Trial Outcomes & Findings for Dulcolax vs Placebo in Functional Constipation (NCT NCT00526097)

NCT ID: NCT00526097

Last Updated: 2014-01-15

Results Overview

A Complete Spontaneous Bowel Movement (CSBM) is a complete non-rescue medication-induced stool. The number of CSBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 368 participants
• Primary outcome timeframe: 4 Weeks
• Results posted on: 2014-01-15

Participant Flow

Participants were partly recruited by commercial research centers and partly by general practitioners.

Participants were randomised into the treatment period only, when functional constipation and compliance with rescue medication were confirmed by eDiary data in the two-weeks baseline period without study medication.

Participant milestones

Measure	Placebo Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl Two bisacodyl 5 mg tablets once daily
Overall Study STARTED	121	247
Overall Study COMPLETED	106	191
Overall Study NOT COMPLETED	15	56

Reasons for withdrawal

Measure	Placebo Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl Two bisacodyl 5 mg tablets once daily
Overall Study Adverse Event	6	44
Overall Study Protocol Violation	4	10
Overall Study Withdrawal by Subject	3	1
Overall Study Other	2	1

Baseline Characteristics

Dulcolax vs Placebo in Functional Constipation

Baseline characteristics by cohort

Measure	Placebo n=121 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=247 Participants Two bisacodyl 5 mg tablets once daily	Total n=368 Participants Total of all reporting groups
Age, Continuous	54.7 Years STANDARD_DEVIATION 15.1 • n=5 Participants	55.8 Years STANDARD_DEVIATION 15.9 • n=7 Participants	55.4 Years STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants	179 Participants n=7 Participants	275 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	68 Participants n=7 Participants	93 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with abdominal bloating Not at all bothersome	12 Participants n=5 Participants	21 Participants n=7 Participants	33 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with abdominal bloating Hardly bothersome	20 Participants n=5 Participants	33 Participants n=7 Participants	53 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with abdominal bloating Moderately bothersome	40 Participants n=5 Participants	85 Participants n=7 Participants	125 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with abdominal bloating A good deal bothersome	36 Participants n=5 Participants	60 Participants n=7 Participants	96 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with abdominal bloating A very great deal bothersome	12 Participants n=5 Participants	47 Participants n=7 Participants	59 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with abdominal bloating Missing assessment	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with abdominal discomfort Not at all bothersome	14 Participants n=5 Participants	26 Participants n=7 Participants	40 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with abdominal discomfort Hardly bothersome	22 Participants n=5 Participants	40 Participants n=7 Participants	62 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with abdominal discomfort Moderately bothersome	47 Participants n=5 Participants	91 Participants n=7 Participants	138 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with abdominal discomfort A good deal bothersome	31 Participants n=5 Participants	64 Participants n=7 Participants	95 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with abdominal discomfort A very great deal bothersome	6 Participants n=5 Participants	25 Participants n=7 Participants	31 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with abdominal discomfort Missing assessment	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with constipation Not at all bothersome	6 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with constipation Hardly bothersome	5 Participants n=5 Participants	19 Participants n=7 Participants	24 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with constipation Moderately bothersome	57 Participants n=5 Participants	91 Participants n=7 Participants	148 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with constipation A good deal bothersome	41 Participants n=5 Participants	88 Participants n=7 Participants	129 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with constipation A very great deal bothersome	11 Participants n=5 Participants	33 Participants n=7 Participants	44 Participants n=5 Participants
Baseline assessment regarding the bothersomeness with constipation Missing assessment	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Baseline assessment regarding the overall satisfaction with bowel habits A very great deal satisfied	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Baseline assessment regarding the overall satisfaction with bowel habits A good deal satisfied	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Baseline assessment regarding the overall satisfaction with bowel habits Moderately satisfied	41 Participants n=5 Participants	74 Participants n=7 Participants	115 Participants n=5 Participants
Baseline assessment regarding the overall satisfaction with bowel habits Hardly satisfied	44 Participants n=5 Participants	93 Participants n=7 Participants	137 Participants n=5 Participants
Baseline assessment regarding the overall satisfaction with bowel habits Not at all satisfied	29 Participants n=5 Participants	60 Participants n=7 Participants	89 Participants n=5 Participants
Baseline assessment regarding the overall satisfaction with bowel habits Missing assessment	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Baseline for dimension 'Bodily pain (BP)' of the SF-36 QoL scale	68.5 Score on a scale STANDARD_DEVIATION 24.3 • n=5 Participants	67.5 Score on a scale STANDARD_DEVIATION 26.0 • n=7 Participants	67.8 Score on a scale STANDARD_DEVIATION 25.4 • n=5 Participants
Baseline for dimension 'General health (GH)' of the SF-36 QoL scale	68.0 Score on a scale STANDARD_DEVIATION 21.1 • n=5 Participants	69.9 Score on a scale STANDARD_DEVIATION 20.6 • n=7 Participants	69.3 Score on a scale STANDARD_DEVIATION 20.7 • n=5 Participants
Baseline for dimension 'Mental health (MH)' of the SF-36 QoL scale	74.2 Score on a scale STANDARD_DEVIATION 18.0 • n=5 Participants	77.0 Score on a scale STANDARD_DEVIATION 16.8 • n=7 Participants	76.1 Score on a scale STANDARD_DEVIATION 17.2 • n=5 Participants
Baseline for dimension 'Physical functioning (PF)' of the SF-36v2™ (SF-36) Quality of Life (QoL)	79.2 Score on a scale STANDARD_DEVIATION 24.3 • n=5 Participants	80.1 Score on a scale STANDARD_DEVIATION 24.6 • n=7 Participants	79.8 Score on a scale STANDARD_DEVIATION 24.5 • n=5 Participants
Baseline for dimension 'Role limitation due to emotional problems (RE)' of the SF-36 QoL scale	82.7 Score on a scale STANDARD_DEVIATION 24.7 • n=5 Participants	86.3 Score on a scale STANDARD_DEVIATION 22.3 • n=7 Participants	85.1 Score on a scale STANDARD_DEVIATION 23.1 • n=5 Participants
Baseline for dimension 'Role limitation due to physical problems (RP)' of the SF-36 QoL scale	79.7 Score on a scale STANDARD_DEVIATION 25.2 • n=5 Participants	80.6 Score on a scale STANDARD_DEVIATION 25.6 • n=7 Participants	80.3 Score on a scale STANDARD_DEVIATION 25.5 • n=5 Participants
Baseline for dimension 'Social functioning (SF)' of the SF-36 QoL scale	83.4 Score on a scale STANDARD_DEVIATION 21.6 • n=5 Participants	86.0 Score on a scale STANDARD_DEVIATION 20.9 • n=7 Participants	85.1 Score on a scale STANDARD_DEVIATION 21.2 • n=5 Participants
Baseline for dimension 'Vitality (VT)' of the SF-36 QoL scale	55.7 Score on a scale STANDARD_DEVIATION 20.2 • n=5 Participants	58.9 Score on a scale STANDARD_DEVIATION 21.0 • n=7 Participants	57.9 Score on a scale STANDARD_DEVIATION 20.8 • n=5 Participants
Baseline for the Mental Component Scale (MCS) of the SF-36 QoL scale	49.0 Score on a scale STANDARD_DEVIATION 11.0 • n=5 Participants	51.1 Score on a scale STANDARD_DEVIATION 9.8 • n=7 Participants	50.4 Score on a scale STANDARD_DEVIATION 10.3 • n=5 Participants
Baseline for the Physical Component Scale (PCS) of the SF-36 QoL scale	48.7 Score on a scale STANDARD_DEVIATION 9.4 • n=5 Participants	48.3 Score on a scale STANDARD_DEVIATION 9.8 • n=7 Participants	48.5 Score on a scale STANDARD_DEVIATION 9.7 • n=5 Participants
Baseline mean score for constipation symptom 'Sensation of incomplete evacuation'	0.7 Score on a scale STANDARD_DEVIATION 0.3 • n=5 Participants	0.7 Score on a scale STANDARD_DEVIATION 0.3 • n=7 Participants	0.7 Score on a scale STANDARD_DEVIATION 0.3 • n=5 Participants
Baseline mean score for constipation symptom 'Manual manoeuvre'	0.2 Score on a scale STANDARD_DEVIATION 0.4 • n=5 Participants	0.2 Score on a scale STANDARD_DEVIATION 0.3 • n=7 Participants	0.2 Score on a scale STANDARD_DEVIATION 0.3 • n=5 Participants
Baseline mean score for constipation symptom 'Anorectal obstructions/blockade'	1.2 Score on a scale STANDARD_DEVIATION 1.0 • n=5 Participants	1.2 Score on a scale STANDARD_DEVIATION 1.0 • n=7 Participants	1.2 Score on a scale STANDARD_DEVIATION 1.0 • n=5 Participants
Baseline mean score for constipation symptom 'Stool quality'	2.4 Score on a scale STANDARD_DEVIATION 1.2 • n=5 Participants	2.5 Score on a scale STANDARD_DEVIATION 1.3 • n=7 Participants	2.4 Score on a scale STANDARD_DEVIATION 1.3 • n=5 Participants
Baseline mean score for constipation symptom 'Straining'	1.9 Score on a scale STANDARD_DEVIATION 0.9 • n=5 Participants	1.8 Score on a scale STANDARD_DEVIATION 0.8 • n=7 Participants	1.9 Score on a scale STANDARD_DEVIATION 0.8 • n=5 Participants
Baseline number of Complete Spontaneous Bowel Movements (CSBMs)	1.0 CSBMs per week STANDARD_DEVIATION 1.1 • n=5 Participants	1.1 CSBMs per week STANDARD_DEVIATION 1.2 • n=7 Participants	1.1 CSBMs per week STANDARD_DEVIATION 1.2 • n=5 Participants
Baseline number of Spontaneous Bowel Movements (SBMs)	4.2 SBMs per week STANDARD_DEVIATION 2.6 • n=5 Participants	4.4 SBMs per week STANDARD_DEVIATION 3.9 • n=7 Participants	4.3 SBMs per week STANDARD_DEVIATION 3.6 • n=5 Participants
Baseline overall score (OSC) of PAC-QoL	1.8 Score on a scale STANDARD_DEVIATION 0.6 • n=5 Participants	1.8 Score on a scale STANDARD_DEVIATION 0.7 • n=7 Participants	1.8 Score on a scale STANDARD_DEVIATION 0.7 • n=5 Participants
Baseline subscore 'Physical discomfort (PHD)' of PAC-QoL	1.9 Score on a scale STANDARD_DEVIATION 0.8 • n=5 Participants	2.0 Score on a scale STANDARD_DEVIATION 0.9 • n=7 Participants	2.0 Score on a scale STANDARD_DEVIATION 0.9 • n=5 Participants
Baseline subscore 'Psychosocial discomfort (PSD)' of PAC-QoL	0.8 Score on a scale STANDARD_DEVIATION 0.8 • n=5 Participants	0.9 Score on a scale STANDARD_DEVIATION 0.8 • n=7 Participants	0.9 Score on a scale STANDARD_DEVIATION 0.8 • n=5 Participants
Baseline subscore 'Satisfaction (SAT)' of PAC-QoL	3.0 Score on a scale STANDARD_DEVIATION 0.7 • n=5 Participants	2.8 Score on a scale STANDARD_DEVIATION 0.8 • n=7 Participants	2.9 Score on a scale STANDARD_DEVIATION 0.8 • n=5 Participants
Baseline subscore'Worries and concerns (WCC)' of Patient Assessment of Constipation-QoL(PAC-QoL)	1.4 Score on a scale STANDARD_DEVIATION 0.8 • n=5 Participants	1.5 Score on a scale STANDARD_DEVIATION 0.9 • n=7 Participants	1.4 Score on a scale STANDARD_DEVIATION 0.9 • n=5 Participants
Baseline value for chloride (normalized value)	104.0 mmol/L STANDARD_DEVIATION 2.33 • n=5 Participants	103.7 mmol/L STANDARD_DEVIATION 2.85 • n=7 Participants	103.8 mmol/L STANDARD_DEVIATION 2.69 • n=5 Participants
Baseline value for potassium (normalized value)	4.2 mmol/L STANDARD_DEVIATION 0.33 • n=5 Participants	4.2 mmol/L STANDARD_DEVIATION 0.33 • n=7 Participants	4.2 mmol/L STANDARD_DEVIATION 0.33 • n=5 Participants
Baseline value for sodium (normalized value)	139.5 mmol/L STANDARD_DEVIATION 2.13 • n=5 Participants	139.3 mmol/L STANDARD_DEVIATION 2.30 • n=7 Participants	139.4 mmol/L STANDARD_DEVIATION 2.24 • n=5 Participants

PRIMARY outcome

Timeframe: 4 Weeks

Population: Full Analysis Set (FAS): All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure

A Complete Spontaneous Bowel Movement (CSBM) is a complete non-rescue medication-induced stool.

The number of CSBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data.

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period	1.9 CSBMs per week Standard Error 0.34	5.2 CSBMs per week Standard Error 0.27

SECONDARY outcome

Timeframe: Week 1 in treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The number of CSBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Number of CSBMs at Week 1	2.0 CSBMs per week Standard Error 0.40	6.3 CSBMs per week Standard Error 0.32

SECONDARY outcome

Timeframe: Week 2 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The number of CSBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.

Outcome measures

Measure	Placebo n=115 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=229 Participants Two bisacodyl 5 mg tablets once daily
Number of CSBMs at Week 2	1.4 CSBMs per week Standard Error 0.41	4.9 CSBMs per week Standard Error 0.33

SECONDARY outcome

Timeframe: Week 3 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The number of CSBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.

Outcome measures

Measure	Placebo n=113 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=213 Participants Two bisacodyl 5 mg tablets once daily
Number of CSBMs at Week 3	1.8 CSBMs per week Standard Error 0.38	4.6 CSBMs per week Standard Error 0.32

SECONDARY outcome

Timeframe: Week 4 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The number of CSBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.

Outcome measures

Measure	Placebo n=105 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=196 Participants Two bisacodyl 5 mg tablets once daily
Number of CSBMs at Week 4	1.7 CSBMs per week Standard Error 0.42	4.3 CSBMs per week Standard Error 0.35

SECONDARY outcome

Timeframe: 4 Weeks

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

A Spontaneous Bowel Movement (SBM) is a non-rescue medication-induced stool. The number of SBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data.

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period	5.1 SBMs per week Standard Error 0.41	10.0 SBMs per week Standard Error 0.33

SECONDARY outcome

Timeframe: Week 1 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The number of SBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Number of SBMs at Week 1	5.3 SBMs per week Standard Error 0.46	12.1 SBMs per week Standard Error 0.37

SECONDARY outcome

Timeframe: Week 2 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The number of SBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.

Outcome measures

Measure	Placebo n=115 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=229 Participants Two bisacodyl 5 mg tablets once daily
Number of SBMs at Week 2	4.9 SBMs per week Standard Error 0.44	9.6 SBMs per week Standard Error 0.36

SECONDARY outcome

Timeframe: Week 3 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The number of SBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.

Outcome measures

Measure	Placebo n=113 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=213 Participants Two bisacodyl 5 mg tablets once daily
Number of SBMs at Week 3	4.8 SBMs per week Standard Error 0.44	8.6 SBMs per week Standard Error 0.36

SECONDARY outcome

Timeframe: Week 4 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The number of SBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.

Outcome measures

Measure	Placebo n=105 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=196 Participants Two bisacodyl 5 mg tablets once daily
Number of SBMs at Week 4	4.0 SBMs per week Standard Error 0.42	7.8 SBMs per week Standard Error 0.36

SECONDARY outcome

Timeframe: Time of first dose of SM up to 4 weeks

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The time to the first SBM following the first dose of SM was captured by the eDiary. The time was censored by the time of intake of rescue medication (RM), the time of premature discontinuation or the end of treatment whatever was minimal.

Outcome measures

Measure	Placebo n=114 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=235 Participants Two bisacodyl 5 mg tablets once daily
Time to the First SBM Following the First Dose of Study Medication (SM)	19 Hours Interval 16.0 to 25.0	12 Hours Interval 11.0 to 12.0

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With an Increase of at Least 1 in the Mean Number of CSBMs Per Week Over the 4 Weeks Treatment Period Compared to Baseline	47 Participants	196 Participants

SECONDARY outcome

Timeframe: Baseline and week 1 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With an Increase of at Least 1 CSBM at Week 1 Compared to Baseline	57 Participants	204 Participants

SECONDARY outcome

Timeframe: Baseline and week 2 in treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=115 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=229 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With an Increase of at Least 1 CSBM at Week 2 Compared to Baseline	43 Participants	178 Participants

SECONDARY outcome

Timeframe: Baseline and week 3 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=113 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=213 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With an Increase of at Least 1 CSBM at Week 3 Compared to Baseline	51 Participants	163 Participants

SECONDARY outcome

Timeframe: Baseline and week 4 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=105 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=196 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With an Increase of at Least 1 CSBM at Week 4 Compared to Baseline	52 Participants	148 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period	2 Participants	70 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period	32 Participants	161 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Number of Premature Withdrawals Over the 4 Weeks Treatment Period	10 Participants	51 Participants

SECONDARY outcome

Timeframe: Week 1 in the treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Number of Premature Withdrawals at Week 1 in the Treatment Period	3 Participants	25 Participants

SECONDARY outcome

Timeframe: Week 2 in the treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=115 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=229 Participants Two bisacodyl 5 mg tablets once daily
Number of Premature Withdrawals at Week 2 in the Treatment Period	3 Participants	11 Participants

SECONDARY outcome

Timeframe: Week 3 in the treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=113 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=214 Participants Two bisacodyl 5 mg tablets once daily
Number of Premature Withdrawals at Week 3 in the Treatment Period	4 Participants	9 Participants

SECONDARY outcome

Timeframe: Week 4 in the treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=105 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=196 Participants Two bisacodyl 5 mg tablets once daily
Number of Premature Withdrawals at Week 4 in the Treatment Period	0 Participants	6 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period	21 Participants	8 Participants

SECONDARY outcome

Timeframe: Week 1 in the treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants Using Rescue Medication at Week 1 in the Treatment Period	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 2 in the treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=115 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=229 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants Using Rescue Medication at Week 2 in the Treatment Period	10 Participants	4 Participants

SECONDARY outcome

Timeframe: Week 3 in the treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=113 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=213 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants Using Rescue Medication at Week 3 in the Treatment Period	9 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 4 in the treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Outcome measures

Measure	Placebo n=105 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=196 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants Using Rescue Medication at Week 4 in the Treatment Period	12 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline and week 1 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=105 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=222 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1	-0.3 Score on a scale Standard Error 0.08	-1.3 Score on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline and week 2 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=105 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=204 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2	-0.1 Score on a scale Standard Error 0.09	-1.1 Score on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline and week 3 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=100 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=190 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3	-0.3 Score on a scale Standard Error 0.09	-1.3 Score on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline and week 4 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=96 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=178 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4	-0.5 Score on a scale Standard Error 0.10	-1.2 Score on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline and week 1 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=105 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=222 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1	0.4 Score on a scale Standard Error 0.13	3.0 Score on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: Baseline and week 2 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=105 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=204 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2	0.2 Score on a scale Standard Error 0.15	2.7 Score on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline and week 3 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=100 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=190 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3	0.5 Score on a scale Standard Error 0.14	2.8 Score on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline and week 4 in treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=96 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=178 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4	0.6 Score on a scale Standard Error 0.16	2.6 Score on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: Baseline and week 1 in treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=115 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=232 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 1	-0.0 Score on a scale Standard Error 0.05	-0.2 Score on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Baseline and week 2 in treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=113 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=220 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 2	-0.0 Score on a scale Standard Error 0.05	-0.2 Score on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Baseline and week 3 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=107 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=201 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 3	-0.1 Score on a scale Standard Error 0.05	-0.2 Score on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Baseline and week 4 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=104 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=188 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 4	-0.1 Score on a scale Standard Error 0.06	-0.2 Score on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline and week 1 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=105 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=222 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 1	-0.1 Score on a scale Standard Error 0.08	-0.9 Score on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline and week 2 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=105 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=204 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 2	-0.1 Score on a scale Standard Error 0.09	-0.9 Score on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline and week 3 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=100 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=190 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 3	-0.1 Score on a scale Standard Error 0.08	-0.9 Score on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline and week 4 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=96 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=178 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 4	-0.1 Score on a scale Standard Error 0.09	-0.8 Score on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline and week 1 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=105 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=222 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 1	-0.0 Score on a scale Standard Error 0.03	-0.2 Score on a scale Standard Error 0.03

SECONDARY outcome

Timeframe: Baseline and week 2 in treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=105 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=204 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 2	0.0 Score on a scale Standard Error 0.04	-0.2 Score on a scale Standard Error 0.03

SECONDARY outcome

Timeframe: Baseline and week 3 in treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=100 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=190 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 3	-0.0 Score on a scale Standard Error 0.03	-0.2 Score on a scale Standard Error 0.03

SECONDARY outcome

Timeframe: Baseline and week 4 in treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.

Outcome measures

Measure	Placebo n=96 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=178 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 4	-0.1 Score on a scale Standard Error 0.04	-0.2 Score on a scale Standard Error 0.03

SECONDARY outcome

Timeframe: Baseline and week 1 in the treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline

Outcome measures

Measure	Placebo n=112 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=224 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline Improved overall satisfaction	44 Participants	153 Participants
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline Unchanged overall satisfaction	46 Participants	45 Participants
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline Worsened overall satisfaction	22 Participants	26 Participants

SECONDARY outcome

Timeframe: Baseline and week 2 in the treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline

Outcome measures

Measure	Placebo n=111 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=212 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline Improved overall satisfaction	41 Participants	163 Participants
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline Unchanged overall satisfaction	48 Participants	37 Participants
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline Worsened overall satisfaction	22 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline and week 3 in the treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline

Outcome measures

Measure	Placebo n=104 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=195 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline Improved overall satisfaction	44 Participants	153 Participants
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline Unchanged overall satisfaction	43 Participants	31 Participants
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline Worsened overall satisfaction	17 Participants	11 Participants

SECONDARY outcome

Timeframe: Baseline and week 4 in the treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline

Outcome measures

Measure	Placebo n=98 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=175 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline Improved overall satisfaction	37 Participants	135 Participants
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline Unchanged overall satisfaction	47 Participants	32 Participants
Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline Worsened overall satisfaction	14 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline and week 1 in the treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline

Outcome measures

Measure	Placebo n=112 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=224 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline Reduced bothersomeness	36 Participants	168 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline Unchanged bothersomeness	51 Participants	46 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline Increased bothersomeness	25 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline and week 2 in the treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline

Outcome measures

Measure	Placebo n=111 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=212 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline Reduced bothersomeness	35 Participants	160 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline Unchanged bothersomeness	45 Participants	36 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline Increased bothersomeness	31 Participants	16 Participants

SECONDARY outcome

Timeframe: Baseline and week 3 in the treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline

Outcome measures

Measure	Placebo n=104 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=195 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline Reduced bothersomeness	39 Participants	147 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline Unchanged bothersomeness	41 Participants	30 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline Increased bothersomeness	24 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline and week 4 in the treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline

Outcome measures

Measure	Placebo n=98 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=175 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline Reduced bothersomeness	30 Participants	125 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline Unchanged bothersomeness	47 Participants	35 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline Increased bothersomeness	21 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline and week 1 in the treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline

Outcome measures

Measure	Placebo n=112 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=224 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline Reduced bothersomeness	33 Participants	136 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline Unchanged bothersomeness	47 Participants	59 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline Increased bothersomeness	32 Participants	29 Participants

SECONDARY outcome

Timeframe: Baseline and week 2 in the treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline

Outcome measures

Measure	Placebo n=111 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=212 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline Reduced bothersomeness	31 Participants	142 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline Unchanged bothersomeness	46 Participants	43 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline Increased bothersomeness	34 Participants	27 Participants

SECONDARY outcome

Timeframe: Baseline and week 3 in the treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline

Outcome measures

Measure	Placebo n=104 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=195 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline Reduced bothersomeness	27 Participants	129 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline Unchanged bothersomeness	45 Participants	49 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline Increased bothersomeness	32 Participants	17 Participants

SECONDARY outcome

Timeframe: Baseline and week 4 in the treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline

Outcome measures

Measure	Placebo n=98 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=175 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline Reduced bothersomeness	25 Participants	107 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline Unchanged bothersomeness	46 Participants	49 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline Increased bothersomeness	27 Participants	19 Participants

SECONDARY outcome

Timeframe: Baseline and week 1 in the treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline

Outcome measures

Measure	Placebo n=112 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=224 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline Reduced bothersomeness	37 Participants	93 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline Unchanged bothersomeness	46 Participants	62 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline Increased bothersomeness	29 Participants	69 Participants

SECONDARY outcome

Timeframe: Baseline and week 2 in the treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline

Outcome measures

Measure	Placebo n=111 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=212 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline Reduced bothersomeness	29 Participants	104 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline Unchanged bothersomeness	49 Participants	67 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline Increased bothersomeness	33 Participants	41 Participants

SECONDARY outcome

Timeframe: Baseline and week 3 in the treatment period

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline

Outcome measures

Measure	Placebo n=104 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=195 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline Reduced bothersomeness	34 Participants	101 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline Unchanged bothersomeness	33 Participants	63 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline Increased bothersomeness	37 Participants	31 Participants

SECONDARY outcome

Timeframe: Baseline and week 4 in the treatment period

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline

Outcome measures

Measure	Placebo n=98 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=175 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline Reduced bothersomeness	31 Participants	97 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline Unchanged bothersomeness	36 Participants	46 Participants
Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline Increased bothersomeness	31 Participants	32 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Final global assessment scale range: 1 (good) to 4 (bad), ordinal

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator Good	26 Participants	156 Participants
Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator Satisfactory	37 Participants	59 Participants
Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator Not satisfactory	30 Participants	18 Participants
Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator Bad	24 Participants	6 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

Final global assessment scale range: 1 (good) to 4 (bad), ordinal

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient Good	23 Participants	132 Participants
Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient Satisfactory	35 Participants	58 Participants
Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient Not satisfactory	40 Participants	27 Participants
Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient Bad	19 Participants	22 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure

Final global assessment scale range: 1 (good) to 4 (bad), ordinal

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator Good	75 Participants	85 Participants
Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator Satisfactory	31 Participants	84 Participants
Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator Not satisfactory	10 Participants	43 Participants
Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator Bad	1 Participants	27 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure

Final global assessment scale range: 1 (good) to 4 (bad), ordinal

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient Good	38 Participants	125 Participants
Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient Satisfactory	50 Participants	65 Participants
Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient Not satisfactory	19 Participants	22 Participants
Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient Bad	10 Participants	27 Participants

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The dimension is a sum of 10 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the SF-36 Dimension 'Physical Functioning'	-0.6 Score on a scale Standard Error 1.92	-0.0 Score on a scale Standard Error 1.55

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Physical Problems'	-0.2 Score on a scale Standard Error 1.96	0.9 Score on a scale Standard Error 1.58

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the SF-36 Dimension 'Bodily Pain'	-2.3 Score on a scale Standard Error 2.21	-0.2 Score on a scale Standard Error 1.78

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the SF-36 Dimension 'General Health'	-1.3 Score on a scale Standard Error 1.28	0.7 Score on a scale Standard Error 1.03

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the SF-36 Dimension 'Vitality'	-1.6 Score on a scale Standard Error 1.66	2.7 Score on a scale Standard Error 1.34

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the SF-36 Dimension 'Social Functioning'	-2.6 Score on a scale Standard Error 2.04	-1.5 Score on a scale Standard Error 1.64

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The dimension is a sum of 3 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Emotional Problems'	-0.5 Score on a scale Standard Error 1.85	0.1 Score on a scale Standard Error 1.49

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the SF-36 Dimension 'Mental Health'	-2.9 Score on a scale Standard Error 1.52	0.6 Score on a scale Standard Error 1.22

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The MCS is a summary scale of the dimensions vitality, social functioning, role-emotional, and mental health. The component scale is norm-based to a standard population. A higher score indicates a better health.

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the SF-36 Mental Component Scale (MCS)	-1.0 Score on a scale Standard Error 0.82	0.3 Score on a scale Standard Error 0.66

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The PCS is a summary scale of the subscales physical functioning, role-physical, bodily pain, and general health. The component scale is norm-based to a standard population. A higher score indicates a better health.

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the SF-36 Physical Component Scale (PCS)	-0.4 Score on a scale Standard Error 0.66	0.3 Score on a scale Standard Error 0.53

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the PAC-QoL Subscale 'Worries and Concerns'	-0.1 Score on a scale Standard Error 0.07	-0.6 Score on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the PAC-QoL Subscale 'Physical Discomfort'	-0.2 Score on a scale Standard Error 0.09	-1.0 Score on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the PAC-QoL Subscale 'Psychosocial Discomfort'	-0.1 Score on a scale Standard Error 0.07	-0.3 Score on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the PAC-QoL Subscale 'Satisfaction'	-0.2 Score on a scale Standard Error 0.12	-1.4 Score on a scale Standard Error 0.10

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure

The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL

Outcome measures

Measure	Placebo n=117 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=239 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline in the PAC-QoL Overall Score	-0.1 Score on a scale Standard Error 0.08	-0.8 Score on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure

Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range

Outcome measures

Measure	Placebo n=114 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=235 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline for Sodium (Normalized Value)	-0 mmol/L Standard Deviation 3	-0 mmol/L Standard Deviation 3

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure

Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range

Outcome measures

Measure	Placebo n=114 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=235 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline for Potassium (Normalized Value)	0.0 mmol/L Standard Deviation 0.3	-0.0 mmol/L Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure

Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range

Outcome measures

Measure	Placebo n=114 Participants Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=235 Participants Two bisacodyl 5 mg tablets once daily
Change From Baseline for Chloride (Normalized Value)	0 mmol/L Standard Deviation 3	0 mmol/L Standard Deviation 3

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Bisacodyl

Serious events: 1 serious events

Other events: 159 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=121 participants at risk Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=247 participants at risk Two bisacodyl 5 mg tablets once daily
Pregnancy, puerperium and perinatal conditions Pregnancy	0.83% 1/121 • 4 Weeks	0.00% 0/247 • 4 Weeks
General disorders Chest pain	0.00% 0/121 • 4 Weeks	0.40% 1/247 • 4 Weeks
Injury, poisoning and procedural complications Fall	0.83% 1/121 • 4 Weeks	0.00% 0/247 • 4 Weeks
Injury, poisoning and procedural complications Tibia fracture	0.83% 1/121 • 4 Weeks	0.00% 0/247 • 4 Weeks

Other adverse events

Measure	Placebo n=121 participants at risk Two bisacodyl-matching 5 mg placebo tablets once daily	Bisacodyl n=247 participants at risk Two bisacodyl 5 mg tablets once daily
Gastrointestinal disorders Diarrhoea	1.7% 2/121 • 4 Weeks	53.4% 132/247 • 4 Weeks
Gastrointestinal disorders Abdominal pain	2.5% 3/121 • 4 Weeks	24.7% 61/247 • 4 Weeks
Gastrointestinal disorders Abdominal pain upper	2.5% 3/121 • 4 Weeks	7.7% 19/247 • 4 Weeks
Nervous system disorders Headache	5.8% 7/121 • 4 Weeks	3.2% 8/247 • 4 Weeks

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
• Publication restrictions are in place

Restriction type: OTHER