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NCT01707667 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Shire.

Completed
Registry status
Phase 4
Development phase
13
Enrollment target

NCT01707667: Completed Phase 4 study, sponsored by Shire.

NCT01707667 is a Phase 4 study that has completed, run by Shire. The registered enrollment target is 13 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01707667, a Phase 4 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 4
Development phase
13 participants
Enrollment target

Study Summary

To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor activity in subjects that are chronically constipated.

Primary Outcome

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).

Interventions

  • DRUG PEG 3350
  • DRUG prucalopride

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2013-02-27
Est. Completion 2013-11-27
Phase Phase 4
Shire

245 total trials

What the finished NCT01707667 record still lists

NCT01707667 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which PEG 3350 is the first listed.

NCT01707667 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01707667 about?

NCT01707667 is a clinical study titled "Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity". To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor activity in subjects that are chronically constipated.

What is the current status of trial NCT01707667?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 13 participants. The study started on 2013-02-27. Estimated completion is 2013-11-27.

What interventions are being tested in trial NCT01707667?

The interventions under investigation include: PEG 3350 (DRUG), prucalopride (DRUG).

Who is sponsoring clinical trial NCT01707667?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01707667's enrollment target sits among peer trials

13 1910th of 2000 higher than 88 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01707667, the US trial registry maintained by the National Library of Medicine. NCT01707667 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.