Efficacy Study of Dextromethorphan to Treat Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dextromethorphan hydrobromide
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis
Eligibility Criteria
Inclusion Criteria:
- Patients fulfilling the 2010 criteria of the American College of Rheumatology (ACR) for RA
Exclusion Criteria:
- Receive biological therapy for RA, including Etanercept, Adalimumab, Golimumab, Tocilizumab, Rituximab, Abatacept.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dextromethorphan hydrobromide
Placebo
Arm Description
Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast]
placebo pills with the same appearance as Detosiv tablets.
Outcomes
Primary Outcome Measures
Good European League Against Rheumatism (EULAR) Therapeutic Response Rate
Secondary Outcome Measures
Full Information
NCT ID
NCT02368093
First Posted
February 4, 2015
Last Updated
March 22, 2015
Sponsor
Taichung Veterans General Hospital
Collaborators
TSH Biopharm Corporation Limited
1. Study Identification
Unique Protocol Identification Number
NCT02368093
Brief Title
Efficacy Study of Dextromethorphan to Treat Rheumatoid Arthritis
Official Title
A Double-blind, Placebo-controlled, Therapeutic Trial With Antitussive Drug-Dextromethorphan: Aimed to Determine Its Therapeutic Effect in Patients With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital
Collaborators
TSH Biopharm Corporation Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Biologic-naïve rheumatoid arthritis (RA) patients who fulfilled the 2010 criteria of the American College of Rheumatology (ACR) for RA were enrolled. All patient were randomized to a 6-month treatment with either oral DXM [dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan) with T1/2 = 7.75h, Tmax = 4.83h, Cmax = 14.6 ng mL-1 and mean residual time = 5.86 h, 120mg per day with once daily dose taken after breakfast] or placebo pills with the same appearance as DXM tablets. The randomization was performed by the pharmacy of the Taichung Veterans General Hospital. Non-study medications were not changed during the course of study.
Twenty-four patients received add-one DXM therapy and the other 24 patients received traditional DMARDs alone in stable dose. Disease activity was assessed by the 28-joint disease activity score (DAS28) before starting add-on DXM therapy (as a baseline) and at the end of 6 months of therapy with or without add-on DXM. Patients were categorized as good, moderate or poor responders based on the amount of change in the DAS28 and the level of DAS28 reached. Good responders were defined as patients who had a decrease in DAS28 from baseline (∆DAS28)>1.2 and a DAS28≦3.2 at evaluation time; moderate responders had either ∆DAS28>1.2 and a DAS28>3.2 or ∆DAS28 of 0.6-1.2 and a DAS28≦5.1 at evaluation time; and poor responders were those who had either ∆DAS28<0.6 or a DAS28>5.1 at evaluation time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dextromethorphan hydrobromide
Arm Type
Experimental
Arm Description
Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast]
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo pills with the same appearance as Detosiv tablets.
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan hydrobromide
Other Intervention Name(s)
Detosiv Slow Release®
Intervention Description
120mg per day with once daily dose taken after breakfast for 6 months
Primary Outcome Measure Information:
Title
Good European League Against Rheumatism (EULAR) Therapeutic Response Rate
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients fulfilling the 2010 criteria of the American College of Rheumatology (ACR) for RA
Exclusion Criteria:
Receive biological therapy for RA, including Etanercept, Adalimumab, Golimumab, Tocilizumab, Rituximab, Abatacept.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Der-Yuan Chen, M.D., Ph.D.
Organizational Affiliation
Division of Allergy,Immunology and Rheumatology, Taichung Veterans General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Dextromethorphan to Treat Rheumatoid Arthritis
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