A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Tramadol HCl, 50 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01947920

CR102458

V01-TRAA-501 (Other Identifier)

TRAMPAI1002 (Other Identifier)

2013-01-00 (Other Identifier)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• body mass index between 18 and 30 kg/m², inclusive
• body weight not less than 50 kg
• have a normal electroencephalogram under basic and stimulated conditions
• have a 12-lead ECG that is consistent with normal cardiac conduction and function
• have not used any tobacco products (eg, cigarettes, cigars, chewing tobacco, gum, or patch) for at least 6 months before first study drug administration

Exclusion criteria

• any personal or family history of epileptic seizures or convulsions
• have suffered from head trauma with loss of consciousness -have suffered from central nervous system infection
• have suffered from loss of consciousness of unknown origin
• drowning or sudden infant death syndrome in a first degree relative

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups

1: Tramadol HCl 200 mg daily or placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Tramadol HCl, 50 mg

2: Tramadol HCl 400 mg daily or placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Tramadol HCl, 50 mg

3: Tramadol HCl 600 mg daily or placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Tramadol HCl, 50 mg