ConstipationPhase 4NCT04534465

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 testing Polyethylene glycol (MiraLAX, BAY81-8430) and Mannitol in people with Constipation, run by Bayer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Constipation
What is being tested?: Polyethylene glycol (MiraLAX, BAY81-8430) and Mannitol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 13 Feb 2013to 19 Mar 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Male and female subjects, aged 18 years and older, suffering with occasional constipation

Trial locations and contacts

1 site in 1 country.

United States1 site

Merck Consumer Center
Memphis, Tennessee, 38151

Other trials in United States

About this study

Official title: A Single Center, Open-label, Parallel Arm, Phase 4 Study to Evaluate the Acceptability of a Prototype Flavor System With Ascending Levels of 2,4,6 Grams or Higher of Mannitol for PEG 3350 Laxative in Subjects Suffering With Occasional Constipation.

Conditions: Constipation
Being tested: Polyethylene glycol (MiraLAX, BAY81-8430), Mannitol
Medical subject headings: Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Polyethylene glycol (MiraLAX, BAY81-8430)Drug
Oral solution, 17g polyethylene glycol, one time
MannitolDrug
Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time

Study groups in NCT04534465
Study group	Role	What they receive
Dosing arm 1	Experimental	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) Receives: Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Drug: Mannitol
Dosing arm 2	Experimental	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) Receives: Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Drug: Mannitol
Dosing arm 3	Experimental	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) Receives: Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Drug: Mannitol
Dosing arm 4	Experimental	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) Receives: Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Drug: Mannitol
Dosing arm 5	Experimental	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total) Receives: Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Drug: Mannitol

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With the Opinion of the Products' Flavor
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
Measured: 1 day
Number of Participants With the Opinion of the Amount of Flavor in the Products
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
Measured: 1 day
Number of Participants With the Opinion of the Products' Sweetness
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
Measured: 1 day
Number of Participants With/Without Cooling Sensation in the Products.
Whether or not subjects felt a cooling sensation (yes/no).
Measured: 1 day
Number of Participants With Different Levels of Cooling Sensation of the Products
Evaluated by 4-point scales: 1 -barely perceptible, 2 -slightly noticeable, 3 -moderately noticeable, 4 -extremely noticeable
Measured: 1 day
Number of Participants With the Opinion of Aftertaste in the Products.
Whether or not subjects experienced aftertaste (yes/no).
Measured: 1 day
Number of Participants With Different Levels of Aftertaste of the Products
Evaluated by 3-point scales: 1 -slightly noticeable, 2 -moderately noticeable, 3 -extremely noticeable
Measured: 1 day

Secondary outcomes (8)

Number of Participants With no Bowel Movement
The number of subjects who did not report any bowel movement was evaluated.
Measured: 1 day
Time to First Bowel Movement (In Hours)
The mean and standard deviation of the time to first bowel movement in hours were evaluated.
Measured: 1 day
Number of Participants for Gas Rating
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.
Measured: 1 day
Number of Participants for Bloating Rating
A score of zero represents no bloating, while a score of 1 represents slight bloating, 2 represents moderate bloating and 3 represents severe bloating.
Measured: 1 day
Number of Participants for Abdominal Discomfort Rating
A score of 0 represents no abdominal pain, 1 represents slight abdominal pain, 2 represents moderate abdominal pain and 3 represents severe abdominal pain.
Measured: 1 day
Number of Participants With no Successful Bowel Movement
The number of subjects who did not report the successful bowel movement was evaluated.
Measured: 1 day
Time to First Successful Bowel Movement (In Hours)
The mean and standard deviation of the time to first successful bowel movement in hours were evaluated.
Measured: 1 day
Number of Participants With Treatment Emergent Adverse Event
Including serious adverse events and adverse events.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Feb 201319 Mar 2013

First posted1 Sep 2020
Study start13 Feb 2013
Primary completion19 Mar 2013
Study completion19 Mar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ConstipationStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04534465
Sponsor's protocol ID: 18160
Status last verified: Oct 2020
First submitted: 27 Aug 2020
Last updated: 12 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Center, Open-label, Parallel Arm, Phase 4 Study to Evaluate the Acceptability of a Prototype Flavor System With Ascending Levels of 2,4,6 Grams or Higher of Mannitol for PEG 3350 Laxative in Subjects Suffering With Occasional Constipation.
ClinicalTrials.gov ID: NCT04534465
Acronym / sponsor ID: 18160
Conditions: Constipation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 13 Feb 2013 (actual)
Primary completion: 19 Mar 2013 (actual)
Study completion: 19 Mar 2013 (actual)
First posted: 1 Sep 2020 (actual)
Results: Posted 12 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Dosing arm 1	Experimental	Drug: Polyethylene glycol (MiraLAX, BAY81-8430), Drug: MannitolMiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
Dosing arm 2	Experimental	Drug: Polyethylene glycol (MiraLAX, BAY81-8430), Drug: MannitolMiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
Dosing arm 3	Experimental	Drug: Polyethylene glycol (MiraLAX, BAY81-8430), Drug: MannitolMiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
Dosing arm 4	Experimental	Drug: Polyethylene glycol (MiraLAX, BAY81-8430), Drug: MannitolMiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
Dosing arm 5	Experimental	Drug: Polyethylene glycol (MiraLAX, BAY81-8430), Drug: MannitolMiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Polyethylene glycol (MiraLAX, BAY81-8430)Oral solution, 17g polyethylene glycol, one time	Drug	Dosing arm 1, Dosing arm 2, Dosing arm 3, Dosing arm 4, Dosing arm 5
MannitolOral, 2g, 4g, 6g, 8g and 10g mannitol, one time	Drug	Dosing arm 1, Dosing arm 2, Dosing arm 3, Dosing arm 4, Dosing arm 5

Primary outcome

Number of Participants With the Opinion of the Products' Flavor
Time frame: 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
Number of Participants With the Opinion of the Amount of Flavor in the Products
Time frame: 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
Number of Participants With the Opinion of the Products' Sweetness
Time frame: 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
Number of Participants With/Without Cooling Sensation in the Products.
Time frame: 1 day
Whether or not subjects felt a cooling sensation (yes/no).
Number of Participants With Different Levels of Cooling Sensation of the Products
Time frame: 1 day
Evaluated by 4-point scales: 1 -barely perceptible, 2 -slightly noticeable, 3 -moderately noticeable, 4 -extremely noticeable
Number of Participants With the Opinion of Aftertaste in the Products.
Time frame: 1 day
Whether or not subjects experienced aftertaste (yes/no).
Number of Participants With Different Levels of Aftertaste of the Products
Time frame: 1 day
Evaluated by 3-point scales: 1 -slightly noticeable, 2 -moderately noticeable, 3 -extremely noticeable

8 secondary outcomes

Number of Participants With no Bowel Movement
Time frame: 1 day
Time to First Bowel Movement (In Hours)
Time frame: 1 day
Number of Participants for Gas Rating
Time frame: 1 day
Number of Participants for Bloating Rating
Time frame: 1 day
Number of Participants for Abdominal Discomfort Rating
Time frame: 1 day
Number of Participants With no Successful Bowel Movement
Time frame: 1 day
Time to First Successful Bowel Movement (In Hours)
Time frame: 1 day
Number of Participants With Treatment Emergent Adverse Event
Time frame: 1 day

Results and safety

Results posted to the registry on 12 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dosing Arm 1	10	10
Dosing Arm 2	10	10
Dosing Arm 3	10	10
Dosing Arm 4	10	10
Dosing Arm 5	10	10

Primary outcome: Number of Participants With the Opinion of the Products' Flavor

Time frame: 1 day. Count of participants. Unit: Participants

Measure	Dosing Arm 1 n = 10	Dosing Arm 2 n = 10	Dosiing Arm 3 n = 10	Dosing Arm 4 n = 10	Dosing Arm 5 n = 10
1- Extremely Dislike	1	0	0	0	0
2- Moderately Dislike	0	3	0	0	0
3- Dislike Somewhat	1	1	1	0	0
4- Neither Like nor Dislike	4	1	4	0	1
5- Like Somewhat	3	1	2	4	3
6- Moderately Like	0	3	2	4	2
7- Extremely Like	1	1	1	2	4

Primary outcome: Number of Participants With the Opinion of the Amount of Flavor in the Products

Time frame: 1 day. Count of participants. Unit: Participants

Measure	Dosing Arm 1 n = 10	Dosing Arm 2 n = 10	Dosiing Arm 3 n = 10	Dosing Arm 4 n = 10	Dosing Arm 5 n = 10
-3 - Extremely Weak	0	0	1	0	0
-2 - Somewhat Weak	1	1	2	1	0
-1 - Slightly Weak	4	1	3	2	1
0 - Just the Right Level of Flavor	5	8	3	7	8
1 - Slightly Intense	0	0	1	0	1
2 - Moderately Intense	0	0	0	0	0
3 - Much Too Intense	0	0	0	0	0

Primary outcome: Number of Participants With the Opinion of the Products' Sweetness

Time frame: 1 day. Count of participants. Unit: Participants

Measure	Dosing Arm 1 n = 10	Dosing Arm 2 n = 10	Dosiing Arm 3 n = 10	Dosing Arm 4 n = 10	Dosing Arm 5 n = 10
-3 - No Sweetness Needed	0	0	1	1	1
-2 - Needs to be Moderately Sweeter	1	1	1	0	0
-1 - Needs to be a Little Sweeter	7	6	6	3	2
0 - Just the Right Level of Sweetness	2	3	2	5	7
1 - Slightly Too Sweet	0	0	0	1	0
2 - Moderately Sweet	0	0	0	0	0
3 - Much Too Sweet	0	0	0	0	0

Primary outcome: Number of Participants With/Without Cooling Sensation in the Products.

Time frame: 1 day. Count of participants. Unit: Participants

Measure	Dosing Arm 1 n = 10	Dosing Arm 2 n = 10	Dosiing Arm 3 n = 10	Dosing Arm 4 n = 10	Dosing Arm 5 n = 10
Yes	1	1	3	2	3
No	9	9	7	8	7

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dosing Arm 1	0 of 10 (0%)	6 of 10 (60%)	0 of 10
Dosing Arm 2	0 of 10 (0%)	3 of 10 (30%)	0 of 10
Dosing Arm 3	0 of 10 (0%)	4 of 10 (40%)	0 of 10
Dosing Arm 4	0 of 10 (0%)	7 of 10 (70%)	0 of 10
Dosing Arm 5	0 of 10 (0%)	6 of 10 (60%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Constipation

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bayer Study Director study director

Bayer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Polyethylene glycol (MiraLAX, BAY81-8430) and Mannitol in people with Constipation, run by Bayer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With the Opinion of the Products' Flavor (time frame: 1 day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04534465.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.