NCT01586494View on ClinicalTrials.gov

A Pharmacokinetic, Tolerability, and Safety Study of ULTRAM ER in Children With Pain

PHASE1CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

June 30, 2009

Study Completion Date

June 30, 2009

Conditions
Pain
Interventions
DRUG

ULTRAM ER

One dose of ULTRAM ER that is closest to 2 mg/kg, based on the participant's body weight and adjusting the dose in 25 mg increments.

DRUG

ULTRAM ER

The target dose for Group 2 will be the one that achieves a level of exposure similar to that seen with a single 200 mg ULTRAM ER dose in adults.

All Listed Sponsors
lead

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

NCT01586494 - A Pharmacokinetic, Tolerability, and Safety Study of ULTRAM ER in Children With Pain | Biotech Hunter | Biotech Hunter