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Completed

NCT Number: NCT01424228

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

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universitaire Ziekenhuizen Leuven, Leuven, Flemish Brabant, Belgium

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is a male or non-pregnant, non-breastfeeding female out-patient ≥18 years of age (no upper age limit).
  • Subject has a history of constipation. The subject reports an average of ≤2 SBM/week that result in a feeling of complete evacuation (SCBM).
  • 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

  • Subjects in whom constipation is thought to be drug-induced
  • Subjects using any disallowed medication.
  • Subjects who previously used prucalopride.
  • Subjects suffering from secondary causes of chronic constipation.

Treatment and study plan

Placebo

Drug

Placebo matching tablet 2 mg once daily before breakfast for 24 weeks

prucalopride

Drug

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

Primary outcomes

  1. The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period

    Time frame: Over 24 week treatment period

    Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.

Secondary outcomes

  1. Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks

    Time frame: Over 24 week treatment period

  2. Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks

    Time frame: Over 24 week treatment period

  3. Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks

    Time frame: Baseline and Over 24 week treatment period

  4. Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week

    Time frame: Over 24 week treatment period

  5. Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period

    Time frame: Over 24 week treatment period

  6. Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks

    Time frame: Baseline and Over 24 week treatment period

    Consistency measured using the 7-point Bristol scale where 1-2 indicate constipation (=hard/very hard), 3-4 are ideal stools (=normal), and 5-7 tending toward diarrhea.

  7. Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks

    Time frame: Baseline and Over 24 week treatment period

  8. Change From Baseline in Straining Per SCBM at Up to 24 Weeks

    Time frame: Baseline and Over 24 week treatment period

    Straining was evaluated on a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, or 4=very severe)

  9. Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks

    Time frame: Baseline and Over 24 week treatment period

  10. Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks

    Time frame: Baseline and Over 24 week treatment period

  11. Time to First SCBM After Investigational Product Intake on Day 1 and Day 28

    Time frame: Day 1 and 28

  12. Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks

    Time frame: Baseline and Over 24 week treatment period

  13. Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks

    Time frame: Baseline and Over 24 week treatment period

    Rescue medications include laxatives and enemas.

  14. Change From Baseline in the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value

    Time frame: Baseline and Over 24 week treatment period

    The PAC-SYM is a validated 12-item questionnaire for the evaluation of severity of symptoms of constipation in subjects with constipation. Items are rated on a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. Total score ranges from 0 to 48. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-SYM total score was considered clinically meaningful.

  15. Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value

    Time frame: Baseline and Over 24 week treatment period

    The PAC-QOL is a validated 28-item questionnaire for the evaluation of quality of life in subjects with constipation. Items are rated on a 5-point Likert scale: 0=not at all/none of the time, 1=a little bit/a little bit of the time, 2=moderately/some of the time, 3=quite a bit/most of the time, 4=extremely/all of the time. Total score ranges from 0-112. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-QOL total score was considered clinically meaningful.

  16. Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value

    Time frame: Baseline and Over 24 week treatment period

    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Acronym: SPD555-401

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 26, 2011
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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