A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers
Information source: Janssen Scientific Affairs, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Tramadol HCl, 50 mg (Drug); Placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Janssen Scientific Affairs, LLC Official(s) and/or principal investigator(s): Janssen Scientific Affairs, LLC Clinical trial, Study Director, Affiliation: Janssen Scientific Affairs, LLC
Summary
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).
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics Following Multiple Ascending Doses of Tramadol Hydrochloride in Healthy Male and Female Subjects
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change from baseline in vital signs and other parameters as a measure of safety and tolerability of tramadol
Secondary outcome: Change from baseline in time-matched electrocardiogram (ECG) measurementsChange from baseline in pharmacokinetic parameters of tramadol and M1 metabolite Incidence and type of adverse events
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Overland Park, Kansas, United States
Additional Information
Starting date: August 2013
Last updated: December 15, 2014
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