Efficacy Study of Dextromethorphan to Treat Rheumatoid Arthritis
A Double-blind, Placebo-controlled, Therapeutic Trial With Antitussive Drug-Dextromethorphan: Aimed to Determine Its Therapeutic Effect in Patients With Rheumatoid Arthritis
1 other identifier
interventional
48
0 countries
N/A
Brief Summary
Rheumatoid arthritis were randomized to a 6-month treatment of oral dextromethorphan hydrobromide or placebo as an add-on therapy to traditional disease-modifying anti-rheumatic drugs (DMARDs). Disease activity were assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable rheumatoid-arthritis
Started Jan 2010
Typical duration for not_applicable rheumatoid-arthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 4, 2015
CompletedFirst Posted
Study publicly available on registry
February 20, 2015
CompletedResults Posted
Study results publicly available
March 31, 2015
CompletedMarch 31, 2015
March 1, 2015
2.7 years
February 4, 2015
March 22, 2015
March 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Good European League Against Rheumatism (EULAR) Therapeutic Response Rate
6 months
Study Arms (2)
Dextromethorphan hydrobromide
EXPERIMENTALDextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast\]
Placebo
PLACEBO COMPARATORplacebo pills with the same appearance as Detosiv tablets.
Interventions
120mg per day with once daily dose taken after breakfast for 6 months
Eligibility Criteria
You may qualify if:
- Patients fulfilling the 2010 criteria of the American College of Rheumatology (ACR) for RA
You may not qualify if:
- Receive biological therapy for RA, including Etanercept, Adalimumab, Golimumab, Tocilizumab, Rituximab, Abatacept.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Der-Yuan Chen
- Organization
- Taichung Veterans General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Der-Yuan Chen, M.D., Ph.D.
Division of Allergy,Immunology and Rheumatology, Taichung Veterans General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2015
First Posted
February 20, 2015
Study Start
January 1, 2010
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
March 31, 2015
Results First Posted
March 31, 2015
Record last verified: 2015-03