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Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years (SPD555-401)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Movetis
ClinicalTrials.gov Identifier:
NCT01424228
First received: August 25, 2011
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Constipation
 Drug: placebo
Drug: prucalopride
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by Movetis:

Primary Outcome Measures:
  • 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:

    1. Electronic diary data (e-diary)
    2. Subject's global assessments
    3. Subject's symptom assessments


Secondary Outcome Measures:
  • 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:

    • PAC-QOL
    • SF-36.


Enrollment: 364
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo 2 mg tablet once daily before breakfast
 Drug: placebo
Placebo matching tablet 2 mg once daily before breakfast for 24 weeks
Active Comparator: prucalopride
Prucalopride 2 mg once daily before breakfast
 Drug: prucalopride

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

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is a male or non-pregnant, non-breastfeeding female out-patient ≥18 years of age (no upper age limit).
  2. Subject has a history of constipation. The subject reports an average of ≤2 SBM/week that result in a feeling of complete evacuation (SCBM).
  3. Subject agrees to stop his/her current laxative treatment and is willing to use rescue medication according to the rescue rule [bisacodyl/enemas].

Exclusion Criteria:

  1. Subjects in whom constipation is thought to be drug-induced
  2. Subjects using any disallowed medication.
  3. Subjects who previously used prucalopride.
  4. Subjects suffering from secondary causes of chronic constipation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424228

  Show 60 Study Locations
Sponsors and Collaborators
Movetis
  More Information

No publications provided

Responsible Party: Movetis
ClinicalTrials.gov Identifier: NCT01424228     History of Changes
Other Study ID Numbers: M0001-C401
Study First Received: August 25, 2011
Last Updated: April 25, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: CEBK
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency

Keywords provided by Movetis:
Long term
Constipation
Digestive signs and symptoms

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013