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NCT04534465 · ClinicalTrials.gov registry record · Phase 4

Study to Gather Information on the Acceptability of a New Flavor System With Increasing Levels of 2, 4, 6 g or Higher of Mannitol for PEG 3350 in Subjects Having Infrequent Bowel Movements.

A Phase 4 study of Constipation, sponsored by Bayer.

Completed
Registry status
Phase 4
Development phase
50
Enrollment target
1
Study location

NCT04534465: Completed Phase 4 study of Constipation, sponsored by Bayer.

NCT04534465 is a Phase 4 study of Constipation that has completed, run by Bayer. The registered enrollment target is 50 participants, below the 204-participant average among 54 other Constipation trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04534465, a Phase 4 study of Constipation, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 4
Development phase
50 participants
Enrollment target
1
Study location

Study Summary

Study to gather information on the acceptability of a new flavor system with increasing levels of 2, 4, 6 g or higher of the sugar alcohol Mannitol for Polyethylene glycol (PEG) 3350 a drug stimulating bowel movement to pass stool in subjects having infrequent bowel movements. The taste of the various preparations will be measured by use of a rating scale.

Primary Outcome

Evaluated by 7-point scales: 1-extremely dislike, 2-moderately dislike, 3-dislike somewhat, 4-neither like nor dislike, 5-like somewhat, 6-moderately like, 7-extremely like

Conditions Studied

Interventions

  • DRUG Polyethylene glycol (MiraLAX, BAY81-8430)
  • DRUG Mannitol

Study Locations (1)

Tennessee

  • Merck Consumer Center - Memphis

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2013-02-13
Est. Completion 2013-03-19
Phase Phase 4
Bayer

591 total trials

What the finished NCT04534465 record still lists

NCT04534465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 204-participant average among 54 other Constipation trials with a reported enrollment target (75% lower).

The record links to 1 condition, with Constipation appearing as the primary indexed condition, and to 2 interventions - of which Polyethylene glycol (MiraLAX, BAY81-8430) is the first listed.

NCT04534465 reports a single indexed study location in Tennessee.

Frequently Asked Questions

What is clinical trial NCT04534465 about?

NCT04534465 is a clinical study titled "Study to Gather Information on the Acceptability of a New Flavor System With Increasing Levels of 2, 4, 6 g or Higher of Mannitol for PEG 3350 in Subjects Having Infrequent Bowel Movements.". Study to gather information on the acceptability of a new flavor system with increasing levels of 2, 4, 6 g or higher of the sugar alcohol Mannitol for Polyethylene glycol (PEG) 3350 a drug stimulating bowel movement to pass stool in subjects having infrequent bowel movements. The taste of the vario...

What is the current status of trial NCT04534465?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2013-02-13. Estimated completion is 2013-03-19.

What conditions does trial NCT04534465 study?

This clinical trial studies the following conditions: Constipation.

What interventions are being tested in trial NCT04534465?

The interventions under investigation include: Polyethylene glycol (MiraLAX, BAY81-8430) (DRUG), Mannitol (DRUG).

Who is sponsoring clinical trial NCT04534465?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04534465 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Constipation

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04534465's enrollment target sits among peer trials

50 34th of 54 higher than 19 of 54 other Constipation trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Constipation 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 NCT04534465, the US trial registry maintained by the National Library of Medicine. NCT04534465 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.