Trial Outcomes & Findings for Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation (NCT NCT01117051)
NCT ID: NCT01117051
Last Updated: 2021-06-11
Results Overview
A bowel movement (BM) was defined as spontaneous if no laxatives were taken in the 24 hours preceding that BM.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
174 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-06-11
Participant Flow
Participant milestones
| Measure |
Placebo
placebo once daily before breakfast for up to 12 weeks
|
Prucalopride
1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
88
|
|
Overall Study
COMPLETED
|
73
|
77
|
|
Overall Study
NOT COMPLETED
|
13
|
11
|
Reasons for withdrawal
| Measure |
Placebo
placebo once daily before breakfast for up to 12 weeks
|
Prucalopride
1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Did not meet in-/exclusion criteria
|
0
|
1
|
|
Overall Study
Sponsor's decision
|
3
|
1
|
|
Overall Study
Surgical procedure
|
0
|
1
|
|
Overall Study
Randomized by mistake
|
0
|
1
|
|
Overall Study
Convenience issue
|
1
|
0
|
Baseline Characteristics
Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
Baseline characteristics by cohort
| Measure |
Placebo
n=83 Participants
placebo once daily before breakfast for up to 12 weeks
|
Prucalopride
n=86 Participants
1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 11.67 • n=99 Participants
|
55.7 years
STANDARD_DEVIATION 12.15 • n=107 Participants
|
56.7 years
STANDARD_DEVIATION 11.92 • n=206 Participants
|
|
Age, Customized
Between >=18 and <65 years
|
62 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
|
Age, Customized
Between >=65 and <75 years
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Age, Customized
>=75 years
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Region of Enrollment
Bulgaria
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
Czech Republic
|
40 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
Romania
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intent-to-Treat (ITT) population includes all subjects who were randomized into the study and who had received at least 1 dose of investigational medication.
A bowel movement (BM) was defined as spontaneous if no laxatives were taken in the 24 hours preceding that BM.
Outcome measures
| Measure |
Placebo
n=83 Participants
once daily before breakfast for up to 12 weeks
|
Prucalopride
n=86 Participants
1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
|
|---|---|---|
|
Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week
|
39.8 percentage of subjects
|
48.8 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 2Population: ITT (subjects in the ITT whose post-dose samples were collected outside the 5-hour sampling window were not used in the plasma concentration calculation)
Outcome measures
| Measure |
Placebo
n=62 Participants
once daily before breakfast for up to 12 weeks
|
Prucalopride
1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
|
|---|---|---|
|
Plasma Concentration of Prucalopride at Week 2
pre-dose
|
2.827 ng/ml
Standard Deviation 1.5989
|
—
|
|
Plasma Concentration of Prucalopride at Week 2
5 hours post-dose
|
6.107 ng/ml
Standard Deviation 2.8839
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: ITT (subjects in the ITT whose post-dose samples were collected outside the 5-hour sampling window were not used in the plasma concentration calculation)
Outcome measures
| Measure |
Placebo
n=53 Participants
once daily before breakfast for up to 12 weeks
|
Prucalopride
1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
|
|---|---|---|
|
Plasma Concentration of Prucalopride at Week 8
pre-dose
|
3.179 ng/ml
Standard Deviation 1.9066
|
—
|
|
Plasma Concentration of Prucalopride at Week 8
5 hours post-dose
|
6.615 ng/ml
Standard Deviation 2.5758
|
—
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Prucalopride
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=83 participants at risk
once daily before breakfast for up to 12 weeks
|
Prucalopride
n=86 participants at risk
1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/83
|
1.2%
1/86
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/83
|
1.2%
1/86
|
|
Infections and infestations
Hepatitis A
|
1.2%
1/83
|
0.00%
0/86
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
1/83
|
0.00%
0/86
|
Other adverse events
| Measure |
Placebo
n=83 participants at risk
once daily before breakfast for up to 12 weeks
|
Prucalopride
n=86 participants at risk
1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.0%
5/83
|
10.5%
9/86
|
|
Gastrointestinal disorders
Flatulence
|
1.2%
1/83
|
4.7%
4/86
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
2/83
|
3.5%
3/86
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
4/83
|
3.5%
3/86
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
4/83
|
2.3%
2/86
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
3/83
|
2.3%
2/86
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/83
|
4.7%
4/86
|
|
Infections and infestations
Influenza
|
1.2%
1/83
|
2.3%
2/86
|
|
Nervous system disorders
Headache
|
2.4%
2/83
|
4.7%
4/86
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
1/83
|
2.3%
2/86
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/83
|
2.3%
2/86
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
2/83
|
1.2%
1/86
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
2/83
|
0.00%
0/86
|
|
Vascular disorders
Hypertension
|
2.4%
2/83
|
0.00%
0/86
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.4%
2/83
|
1.2%
1/86
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER