Effect of Methylnaltrexone on GI Transit in Healthy Volunteers

PHASE4CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

February 28, 2010

Study Completion Date

February 28, 2010

Conditions
Gastric Motility Disorder
Interventions
DRUG

Methylnaltrexone only

0.30 mg/kg subcutaneous injection daily

DRUG

Codeine only

30 mg taken orally four times daily for 5 days

DRUG

Methylnaltrexone + codeine

Methylnaltrexone 0.30 mg/kg by subcutaneous injection once daily and codeine 30 mg taken orally four times daily for 5 days

DRUG

Placebo + placebo

Placebo subcutaneous injection once daily and placebo taken orally four times daily for 5 days

Trial Locations (1)

55905

Mayo Clinic Rochester, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

lead

Mayo Clinic

OTHER

NCT01055704 - Effect of Methylnaltrexone on GI Transit in Healthy Volunteers | Biotech Hunter | Biotech Hunter