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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0002651
Enrollment
80
Registered
2018-01-09
Start date
2017-08-21
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Drug : 0.3 mg of Nasea is mixed with physiological saline (0.9&#37
sodium chloride) and injected intravenously with 5 cc. In order to achieve a double blindness, inject a syringe of the same shape and capacity as the control saline. Ramosetron is a transparent compon

Sponsors

Chonnam National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Pain VAS

Secondary

MeasureTime frame
Fibromyalgia Impact Questionnaire (FIQ)

Countries

Korea, Republic of

Contacts

Public ContactDongjin Park

Chonnam National University Hospital

dongjin02@hanmail.net+82-62-670-9492

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026