Efficacy Study of Dextromethorphan to Treat Rheumatoid Arthritis

NCT ID: NCT02368093

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-09-30

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dextromethorphan hydrobromide

Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast\]

Group Type: EXPERIMENTAL

Dextromethorphan hydrobromide

Intervention Type: DRUG

120mg per day with once daily dose taken after breakfast for 6 months

Placebo

placebo pills with the same appearance as Detosiv tablets.

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Dextromethorphan hydrobromide

120mg per day with once daily dose taken after breakfast for 6 months

Intervention Type: DRUG

Other Intervention Names

Detosiv Slow Release®

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TSH Biopharm Corporation Limited

INDUSTRY

Sponsor Role: collaborator

Taichung Veterans General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Der-Yuan Chen, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Division of Allergy,Immunology and Rheumatology, Taichung Veterans General Hospital

Other Identifiers

C09060-1

Identifier Type: -

Identifier Source: org_study_id