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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02368093
Enrollment
48
Registered
2015-02-20
Start date
2010-01-31
Completion date
2012-09-30
Last updated
2015-03-31

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

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis

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.

Interventions

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

Sponsors

TSH Biopharm Corporation Limited
CollaboratorINDUSTRY
Taichung Veterans General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Good European League Against Rheumatism (EULAR) Therapeutic Response Rate6 months

Participant flow

Participants by arm

ArmCount
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 for 6 months
24
Placebo
Placebo pills with the same appearance as Detosiv tablets once daily for 6 months.
24
Total48

Baseline characteristics

CharacteristicDextromethorphan HydrobromidePlaceboTotal
Age, Continuous52.2 years
STANDARD_DEVIATION 11.6
52.8 years
STANDARD_DEVIATION 10.5
52.5 years
STANDARD_DEVIATION 11
Region of Enrollment
Taiwan
24 participants24 participants48 participants
Sex: Female, Male
Female
19 Participants19 Participants38 Participants
Sex: Female, Male
Male
5 Participants5 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Good European League Against Rheumatism (EULAR) Therapeutic Response Rate

Time frame: 6 months

ArmMeasureValue (NUMBER)
Dextromethorphan HydrobromideGood European League Against Rheumatism (EULAR) Therapeutic Response Rate6 participants
PlaceboGood European League Against Rheumatism (EULAR) Therapeutic Response Rate4 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026