Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years (SPD555-401)
The purpose of this trial is to evaluate the long-term (24 weeks) efficacy of prucalopride versus placebo in subjects aged 18 years and older with chronic constipation.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Long-term Treatment (24 Weeks) With Prucalopride in Subjects Aged ≥18 Years With Chronic Constipation|
- As a measure of efficacy: the primary endpoint is defined as the proportion (%) of subjects with an average of ≥3 SCBM /week evaluated over the 24-week treatment phase [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To evaluate the long-term efficacy of prucalopride versus placebo in subjects aged 18 years old and older with chronic constipation. Information will be obtained by:
- Electronic diary data (e-diary)
- Subject's global assessments
- Subject's symptom assessments
- Safety and tolerability [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Evaluation of long-term safety parameters by measuring:
- Adverse events
- Vital signs and ECG
- Physical examination.
- Laboratory assessments and pregnancy tests
- Quality of Life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Quality of Life will be evaluated using:
|Study Start Date:||June 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo 2 mg tablet once daily before breakfast
Placebo matching tablet 2 mg once daily before breakfast for 24 weeks
Active Comparator: prucalopride
Prucalopride 2 mg once daily before breakfast
Prucalopride 2 mg daily before breakfast
1 mg for subjects >65 years; in case of insufficient response 2 mg at week 2 or week 4
In this phase IV trial a total of 340 subjects (170 subjects per treatment group), with chronic constipation, are planned to be randomly assigned to double-blind treatment.
The trial duration for a subject can be 26 to 28 weeks in total, including a 2- to 4-week run-in phase followed by a 24-week double-blind treatment phase. The patient will complete an e-diary.
Adult subjects (≥18 to <65 years of age) will take 2 mg prucalopride or matching placebo throughout the entire 24-week treatment period. Elderly subjects (≥65 years of age) will start at a dose of 1 mg prucalopride or matching placebo. In case of insufficient response the daily dose has to be increased to 2 mg (i.e. changed to 2 mg prucalopride or matching placebo).
Show 60 Study Locations