MedDataX Logo

A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers

NCT ID: NCT01947920

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Healthy Pain Tramadol hydrochloride Tramadol HCl Analgesic QT prolongation RWJ-26898-002

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1: Tramadol HCl 200 mg daily or placebo

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.

Group Type EXPERIMENTAL

Tramadol HCl, 50 mg

Intervention Type DRUG

50-mg overencapsulated tablet for oral administration

Placebo

Intervention Type DRUG

Size-matching capsules containing an appropriate inactive excipient

2: Tramadol HCl 400 mg daily or placebo

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.

Group Type EXPERIMENTAL

Tramadol HCl, 50 mg

Intervention Type DRUG

50-mg overencapsulated tablet for oral administration

Placebo

Intervention Type DRUG

Size-matching capsules containing an appropriate inactive excipient

3: Tramadol HCl 600 mg daily or placebo

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.

Group Type EXPERIMENTAL

Tramadol HCl, 50 mg

Intervention Type DRUG

50-mg overencapsulated tablet for oral administration

Placebo

Intervention Type DRUG

Size-matching capsules containing an appropriate inactive excipient

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tramadol HCl, 50 mg

50-mg overencapsulated tablet for oral administration

Intervention Type DRUG

Placebo

Size-matching capsules containing an appropriate inactive excipient

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role collaborator

Cipher Pharmaceuticals Inc.

INDUSTRY

Sponsor Role collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Janssen Scientific Affairs, LLC Clinical trial

Role: STUDY_DIRECTOR

Janssen Scientific Affairs, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Overland Park, Kansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TRAMPAI1002

Identifier Type: OTHER

Identifier Source: secondary_id

V01-TRAA-501

Identifier Type: OTHER

Identifier Source: secondary_id

2013-01-00

Identifier Type: OTHER

Identifier Source: secondary_id

CR102458

Identifier Type: -

Identifier Source: org_study_id