Phase 4
Completed N=50
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.
Source: ClinicalTrials.gov NCT04534465 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Number of Participants With the Opinion of the Products' Flavor — 1; 0; 0; 0 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Opinion of the Products' Flavor |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With the Opinion of the Amount of Flavor in the Products |
0; 0; 1; 0; 0; 1 | — |
| PRIMARY Number of Participants With the Opinion of the Products' Sweetness |
0; 0; 1; 1; 1; 1 | — |
| PRIMARY Number of Participants With/Without Cooling Sensation in the Products. |
1; 1; 3; 2; 3; 9 | — |
| PRIMARY Number of Participants With Different Levels of Cooling Sensation of the Products |
0; 0; 0; 0; 1; 1 | — |
| PRIMARY Number of Participants With the Opinion of Aftertaste in the Products. |
1; 4; 6; 8; 5; 9 | — |
| PRIMARY Number of Participants With Different Levels of Aftertaste of the Products |
0; 3; 4; 3; 4; 1 | — |
| SECONDARY Number of Participants With no Bowel Movement |
1; 2; 1; 1; 1 | — |
| SECONDARY Time to First Bowel Movement (In Hours) |
6.672; 5.444; 5.117; 2.470; 4.543 | — |
| SECONDARY Number of Participants for Gas Rating |
0; 2; 2; 0; 1; 4 | — |
| SECONDARY Number of Participants for Bloating Rating |
5; 5; 1; 1; 4; 2 | — |
| SECONDARY Number of Participants for Abdominal Discomfort Rating |
3; 5; 9; 4; 6; 6 | — |
| SECONDARY Number of Participants With no Successful Bowel Movement |
7; 6; 3; 5; 6 | — |
| SECONDARY Time to First Successful Bowel Movement (In Hours) |
4.311; 9.967; 8.462; 3.587; 4.683 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Event |
0; 0; 0; 0; 0; 6 | — |
Eligibility Criteria
Male and female subjects, aged 18 years and older, suffering with occasional constipation
Data sourced from ClinicalTrials.gov (NCT04534465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.