Study Comparing PEG 3350 Laxative to Placebo in the Treatment of Occasional Constipation (Study CL2007-12)(P08216)
Condition: Constipation
MeSH terms: Constipation
Intervention: Polyethylene glycol 3350; Placebo, maltodextrin 500 powder for solution
Intervention description: Polyethylene glycol 3350 powder for solution. Single dose (17 grams in 4 to 8 ounces of beverage) for 7 days.; Maltodextrin 500 powder for solution, One single dose (one capful) in any 4 - 8 ounces beverage for 7 days.
Intervention MeSH terms: Polyethylene glycol 3350; Pharmaceutical Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 203.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human Experimentation

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.
    

Eligibility criteria:

        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.