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 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.

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Drug: Mannitol

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38151
      • Merck Consumer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dosing arm 1; MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Oral solution, 17g polyethylene glycol, one time; Drug: Mannitol; Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Experimental: Dosing arm 2; MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Oral solution, 17g polyethylene glycol, one time; Drug: Mannitol; Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Experimental: Dosing arm 3; MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Oral solution, 17g polyethylene glycol, one time; Drug: Mannitol; Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Experimental: Dosing arm 4; MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Oral solution, 17g polyethylene glycol, one time; Drug: Mannitol; Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Experimental: Dosing arm 5; MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)	Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Oral solution, 17g polyethylene glycol, one time; Drug: Mannitol; Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	1 day
Number of Participants With/Without Cooling Sensation in the Products.	Whether or not subjects felt a cooling sensation (yes/no).	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	1 day
Number of Participants With the Opinion of Aftertaste in the Products.	Whether or not subjects experienced aftertaste (yes/no).	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	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With no Bowel Movement	The number of subjects who did not report any bowel movement was evaluated.	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.	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.	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.	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.	1 day
Number of Participants With no Successful Bowel Movement	The number of subjects who did not report the successful bowel movement was evaluated.	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.	1 day
Number of Participants With Treatment Emergent Adverse Event	Including serious adverse events and adverse events.	1 day

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2013
• Primary Completion (Actual): March 19, 2013
• Study Completion (Actual): March 19, 2013

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Physiological Effects of Drugs; Gastrointestinal Agents; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Laxatives; Mannitol; Polyethylene glycol 3350
• Other Study ID Numbers: 18160

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No