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ConstipationPhase 3NCT00488137

Efficacy and Safety Study of Prucalopride to Treat Chronic Constipation

A Phase 3 study testing Prucalopride in people with Constipation, run by Movetis.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation. Hypothesis: Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the treatment of patients with chronic constipation and is well tolerated in those patients Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Constipation
What is being tested?
Prucalopride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
716 participants
Where
No sites listed yet
Study dates
Mar 1998to Jul 1999
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age (no upper age limit).
  • History of constipation; the subject reports, on average, two or fewer spontaneous bowel movements per week that result in a feeling of complete evacuation and one or more of the following for at least 6 months before the selection visit:
  • very hard (little balls) and/or hard stools at least a quarter of the stools
  • sensation of incomplete evacuation following at least a quarter of the stools
  • straining at defecation at least a quarter of the time. The above criteria are only applicable for spontaneous bowel movements, i.e., not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.
  • Subjects who never have spontaneous bowel movements are considered to be constipated and are eligible for the trial.

Who cannot join

  • Subjects in whom constipation is thought to be drug-induced, or subjects using any disallowed medication.
  • Subjects suffering from endocrine disorders, metabolic disorders or neurologic disorders.
  • Subjects with a megacolon/megarectum or a diagnosis of pseudo-obstruction.
  • Constipation as a result of surgery.
  • Known or suspected organic disorders of the large bowel, i.e. obstruction, carcinoma, or inflammatory bowel disease.
  • Subjects with severe and clinically uncontrolled cardiovascular, liver, or lung disease, neurologic or psychiatric disorders (including active alcohol or drug abuse), cancer or AIDS, and other gastrointestinal or endocrine disorders.
Show all 9Show fewer
  • Subjects with impaired renal function.
  • Subjects with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
  • Females of child-bearing potential without adequate contraceptive protection during the trial.

About this study

Official title: A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride (R108512) Tablets in Subjects With Chronic Constipation

The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation.

Hypothesis:

Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the treatment of patients with chronic constipation and is well tolerated in those patients

Read the detailed description

This is a multicentre, Phase III trial with a parallel-group design, consisting of a 2 week drug-free run-in period, followed by a 12-week, double-blind, placebo-controlled treatment period.

During the run-in period, the subject's bowel habit will be documented and the existence of constipation confirmed. At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial. Subjects will be allowed to take a laxative (Dulcolax) as a rescue medication throughout the trial, but only if they have not had a bowel movement for three or more consecutive days. No Dulcolax should be taken or enemas used within 48 hours prior to the start of the double-blind treatment (48 hours prior to visit 2) and 48 hours following the start of double-blind treatment (48 hours following visit 2). Subjects will enter the double-blind period if constipation is shown to be present during the run-in period.

If the definition of constipation is not met during the 2-week run-in, the subject will be considered ineligible for the double-blind period and will be discontinued from the study.

During the double-blind, randomised, placebo-controlled period, subjects will be treated for 12 weeks with either 2 mg or 4 mg R108512 or placebo, given once daily before breakfast.

Conditions
Constipation
Being tested
Prucalopride, Placebo
Keywords
constipation, prucalopride, QOL, SCBM, PAC-SYM
Medical subject headings
Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrucaloprideDrug

    Also called Resolor

    2 mg o.d.

  • PlaceboOther

    o.d.

  • PrucaloprideDrug

    Also called Resolor

    4 mg o.d.

Study groups in NCT00488137
Study groupRoleWhat they receive
1Active comparatorPrucalopride 2 mg
Receives: Drug: Prucalopride
3Placebo comparatorPlacebo
Receives: Other: Placebo
2Active comparatorPrucalopride 4 mg
Receives: Drug: Prucalopride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects with an average of 3 or more SCBM per week

    Measured: 12 weeks

Secondary outcomes (1)

  1. Secondary efficacy variables: 1) Symptom variables 2) QOL variables

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2007 (estimated)
  2. Study startMar 1998
  3. Primary completionJul 1999
  4. Study completionJul 1999

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
716 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00488137
Sponsor's protocol ID
PRU-INT-6
Status last verified
Sep 2013
First submitted
15 Jun 2007
Last updated
26 Sep 2013
Results posted
No
Data monitoring committee
No

Publications

  • Broad J, Kung VW, Boundouki G, Aziz Q, De Maeyer JH, Knowles CH, Sanger GJ. Cholinergic interactions between donepezil and prucalopride in human colon: potential to treat severe intestinal dysmotility. Br J Pharmacol. 2013 Nov;170(6):1253-61. doi: 10.1111/bph.12397.

    PubMed 24032987

  • Lembo A, Staller K, Boules M, Feuerstadt P, Spalding W, Gabriel A, Youssef A, Xie Y, Terreri B, Cash BD. Efficacy and safety of prucalopride in patients with chronic idiopathic constipation stratified by age, body mass index, and renal function: a post hoc analysis of phase III and IV, randomized, placebo-controlled clinical studies. Ther Adv Gastroenterol. 2024 Dec 10;17:17562848241299731. doi: 10.1177/17562848241299731. eCollection 2024.

    PubMed 39664231

  • Staller K, Hinson J, Kerstens R, Spalding W, Lembo A. Efficacy of Prucalopride for Chronic Idiopathic Constipation: An Analysis of Participants With Moderate to Very Severe Abdominal Bloating. Am J Gastroenterol. 2022 Jan 1;117(1):184-188. doi: 10.14309/ajg.0000000000001521.

    PubMed 34585675

  • Tack J, Camilleri M, Dubois D, Vandeplassche L, Joseph A, Kerstens R. Association between health-related quality of life and symptoms in patients with chronic constipation: an integrated analysis of three phase 3 trials of prucalopride. Neurogastroenterol Motil. 2015 Mar;27(3):397-405. doi: 10.1111/nmo.12505. Epub 2015 Jan 11.

    PubMed 25581251

  • Tack J, Quigley E, Camilleri M, Vandeplassche L, Kerstens R. Efficacy and safety of oral prucalopride in women with chronic constipation in whom laxatives have failed: an integrated analysis. United European Gastroenterol J. 2013 Feb;1(1):48-59. doi: 10.1177/2050640612474651.

    PubMed 24917940

  • Tack J, Stanghellini V, Dubois D, Joseph A, Vandeplassche L, Kerstens R. Effect of prucalopride on symptoms of chronic constipation. Neurogastroenterol Motil. 2014 Jan;26(1):21-7. doi: 10.1111/nmo.12217. Epub 2013 Sep 20.

    PubMed 24106924

  • Tack J, van Outryve M, Beyens G, Kerstens R, Vandeplassche L. Prucalopride (Resolor) in the treatment of severe chronic constipation in patients dissatisfied with laxatives. Gut. 2009 Mar;58(3):357-65. doi: 10.1136/gut.2008.162404. Epub 2008 Nov 5.

    PubMed 18987031

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prucalopride in people with Constipation, run by Movetis.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with an average of 3 or more SCBM per week (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00488137, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2013.

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