A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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).

Key facts

Study ID

NCT01947920

Run by

Janssen Scientific Affairs, LLC

People needed

30

Starts

2013-08-01

Expected to finish

2013-11-01

Last updated by the study team

2014-12-16

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.