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| Name | Class |
|---|---|
| TSH Biopharm Corporation Limited | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextromethorphan hydrobromide | Experimental | Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast] |
|
| Placebo | Placebo Comparator | placebo pills with the same appearance as Detosiv tablets. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextromethorphan hydrobromide | Drug | 120mg per day with once daily dose taken after breakfast for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Good European League Against Rheumatism (EULAR) Therapeutic Response Rate | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Der-Yuan Chen, M.D., Ph.D. | Division of Allergy,Immunology and Rheumatology, Taichung Veterans General Hospital | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Good European League Against Rheumatism (EULAR) Therapeutic Response Rate | Posted | Number | participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Der-Yuan Chen | Taichung Veterans General Hospital | 884-4-23592525 | 3354 | dychen@vghtc.gov.tw |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D003915 | Dextromethorphan |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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Placebo pills with the same appearance as Detosiv tablets once daily for 6 months. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Ethnicity of participants | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |