Comparator Study of PEG 3350 Versus Prucalopride in Females With Chronic Constipation

PHASE3CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

September 30, 2011

Study Completion Date

December 31, 2011

Conditions
Constipation
Interventions
DRUG

PEG 3350 plus electrolytes

Each sachet of PEG 3350 is dissolved in 125 mL of water. Patients receive two sachets of PEG 3350 plus electrolytes followed by two placebo tablets for the first 14 days, after which dosage adjustment is permitted, according to effect. Each patient is treated for 28 days in total.

DRUG

Prucalopride

"Patients less than 65 years of age receive a solution containing two sachets of reconstituted placebo followed by two prucalopride 1 mg tablets for 28 days.~Patients more than 65 years of age receive a solution containing two sachets of reconstituted placebo followed by one prucalopride 1 mg tablet and one placebo tablet for 28 days."

Trial Locations (1)

RO-300244

Pierrel Research, Timișoara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Norgine

INDUSTRY