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Study Comparing PEG 3350 Laxative to Placebo in the Treatment of Occasional Constipation (Study CL2007-12)(P08216)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00770432
Recruitment Status : Completed
First Posted : October 10, 2008
Results First Posted : August 12, 2009
Last Update Posted : October 2, 2018
Information provided by (Responsible Party):

Brief Summary:
Randomized, placebo-controlled, double blind study. 203 subjects entered the study to compare the effect on occasional constipation of polyethylene glycol 3350 to placebo. Subjects took one of study treatments up to 7 days.

Condition or disease Intervention/treatment Phase
Constipation Drug: Polyethylene glycol 3350 Other: Placebo, maltodextrin 500 powder for solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind, Trial of Polyethylene Glycol 3350 Laxative for the Treatment of Occasional Constipation.
Study Start Date : November 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Active Comparator: Polyethylene glycol 3350 powder for solution
MiraLAX® (polyethylene glycol 3350 powder for solution)
Drug: Polyethylene glycol 3350
Polyethylene glycol 3350 powder for solution. Single dose (17 grams in 4 to 8 ounces of beverage) for 7 days.
Other Name: MiraLAX®

Placebo Comparator: Placebo
MALTRIN 500® M500 (maltodextrin 500)
Other: Placebo, maltodextrin 500 powder for solution
Maltodextrin 500 powder for solution, One single dose (one capful) in any 4 - 8 ounces beverage for 7 days.
Other Name: MALTRIN® 500 powder for solution

Primary Outcome Measures :
  1. Number of Participants With a Complete Resolution at the Final Visit [ Time Frame: 24 hours to 3 days after last dose of seven day treatment period. ]
    A resolution was recorded if the participant has no occurrence of two or more consecutive unsuccessful bowel movements for the rest of the study following the first successful bowel movement.

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects (or parents/guardians of minors) must demonstrate their willingness to participate (or to have their children/wards participate) in the study and comply with its procedures by signing a written informed consent. Minor subjects must provide written assent.
  • Subjects must be 17 years of age or older.
  • Subjects must present with a current diagnosis of untreated constipation for 7 days or less based on having signs/symptoms of straining and hard or lumpy stools OR the inability to have a BM within 48 hours prior to randomization into the trial.
  • Subjects must be OTC laxative users for the treatment of occasional constipation (defined as using a nonprescription laxative to treat at least 3 episodes of constipation within the last 12 months prior to randomization).
  • Subjects must be willing to use study drug for up to 7 days as directed, and must agree to record bowel movement (frequency, consistency, etc.) accurately and consistently in a daily diary, and make two clinic visits.
  • Subjects must be otherwise in good health, as determined by physical exam and medical history.
  • Subjects must agree not to use any other products to treat their constipation during the course of the study.
  • Subjects must agree not to use any medication known to cause constipation during the course of the study.
  • Subjects must agree to maintain a similar diet from the week prior to randomization through end of study.
  • Female subjects must be either surgically sterile, 2 years post-menopausal, or they attest that they are using an acceptable method of contraception (including hormonal birth control, IUD, double barrier methods, or vasectomized partner). In females of childbearing potential, the urine pregnancy test (HCG) must be negative at Baseline.
  • Subjects must be able to read the diaries in English.

Exclusion Criteria:

  • Subjects currently under a doctor's care and treatment for constipation.
  • Subjects having current constipation episode for more than one week prior to randomization.
  • Subjects that have a history of chronic constipation due to any underlying cause (inflammatory bowel disease, etc.).
  • Subjects have a history of more than 3 months of constipation in the past year.
  • Subjects have severe abdominal pain as the predominant constipation symptom.
  • Subjects who have previously used a polyethylene glycol laxative.
  • Subjects who have celiac disease or known gluten sensitivity.
  • Subjects who have a history of colorectal cancer, anal abscess, anal fistula, anal fissure, anal stenosis, gastric retention or obstruction, bowel resection, rectocele, or colostomy.
  • Subjects with known renal or hepatic insufficiency.
  • Subjects with gastrointestinal bleeding or acute infection.
  • Subjects with a history of alcohol or drug abuse.
  • Subjects with a history of psychiatric disorders.
  • Subjects with a history of significant ongoing medical problems, including kidney disease, or who are scheduled for surgical procedures.
  • Subjects currently taking or taken within 7 days of randomization a concomitant medication that causes constipation including for example opiates, antidepressants, SSRI's, antimotility agents, and anticholinergics, etc.
  • Subjects who plan to use laxatives during the treatment period other than the study medication.
  • Subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
  • Subjects who have participated in an investigational clinical surgical, drug or device study within the past 30 days.
  • Subjects who are pregnant or lactating.
  • Subjects who are allergic to polyethylene glycol or maltodextrin.
  • Subjects who are employed or have immediate family members employed by a company that manufactures laxative products.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bayer Identifier: NCT00770432    
Other Study ID Numbers: 18130
P08216 ( Other Identifier: Merck )
First Posted: October 10, 2008    Key Record Dates
Results First Posted: August 12, 2009
Last Update Posted: October 2, 2018
Last Verified: September 2018
Keywords provided by Bayer:
Human Experimentation
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms
Polyethylene glycol 3350
Pharmaceutical Solutions
Gastrointestinal Agents