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| ID | Type | Description | Link |
|---|---|---|---|
| TRAMPAI1002 | Other Identifier | Janssen Scientific Affairs, LLC | |
| V01-TRAA-501 | Other Identifier | Valeant Pharmaceuticals International Inc | |
| 2013-01-00 | Other Identifier | Cipher Pharmaceuticals Inc |
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| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
| Cipher Pharmaceuticals Inc. | INDUSTRY |
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The purpose of this study is to determine the safety and tolerability profile of tramadol hydrochloride (HCl) given as oral doses every 6 hours, within the range of dosages supported by currently available toxicology and clinical data (200 mg to 600 mg per day).
This is a randomized (study drug assigned by chance), sequential-cohort (time lagged), double-blind (neither the participant or the study doctor will know the name of the assigned treatment), parallel-group, placebo-controlled, 3-arm (participants will be assigned to 1 of 3 treatment groups), single-center, Phase 1 study of multiple ascending doses of tramadol HCl in healthy adult volunteers. Thirty participants (15 men and 15 women) will be sequentially assigned to 1 of 3 treatment groups of 10 subjects each (5 men and 5 women). Participants in each treatment group will receive a total of 9 oral doses (one every 6 hours) of tramadol HCl or placebo, in the ratio of 4:1. The study includes a screening phase and a double-blind treatment phase. The treatment phase will consist of 3 treatment periods separated by a 5-day safety review period before the next ascending dose of study drug is administered to the next group. Participants in each group will be confined to the study center for a total of 5 days, the total duration of each subject's participation will be up to 33 days, including the screening phase. The total duration of the study (completion of all 3 treatment cohorts) will be up-to-approximately 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Tramadol HCl 200 mg daily or placebo | Experimental | Participants will receive one capsule of Tramadol hydrochloride (HCl) every 6 hours. Participants assigned to placebo will receive matching placebo capsules. A total of 9 doses will be administered. |
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| 2: Tramadol HCl 400 mg daily or placebo | Experimental | Participants will recieve two capsules of Tramadol HCl every 6 hours. Participants assigned to placebo will receive matching placebo capsules. A total of 9 doses will be administered. |
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| 3: Tramadol HCl 600 mg daily or placebo | Experimental | Participants will receive three capsules of Tramadol HCl every 6 hours. Participants assigned to placebo will receive matching placebo capsules. A total of 9 doses will be administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol HCl, 50 mg | Drug | 50-mg overencapsulated tablet for oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in vital signs and other parameters as a measure of safety and tolerability of tramadol | Changes in clinical laboratory results, vital signs, psycopharmacologic status (Richmond Agitation-Sedation Scale (RASS), and physical examination. | Baseline, Days 1 through 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in time-matched electrocardiogram (ECG) measurements | ECG will detect abnormal changes from baseline in cardiac depolarization/repolarization. | Baseline, Day 1, Day 3 and Day 4 |
| Change from baseline in pharmacokinetic parameters of tramadol and M1 metabolite |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Scientific Affairs, LLC Clinical trial | Janssen Scientific Affairs, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Overland Park | Kansas | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D008133 | Long QT Syndrome |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Placebo | Drug | Size-matching capsules containing an appropriate inactive excipient |
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Determination of concentrations of tramadol and M1 metabolite pharmacokinetic parameters in venous plasma. |
| Baseline, up to 72 hours after the 1st dose |
| Incidence and type of adverse events | Baseline, till the end of study |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |