Trial Outcomes & Findings for Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years (NCT NCT01424228)

Last Updated: 2021-06-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

364 participants

Primary outcome timeframe

Over 24 week treatment period

Results posted on

2021-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Tablet once daily before breakfast	Prucalopride 1 mg or 2 mg tablet once daily before breakfast
Overall Study STARTED	182	182
Overall Study COMPLETED	126	135
Overall Study NOT COMPLETED	56	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Tablet once daily before breakfast	Prucalopride 1 mg or 2 mg tablet once daily before breakfast
Overall Study Withdrawal by Subject	27	11
Overall Study Adverse Event	10	14
Overall Study Sponsor's decision	9	12
Overall Study Lack of Efficacy	5	7
Overall Study inclusion/exclusion criteria not met	2	2
Overall Study Non-compliance	2	0
Overall Study Worsening of symptoms	1	0
Overall Study Unplanned journey	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=180 Participants Tablet once daily before breakfast	Prucalopride n=181 Participants 1 mg or 2 mg tablet once daily before breakfast	Total n=361 Participants Total of all reporting groups
Region of Enrollment Hungary	29 Participants n=5 Participants	31 Participants n=7 Participants	60 Participants n=5 Participants
Age, Continuous	48.3 years STANDARD_DEVIATION 16.25 • n=5 Participants	49.4 years STANDARD_DEVIATION 15.78 • n=7 Participants	48.9 years STANDARD_DEVIATION 16.00 • n=5 Participants
Age, Customized <65 years	149 Participants n=5 Participants	146 Participants n=7 Participants	295 Participants n=5 Participants
Age, Customized > = 65 years to <75 years	20 Participants n=5 Participants	26 Participants n=7 Participants	46 Participants n=5 Participants
Age, Customized >=75 years	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Female	153 Participants n=5 Participants	155 Participants n=7 Participants	308 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment Romania	38 Participants n=5 Participants	37 Participants n=7 Participants	75 Participants n=5 Participants
Region of Enrollment Poland	34 Participants n=5 Participants	31 Participants n=7 Participants	65 Participants n=5 Participants
Region of Enrollment Slovakia	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Region of Enrollment Italy	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment Spain	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Belgium	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Sweden	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Czech Republic	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Over 24 week treatment period

Population: Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. There were 21 subjects with a risk of potential unblinding due to an error in the randomization system who were excluded from the ITT Population to avoid the risk of bias to the study results.

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.

Outcome measures

Outcome measures
Measure	Placebo n=169 Participants Tablet once daily before breakfast	Prucalopride n=171 Participants 1 mg or 2 mg tablet once daily before breakfast
The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period	20.7 percentage of subjects	25.1 percentage of subjects

SECONDARY outcome

Timeframe: Over 24 week treatment period

Population: Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.

Outcome measures

Outcome measures
Measure	Placebo n=169 Participants Tablet once daily before breakfast	Prucalopride n=171 Participants 1 mg or 2 mg tablet once daily before breakfast
Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks	42.0 percentage of subjects	48.0 percentage of subjects

SECONDARY outcome

Timeframe: Over 24 week treatment period

Population: ITT population. Not all subjects in the ITT population had data for this outcome.

Outcome measures

Outcome measures
Measure	Placebo n=165 Participants Tablet once daily before breakfast	Prucalopride n=158 Participants 1 mg or 2 mg tablet once daily before breakfast
Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks	1.7 SCBM/week Standard Deviation 1.86	2.1 SCBM/week Standard Deviation 1.96

SECONDARY outcome

Timeframe: Baseline and Over 24 week treatment period

Population: ITT population. Not all subjects in the ITT population had data for this outcome.

Outcome measures

Outcome measures
Measure	Placebo n=165 Participants Tablet once daily before breakfast	Prucalopride n=158 Participants 1 mg or 2 mg tablet once daily before breakfast
Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks	1.3 SCBM/week Standard Deviation 1.77	1.7 SCBM/week Standard Deviation 1.90

SECONDARY outcome

Timeframe: Over 24 week treatment period

Outcome measures

Outcome measures
Measure	Placebo n=169 Participants Tablet once daily before breakfast	Prucalopride n=171 Participants 1 mg or 2 mg tablet once daily before breakfast
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 1	18.3 percentage of subjects	32.2 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 2	23.1 percentage of subjects	34.5 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 3	22.5 percentage of subjects	32.2 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 4	23.1 percentage of subjects	31.6 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 5	26.6 percentage of subjects	27.5 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 6	28.4 percentage of subjects	29.2 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 7	29.0 percentage of subjects	29.8 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 8	26.0 percentage of subjects	30.4 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 9	27.8 percentage of subjects	33.3 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 10	26.0 percentage of subjects	30.4 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 11	25.4 percentage of subjects	37.4 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 12	27.2 percentage of subjects	33.9 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 13	23.7 percentage of subjects	30.4 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 14	30.2 percentage of subjects	35.7 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 15	24.9 percentage of subjects	29.2 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 16	29.6 percentage of subjects	35.1 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 17	28.4 percentage of subjects	35.1 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 18	30.2 percentage of subjects	32.7 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 19	32.0 percentage of subjects	32.2 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 20	24.9 percentage of subjects	37.4 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 21	26.6 percentage of subjects	30.4 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 22	27.8 percentage of subjects	32.7 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 23	30.2 percentage of subjects	31.0 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week Week 24	32.0 percentage of subjects	31.6 percentage of subjects

SECONDARY outcome

Timeframe: Over 24 week treatment period

Outcome measures

Outcome measures
Measure	Placebo n=169 Participants Tablet once daily before breakfast	Prucalopride n=171 Participants 1 mg or 2 mg tablet once daily before breakfast
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period First 4-week period	18.3 percentage of subjects	26.9 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period Second 4-week period	23.7 percentage of subjects	25.7 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period Third 4-week period	23.7 percentage of subjects	29.2 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period Fourth 4-week period	22.5 percentage of subjects	29.2 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period Fifth 4-week period	23.7 percentage of subjects	33.3 percentage of subjects
Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period Sixth 4-week period	24.9 percentage of subjects	26.9 percentage of subjects

SECONDARY outcome

Timeframe: Baseline and Over 24 week treatment period

Population: ITT population. Not all subjects in the ITT population had data for this outcome.

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.

Outcome measures

Outcome measures
Measure	Placebo n=67 Participants Tablet once daily before breakfast	Prucalopride n=55 Participants 1 mg or 2 mg tablet once daily before breakfast
Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks	-0.1 units on a scale Standard Deviation 1.79	-0.1 units on a scale Standard Deviation 1.31

SECONDARY outcome

Timeframe: Baseline and Over 24 week treatment period

Population: ITT population. Not all subjects in the ITT population had data for this outcome.

Outcome measures

Outcome measures
Measure	Placebo n=67 Participants Tablet once daily before breakfast	Prucalopride n=55 Participants 1 mg or 2 mg tablet once daily before breakfast
Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks Normal consistency	16.82 percentage of SCBM Standard Deviation 42.365	25.71 percentage of SCBM Standard Deviation 40.1
Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks Hard/Very Hard consistency	-9.11 percentage of SCBM Standard Deviation 41.495	-13.82 percentage of SCBM Standard Deviation 31.349

SECONDARY outcome

Timeframe: Baseline and Over 24 week treatment period

Population: ITT population. Not all subjects in the ITT population had data for this outcome.

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

Outcome measures

Outcome measures
Measure	Placebo n=67 Participants Tablet once daily before breakfast	Prucalopride n=55 Participants 1 mg or 2 mg tablet once daily before breakfast
Change From Baseline in Straining Per SCBM at Up to 24 Weeks	-0.44 units on a scale Standard Deviation 0.948	-0.23 units on a scale Standard Deviation 0.870

SECONDARY outcome

Timeframe: Baseline and Over 24 week treatment period

Population: ITT population. Not all subjects in the ITT population had data for this outcome.

Outcome measures

Outcome measures
Measure	Placebo n=67 Participants Tablet once daily before breakfast	Prucalopride n=55 Participants 1 mg or 2 mg tablet once daily before breakfast
Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks No straining	11.14 percentage of SCBM Standard Deviation 39.786	6.61 percentage of SCBM Standard Deviation 33.916
Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks Severe/Very Severe straining	-9.85 percentage of SCBM Standard Deviation 29.711	-4.49 percentage of SCBM Standard Deviation 28.177

SECONDARY outcome

Timeframe: Baseline and Over 24 week treatment period

Population: ITT population. Not all subjects in the ITT population had data for this outcome.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Tablet once daily before breakfast	Prucalopride n=138 Participants 1 mg or 2 mg tablet once daily before breakfast
Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks	20.94 percentage of SBM Standard Deviation 32.619	24.22 percentage of SBM Standard Deviation 32.878

SECONDARY outcome

Timeframe: Day 1 and 28

Outcome measures

Outcome measures
Measure	Placebo n=169 Participants Tablet once daily before breakfast	Prucalopride n=171 Participants 1 mg or 2 mg tablet once daily before breakfast
Time to First SCBM After Investigational Product Intake on Day 1 and Day 28 Day 1	359.67 hours Interval 179.6 to 461.42	100.83 hours Interval 74.0 to 170.75
Time to First SCBM After Investigational Product Intake on Day 1 and Day 28 Day 28	100.58 hours Interval 75.2 to 199.02	81.78 hours Interval 52.25 to 151.05

SECONDARY outcome

Timeframe: Baseline and Over 24 week treatment period

Population: ITT population. Not all subjects in the ITT population had data for this outcome.

Outcome measures

Outcome measures
Measure	Placebo n=140 Participants Tablet once daily before breakfast	Prucalopride n=144 Participants 1 mg or 2 mg tablet once daily before breakfast
Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks	-0.68 tablets/week Standard Deviation 1.583	-0.97 tablets/week Standard Deviation 1.821

SECONDARY outcome

Timeframe: Baseline and Over 24 week treatment period

Population: ITT population. Not all subjects in the ITT population had data for this outcome.

Rescue medications include laxatives and enemas.

Outcome measures

Outcome measures
Measure	Placebo n=140 Participants Tablet once daily before breakfast	Prucalopride n=144 Participants 1 mg or 2 mg tablet once daily before breakfast
Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks	-0.42 days/week Standard Deviation 0.892	-0.54 days/week Standard Deviation 1.018

SECONDARY outcome

Timeframe: Baseline and Over 24 week treatment period

Population: ITT population. Not all subjects in the ITT population had data for this outcome.

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.

Outcome measures

Outcome measures
Measure	Placebo n=167 Participants Tablet once daily before breakfast	Prucalopride n=167 Participants 1 mg or 2 mg tablet once daily before breakfast
Change From Baseline in the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value	-0.68 units on a scale Standard Deviation 0.929	-0.55 units on a scale Standard Deviation 0.794

SECONDARY outcome

Timeframe: Baseline and Over 24 week treatment period

Population: ITT population. Not all subjects in the ITT population had data for this outcome.

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.

Outcome measures

Outcome measures
Measure	Placebo n=162 Participants Tablet once daily before breakfast	Prucalopride n=166 Participants 1 mg or 2 mg tablet once daily before breakfast
Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value	-0.73 units on a scale Standard Deviation 0.902	-0.67 units on a scale Standard Deviation 0.932

SECONDARY outcome

Timeframe: Baseline and Over 24 week treatment period

Population: ITT population. Not all subjects in the ITT population had data for this outcome.

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.

Outcome measures

Outcome measures
Measure	Placebo n=164 Participants Tablet once daily before breakfast	Prucalopride n=167 Participants 1 mg or 2 mg tablet once daily before breakfast
Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value Mental component	3.786 units on a scale Standard Deviation 10.0887	3.179 units on a scale Standard Deviation 10.5714
Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value Physical component	3.331 units on a scale Standard Deviation 6.9830	2.965 units on a scale Standard Deviation 6.9320

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 23 other events

Deaths: 0 deaths

Prucalopride

Serious events: 4 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=180 participants at risk Tablet once daily before breakfast	Prucalopride n=181 participants at risk 1 mg or 2 mg tablet once daily before breakfast
Gastrointestinal disorders Colitis ischemic	0.56% 1/180 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).	0.00% 0/181 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).
Gastrointestinal disorders Obstruction gastric	0.00% 0/180 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).	0.55% 1/181 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).
Hepatobiliary disorders Cholecystitis chronic	0.56% 1/180 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).	0.00% 0/181 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).
Infections and infestations Vestibular neuronitis	0.56% 1/180 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).	0.00% 0/181 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).
Investigations Blood pressure decreased	0.00% 0/180 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).	0.55% 1/181 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).
Investigations Electrocardiogram QT prolonged	0.00% 0/180 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).	0.55% 1/181 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).
Nervous system disorders Cerebrovascular accident	0.00% 0/180 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).	0.55% 1/181 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).
Nervous system disorders Ischemic stroke	0.56% 1/180 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).	0.00% 0/181 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).
Psychiatric disorders Abnormal behavior	0.00% 0/180 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).	0.55% 1/181 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).
Vascular disorders Orthostatic hypotension	0.56% 1/180 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).	0.00% 0/181 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).

Other adverse events

Other adverse events
Measure	Placebo n=180 participants at risk Tablet once daily before breakfast	Prucalopride n=181 participants at risk 1 mg or 2 mg tablet once daily before breakfast
Gastrointestinal disorders Abdominal pain	4.4% 8/180 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).	9.9% 18/181 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).
Gastrointestinal disorders Nausea	3.9% 7/180 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).	7.2% 13/181 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).
Nervous system disorders Headache	5.6% 10/180 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).	11.6% 21/181 The Safety Population includes all subjects randomized into the study who took at least 1 dose of investigational product. Three subjects did not receive investigational product and therefore were not included in the Safety Population (n = 361).

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Publication restrictions are in place

Restriction type: OTHER