Trial · NCT01707667

Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity

NCT01707667, Phase 4, Completed, Shire; results first posted 2014-10-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity. Trials, record NCT01707667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01707667

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity
NCT number: NCT01707667
Status: Completed
Phases: Phase 4
Enrollment: 13 participants, actual
Lead sponsor: Shire
Conditions: Chronic Constipation
Interventions: prucalopride, PEG 3350
First posted: 2012-10-16
Last updated: 2021-07-02
Other registries' IDs: eudract:2012-002495-13
Results first posted: 2014-10-22

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Number of High-Amplitude Propagating Contractions (HAPC)	over 12 hours post-dose	Manometry recordings were read by an experienced gastroenterologist who was blinded to the treatment each subject received. The tracings were analyzed using computer-based validated software. HAPC and manometry data were available for every sensor as well as average values for each HAPC and manometry time point. The primary outcome analysis of HAPC data used the following threshold: Mean amplitude ≥100mmHg and extension ≥20cm (9 sensors).
Secondary	Area Under the Concentration Curve (AUC) of All HAPCs	over 12 hours post-dose	The AUC of all HAPCs during the first 12 hours after treatment was calculated as the sum of the AUC at all sensors of each HAPC at the ≥100mmHg and ≥20cm threshold.
Secondary	The Mean Amplitude of HAPC	over 12 hours post-dose	The mean amplitude of all HAPCs was calculated as the sum of the mean amplitude for each HAPC divided by the number of HAPCs.
Secondary	Time to First HAPC	over 12 hours post-dose	The median (95% CI) time to first HAPC after administration of investigational product with amplitude ≥100mmHg and extension ≥20cm.
Secondary	Propagation Velocity of HAPC	over 12 hours post-dose	Propagation velocity was calculated as the extension divided by the duration for each HAPC. Mean propagation velocity is the sum of the propagation velocities divided by the number of HAPCs.
Secondary	Duration of HAPC	over 12 hours post-dose	The mean duration of all HAPCs was calculated as the sum of the duration of each HAPC divided by the number of HAPCs.
Secondary	Motility Index	over 12 hours post-dose	Motility index (mmHg) was summarized for the following 3 time points: pre-dose, 0-5 hours post-dose, and 5-12 hours post-dose. The motility index is defined as the natural logarithm of all peak amplitudes of every contraction +1.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Number of High-Amplitude Propagating Contractions (HAPC)	over 12 hours post-dose	The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.	Number of HAPC with amplitude ≥100mmHg	LEAST_SQUARES_MEAN
SECONDARY	Area Under the Concentration Curve (AUC) of All HAPCs	over 12 hours post-dose	The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.	mmHg.sec	LEAST_SQUARES_MEAN
SECONDARY	The Mean Amplitude of HAPC	over 12 hours post-dose	The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Time to First HAPC	over 12 hours post-dose	The Pharmacodynamic Analysis Set included all subjects in the Safety Analysis Set who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.	hours	MEDIAN
SECONDARY	Propagation Velocity of HAPC	over 12 hours post-dose	The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.	cm/sec	LEAST_SQUARES_MEAN
SECONDARY	Duration of HAPC	over 12 hours post-dose	The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.	sec	LEAST_SQUARES_MEAN
SECONDARY	Motility Index	over 12 hours post-dose	The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.	mmHg	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
The Number of High-Amplitude Propagating Contractions (HAPC)	Prucalopride	8.7	Standard Error 2.06	Number of HAPC with amplitude ≥100mmHg
The Number of High-Amplitude Propagating Contractions (HAPC)	PEG 3350	2.9	Standard Error 2.06	Number of HAPC with amplitude ≥100mmHg
Area Under the Concentration Curve (AUC) of All HAPCs	Prucalopride	110204.1	Standard Error 28279.91	mmHg.sec
Area Under the Concentration Curve (AUC) of All HAPCs	PEG 3350	41152.7	Standard Error 34432.61	mmHg.sec
The Mean Amplitude of HAPC	Prucalopride	199.0	Standard Error 15.15	mmHg
The Mean Amplitude of HAPC	PEG 3350	189.8	Standard Error 19.56	mmHg
Time to First HAPC	Prucalopride	4.5	95% Confidence Interval 1.5 to 9.3	hours
Time to First HAPC	PEG 3350	NA	95% Confidence Interval 2.8 to NA	hours
Propagation Velocity of HAPC	Prucalopride	0.467	Standard Error 0.0803	cm/sec
Propagation Velocity of HAPC	PEG 3350	0.646	Standard Error 0.1074	cm/sec

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1	STARTED	PRU-PEG	7
Period 1	STARTED	PEG-PRU	6
Period 1	COMPLETED	PRU-PEG	6
Period 1	COMPLETED	PEG-PRU	6
Period 1	NOT COMPLETED	PRU-PEG	1
Period 1	NOT COMPLETED	PEG-PRU	0
Period 2	STARTED	PRU-PEG	6
Period 2	STARTED	PEG-PRU	6
Period 2	COMPLETED	PRU-PEG	6
Period 2	COMPLETED	PEG-PRU	6

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events10

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	ABDOMINAL PAIN	Gastrointestinal disorders	Prucalopride	2	13	2
other	ABDOMINAL PAIN	Gastrointestinal disorders	Polyethylene Glycol	0	12	0
other	DIARRHOEA	Gastrointestinal disorders	Prucalopride	1	13	1
other	DIARRHOEA	Gastrointestinal disorders	Polyethylene Glycol	0	12	0
other	NAUSEA	Gastrointestinal disorders	Prucalopride	1	13	1
other	NAUSEA	Gastrointestinal disorders	Polyethylene Glycol	0	12	0
other	RECTAL HAEMORRHAGE	Gastrointestinal disorders	Prucalopride	1	13	1
other	RECTAL HAEMORRHAGE	Gastrointestinal disorders	Polyethylene Glycol	0	12	0
other	HEADACHE	Nervous system disorders	Prucalopride	1	13	1
other	HEADACHE	Nervous system disorders	Polyethylene Glycol	0	12	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Prucalopride
Total, all-cause mortality	Polyethylene Glycol
Total, other adverse events	Prucalopride	3	13
Total, other adverse events	Polyethylene Glycol	0	12
Total, serious adverse events	Prucalopride	0	13
Total, serious adverse events	Polyethylene Glycol	0	12

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27270968	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Prucalopride vs Polyethylene Glycol: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01707667

GET https://conductscience.org/api/trials/v1/NCT01707667/registered

API reference For AI assistants