Evaluation of Prucalopride in Male Subjects With Chronic Constipation.

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
PLACEBO	Placebo matched to Prucalopride tablet orally once daily.
PRUCALOPRIDE	Prucalopride 2 milligram (mg) tablet orally once daily for subjects greater than or equal to (≥) 18 to less than (<) 65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.

Participant Flow:   Overall Study

	PLACEBO	PRUCALOPRIDE
STARTED	187	187
COMPLETED	160	158
NOT COMPLETED	27	29
Subject Withdrew Consent	9	10
Adverse Event	7	6
Subject Non-Compliant	5	4
Principal investigator left hospital	1	3
Selection criteria not met	3	1
Lost to Follow-up	0	2
Sponsor's Decision	0	1
Lack of Efficacy	1	0
Too busy, no time for study	1	0
Went on holiday	0	1
Colonoscopy result	0	1

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Safety Population included all subjects randomized into the study and who took at least 1 dose of investigational product (n = 370).

Reporting Groups

	Description
PLACEBO	Placebo matched to Prucalopride tablet orally once daily.
PRUCALOPRIDE	Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
Total	Total of all reporting groups

Baseline Measures

	PLACEBO	PRUCALOPRIDE	Total
Overall Participants Analyzed  [Units: Participants]	186	184	370
Age  [Units: Years] Mean (Standard Deviation)	58.5  (16.28)	58.4  (17.57)	58.5  (16.91)
Age, Customized  [Units: Participants]
Less than 65 years	115	104	219
Between 65 and 75 years	39	43	82
75 years and above	32	37	69
Gender  [Units: Participants]
Female	0	0	0
Male	186	184	370
Region of Enrollment  [Units: Participants]
BELGIUM	10	10	20
BULGARIA	9	9	18
CZECH REPUBLIC	15	14	29
DENMARK	21	19	40
FRANCE	20	21	41
GERMANY	11	10	21
NETHERLANDS	5	5	10
POLAND	28	26	54
ROMANIA	57	56	113
UNITED KINGDOM	10	14	24

1.  Primary:

The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week   [ Time Frame: Over 12 week treatment period ]

2.  Secondary:

Percentage of Subjects With an Average Weekly Frequency of at Least 3 SCBM Per Week and an Increase of ≥ 1 SCBM Per Week for ≥ 75% of the 12-week Treatment Period and ≥ 75% of the Last Third of the 12-week Treatment Period   [ Time Frame: Over 12 week treatment period ]

3.  Secondary:

Percentage of Subjects With an Increase of at Least 1 SCBM Per Week   [ Time Frame: Over 12 week treatment period ]

4.  Secondary:

SCBM Per Week   [ Time Frame: Over 12 week treatment period ]

5.  Secondary:

Percent SBM With a Consistency of Normal and Hard/Very Hard   [ Time Frame: Over 12 week treatment period ]

6.  Secondary:

Percent SCBM With No Straining and Severe/Very Severe Straining   [ Time Frame: Over 12 week treatment period ]

7.  Secondary:

Percent SBM With Sensation of Complete Evacuation   [ Time Frame: Over 12 week treatment period ]

8.  Secondary:

Time to First SCBM After Investigational Product Intake on Day 1   [ Time Frame: Day 1 ]

9.  Secondary:

Bisacodyl Tablets Taken Per Week   [ Time Frame: Over 12 week treatment period ]

10.  Secondary:

Days With Rescue Medication Taken Per Week   [ Time Frame: Over 12 week treatment period ]

11.  Secondary:

Percent of Subjects With an Improvement of ≥ 1 Point on the Patient Assessment of Constipation – Symptom (PAC-SYM) Questionnaire Total Score at Final On Treatment Assessment   [ Time Frame: Over 12 week treatment period ]

12.  Secondary:

Percent of Subjects With an Improvement of ≥ 1 Point on the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Total Score at Final On Treatment Assessment   [ Time Frame: Over 12 week treatment period ]

13.  Secondary:

Percent of Subjects on the Subject Global Evaluation on Severity of Constipation Score Rating Constipation as Severe to Very Severe at Final On-Treatment Assessment   [ Time Frame: Over 12 week treatment period ]

14.  Secondary:

Percent of Subjects on the Subject Global Evaluation on Efficacy of Treatment Score Rating Treatment as Quite a Bit to Extremely Effective at Final On-Treatment Assessment   [ Time Frame: Over 12 week treatment period ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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