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

Phase 4

Completed

Conditions: Constipation

Interventions: Drug: placebo
Drug: prucalopride

Registration Number: NCT01424228

Lead Sponsor: Shire

Brief Summary: 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.

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 364

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo 2 mg tablet once daily before breakfast
prucalopride	prucalopride	Prucalopride 2 mg once daily before breakfast

Primary Outcome Measures

Name	Time	Method
The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period	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 Outcome Measures

Name	Time	Method
Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks	Over 24 week treatment period
Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks	Over 24 week treatment period
Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks	Baseline and Over 24 week treatment period
Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value	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.
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week	Over 24 week treatment period
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period	Over 24 week treatment period
Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks	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.
Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks	Baseline and Over 24 week treatment period
Change From Baseline in Straining Per SCBM at Up to 24 Weeks	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)
Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks	Baseline and Over 24 week treatment period
Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks	Baseline and Over 24 week treatment period
Time to First SCBM After Investigational Product Intake on Day 1 and Day 28	Day 1 and 28
Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks	Baseline and Over 24 week treatment period
Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks	Baseline and Over 24 week treatment period	Rescue medications include laxatives and enemas.
Change From Baseline in the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value	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.
Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value	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.

Trial Locations

Locations (60): Universitaire Ziekenhuizen Leuven
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Leuven, Flemish Brabant, Belgium
Cliniques Universitaires St. Luc
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Brussel, Belgium
Huisartspraktijk Jaak Mortelmans
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Ham, Belgium
Centre Hospitalier Universitaire Sart Tilman Liège
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Liège, Belgium
Fakultní Thomayerova nemocnice s poliklinikou
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Praha 4 - Krc, Praha, Czechia
Derma Plus s.r.o.
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Ceské Budejovice, Czechia
Oblastní nemocnice Kolín, a.s.
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Kolin, Czechia
Diagnostika a Lécba Zažívacích Chorob, s.r.o.
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Ostrava-Hrabuvka, Czechia
MONSE s.r.o
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Praha 1, Czechia
Nemocnice Tábor, a.s.
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Tabor, Czechia
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Universitaire Ziekenhuizen Leuven
🇧🇪Leuven, Flemish Brabant, Belgium