of the musculo-skeletal system and connective tissue

• Registration Number: KCT0002651
• Lead Sponsor: Chonnam National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients between 18 and 80 years of age who meet the following criteria:
Disease: The definition of fibromyalgia is based on the criteria published by the American Society of Rheumatology (ACR) in 2010, and the patients who meet the following criteria are eligible.
1) The patients who meet the 2010 ACR criteria for fibromyalgia
2) No response after 4 weeks of standard medication
3) Pain VAS 40 and FIQ score of 45 or more
4) The patients who are fully informed about the study and signed the informed consent.

Exclusion Criteria

1) Patients complaining of pain due to other rheumatic diseases.
2) The patients who had a certain diseases such as uncontrolled tumors
3) If patients have uncontrolled illness or psychiatric illness
4) If patients have a history of drug addiction
5) Patients who are pregnant or expect to become pregnant
6) If there is a previous history of study drug use before 30 days
7) Patients with severe complications due to drug allergy
are excluded from this study.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain VAS

Secondary Outcome Measures

Name	Time	Method
Fibromyalgia Impact Questionnaire (FIQ)