Study Completed

Constipation

Bayer Identifier:

18127

ClinicalTrials.gov Identifier:

NCT01885104

EudraCT Number:

Not Available

EU CT Number:

Not Available

CL2012-13-Evaluation of Oral Tolerance MiraLAX Solution

Trial purpose

The purpose of this study is to compare the safety and tolerability of oral ingestion of polyethylene glycol (PEG 3350) solution concentrate to oral ingestion of a placebo solution concentrate, in participants with constipation.

Key Participants Requirements

Sex

Both

Age

18 - 75 Years

Inclusion Criteria
- Ambulatory male or female with no history or current evidence of other conditions or abnormalities that would affect study results or interfere with
participation for full duration of study
- Meets diagnostic criteria for functional constipation. This includes loose stools that are rarely present without the use of laxatives and 2 or more of the following: straining during at least 25% of defecations; lumpy or hard stools in at least 25% of defecations; sensation of incomplete evacuation for at least 25% of defecations; sensation of anorectal obstruction/blockage for at least 25% of defecations; manual maneuvers to facilitate at least 25% of defecations [e.g., digital evacuation, support of the pelvic floor]; and fewer than 3 defecations per week. Criteria for functional constipation must be fulfilled for last 3 months, with symptom onset at least 6 months prior to diagnosis.
- Continuous or recurrent symptoms for at least 3 months of: abdominal pain or discomfort, relieved with defecation, or associated with a change in frequency or consistency of stool, and an irregular pattern of defecation at least 25% of the time with 3 or more of the following: altered stool frequency, altered stool form (hard or loose/watery), altered stool passage (straining or urgency, feeling of incomplete evacuation), passage of mucus, and bloating or abdominal distension.
- Agrees to not use laxatives other than study medication for the duration of the study period
Agrees to not use disallowed concomitant medications for the duration of the study
- Agrees to maintain a similar diet and level of activity from the period of the Screening Visit through End of Study
- Individuals of reproductive potential must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control and until 2 weeks after the last dose of study drug in the last treatment period. Acceptable methods of birth control include: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.
Exclusion Criteria

Trial summary

Enrollment Goal

Trial Dates

June 2013 - October 2013

Phase

Phase 2

Could I Receive a placebo

Yes

Products

Transipeg (Macrogol, BAY81-8430)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Madison, 53704, United States

Primary Outcome

Number of Participants With Inflammation of the Oral Mucosa
Time Frame:
Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment
Safety Issue:
Yes
Number of Participants With Inflammation of the Esophageal Mucosa
Time Frame:
Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment
Safety Issue:
Yes

Trial design

Evaluation of oral tolerance MiraLAX solution concentrate in subjects with chronic constipation.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Single Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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