Trial · NCT04534465
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.
NCT04534465, Phase 4, Completed, Bayer; results first posted 2020-11-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT04534465. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04534465
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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.
- NCT number
- NCT04534465
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 50 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Constipation
- Interventions
- Polyethylene glycol (MiraLAX, BAY81-8430), Mannitol
- First posted
- 2020-09-01
- Last updated
- 2020-11-12
- Results first posted
- 2020-11-12
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With the Opinion of the Products' Flavor | 1 day | 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 |
| Primary | Number of Participants With the Opinion of the Amount of Flavor in the Products | 1 day | Evaluated by 7-point scales: -3 -extremely weak, -2 -somewhat weak, -1 -slightly weak, 0 -just the right level of flavor, 1 -slightly intense, 2 -moderately intense, 3 -much too intense |
| Primary | Number of Participants With the Opinion of the Products' Sweetness | 1 day | Evaluated by 7-point scales: -3 -no sweetness needed, -2 -needs to be moderately sweeter, -1 -needs to be a little sweeter, 0 -just the right level of sweetness, 1 -slightly too sweet, 2 -moderately sweet, 3 -much too sweet |
| Primary | Number of Participants With/Without Cooling Sensation in the Products. | 1 day | Whether or not subjects felt a cooling sensation (yes/no). |
| Primary | Number of Participants With Different Levels of Cooling Sensation of the Products | 1 day | Evaluated by 4-point scales: 1 -barely perceptible, 2 -slightly noticeable, 3 -moderately noticeable, 4 -extremely noticeable |
| Primary | Number of Participants With the Opinion of Aftertaste in the Products. | 1 day | Whether or not subjects experienced aftertaste (yes/no). |
| Primary | Number of Participants With Different Levels of Aftertaste of the Products | 1 day | Evaluated by 3-point scales: 1 -slightly noticeable, 2 -moderately noticeable, 3 -extremely noticeable |
| Secondary | Number of Participants With no Bowel Movement | 1 day | The number of subjects who did not report any bowel movement was evaluated. |
| Secondary | Time to First Bowel Movement (In Hours) | 1 day | The mean and standard deviation of the time to first bowel movement in hours were evaluated. |
| Secondary | Number of Participants for Gas Rating | 1 day | A gas rating score of 0 means that there was no gas experienced, while a score of 1 represents slight gas experienced, 2 represents moderate gas experienced and 3 represents severe gas experienced. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With the Opinion of the Products' Flavor | 1 day | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With the Opinion of the Amount of Flavor in the Products | 1 day | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With the Opinion of the Products' Sweetness | 1 day | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With/Without Cooling Sensation in the Products. | 1 day | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With no Bowel Movement | 1 day | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to First Bowel Movement (In Hours) | 1 day | Hours | MEAN | |
| SECONDARY | Number of Participants for Gas Rating | 1 day | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants for Bloating Rating | 1 day | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants for Abdominal Discomfort Rating | 1 day | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With no Successful Bowel Movement | 1 day | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group250
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With the Opinion of the Products' Flavor | Dosing Arm 1 | 1- Extremely Dislike | 1 | Participants | |
| Number of Participants With the Opinion of the Products' Flavor | Dosing Arm 2 | 1- Extremely Dislike | 0 | Participants | |
| Number of Participants With the Opinion of the Products' Flavor | Dosiing Arm 3 | 1- Extremely Dislike | 0 | Participants | |
| Number of Participants With the Opinion of the Products' Flavor | Dosing Arm 4 | 1- Extremely Dislike | 0 | Participants | |
| Number of Participants With the Opinion of the Products' Flavor | Dosing Arm 5 | 1- Extremely Dislike | 0 | Participants | |
| Number of Participants With the Opinion of the Products' Flavor | Dosing Arm 1 | 2- Moderately Dislike | 0 | Participants | |
| Number of Participants With the Opinion of the Products' Flavor | Dosing Arm 2 | 2- Moderately Dislike | 3 | Participants | |
| Number of Participants With the Opinion of the Products' Flavor | Dosiing Arm 3 | 2- Moderately Dislike | 0 | Participants | |
| Number of Participants With the Opinion of the Products' Flavor | Dosing Arm 4 | 2- Moderately Dislike | 0 | Participants | |
| Number of Participants With the Opinion of the Products' Flavor | Dosing Arm 5 | 2- Moderately Dislike | 0 | Participants |
1 to 10 of 250Source ClinicalTrials.gov
See all 250 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dosing Arm 1 | 10 | |
| Overall Study | STARTED | Dosing Arm 2 | 10 | |
| Overall Study | STARTED | Dosing Arm 3 | 10 | |
| Overall Study | STARTED | Dosing Arm 4 | 10 | |
| Overall Study | STARTED | Dosing Arm 5 | 10 | |
| Overall Study | COMPLETED | Dosing Arm 1 | 10 | |
| Overall Study | COMPLETED | Dosing Arm 2 | 10 | |
| Overall Study | COMPLETED | Dosing Arm 3 | 10 | |
| Overall Study | COMPLETED | Dosing Arm 4 | 10 | |
| Overall Study | COMPLETED | Dosing Arm 5 | 10 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events25
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 | Increased Gas | Gastrointestinal disorders | Dosing Arm 1 | 3 | 10 | |
| other | Increased Gas | Gastrointestinal disorders | Dosing Arm 2 | 2 | 10 | |
| other | Increased Gas | Gastrointestinal disorders | Dosing Arm 3 | 2 | 10 | |
| other | Increased Gas | Gastrointestinal disorders | Dosing Arm 4 | 6 | 10 | |
| other | Increased Gas | Gastrointestinal disorders | Dosing Arm 5 | 5 | 10 | |
| other | Increased Bloating | Gastrointestinal disorders | Dosing Arm 1 | 1 | 10 | |
| other | Increased Bloating | Gastrointestinal disorders | Dosing Arm 2 | 0 | 10 | |
| other | Increased Bloating | Gastrointestinal disorders | Dosing Arm 3 | 4 | 10 | |
| other | Increased Bloating | Gastrointestinal disorders | Dosing Arm 4 | 0 | 10 | |
| other | Increased Bloating | Gastrointestinal disorders | Dosing Arm 5 | 1 | 10 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dosing Arm 1 | 0 | 10 |
| Total, all-cause mortality | Dosing Arm 2 | 0 | 10 |
| Total, all-cause mortality | Dosing Arm 3 | 0 | 10 |
| Total, all-cause mortality | Dosing Arm 4 | 0 | 10 |
| Total, all-cause mortality | Dosing Arm 5 | 0 | 10 |
| Total, other adverse events | Dosing Arm 1 | 6 | 10 |
| Total, other adverse events | Dosing Arm 2 | 3 | 10 |
| Total, other adverse events | Dosing Arm 3 | 4 | 10 |
| Total, other adverse events | Dosing Arm 4 | 7 | 10 |
| Total, other adverse events | Dosing Arm 5 | 6 | 10 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT04534465
GET https://conductscience.org/api/trials/v1/NCT04534465/results?page=2