Trial Outcomes & Findings for Efficacy Study of Dextromethorphan to Treat Rheumatoid Arthritis (NCT NCT02368093)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

6 months

Results posted on

2015-03-31

Participant milestones
Measure	Dextromethorphan Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled. Dextromethorphan hydrobromide 120mg once daily were given for 6 months.	Placebo Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled. Placebo pills with the same appearance as Dextromethorphan hydrobromide tablets once daily were given for 6 months.
Overall Study STARTED	24	24
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Efficacy Study of Dextromethorphan to Treat Rheumatoid Arthritis

Baseline characteristics by cohort
Measure	Dextromethorphan Hydrobromide n=24 Participants Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast for 6 months	Placebo n=24 Participants Placebo pills with the same appearance as Detosiv tablets once daily for 6 months.	Total n=48 Participants Total of all reporting groups
Age, Continuous	52.2 years STANDARD_DEVIATION 11.6 • n=5 Participants	52.8 years STANDARD_DEVIATION 10.5 • n=7 Participants	52.5 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Taiwan	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants

Timeframe: 6 months

Outcome measures
Measure	Dextromethorphan Hydrobromide n=24 Participants Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast\] Dextromethorphan hydrobromide: 120mg per day with once daily dose taken after breakfast for 6 months	Placebo n=24 Participants placebo pills with the same appearance as Detosiv tablets.
Good European League Against Rheumatism (EULAR) Therapeutic Response Rate	6 participants	4 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Taichung Veterans General Hospital

Phone: 884-4-23592525