Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)
Condition: Constipation
MeSH terms: Constipation
Intervention: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)
Intervention description: 13.125 g of PEG 3350 powder with approximately 0.6 g of electrolytes
Intervention MeSH terms: Polyethylene glycol 3350; Laxatives
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to evaluate the proportion of subjects with a bowel
      movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of
      treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus
      Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). The doses specified relate to the doses
      of PEG. Secondary objectives were measured by analysis of a subject diary and self-reported
      BM data. The secondary objectives included comparisons of PEG+E doses at 24 h for: BM
      control; relief of gas; relief of bloating; and relief of abdominal discomfort/cramping.

      In addition, the proportion of subjects with a BM (without straining and without hard and/or
      lumpy stool) within the first 24 h of treatment for subjects taking different doses of PEG+E
      was evaluated for the time to first BM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A willingness to participate in the study and comply with its procedures

          -  Must be ambulatory

          -  Male or female subjects aged 18 years or older who met two or more of the following
             modified Rome III-based criteria for constipation: (a) straining during at least 25%
             of defecations; (b) lumpy or hard stools in at least 25% of defecations; (c) sensation
             of incomplete evacuation for at least 25% of defecation; (d) sensation of anorectal
             obstruction/blockage for at least 25% of defecations; (e) manual maneuvers to
             facilitate at least 25% of defecations (eg, digital evacuation, support of the pelvic
             floor), and (f) fewer than 3 defecations per week

          -  Criteria fulfilled for the last 3 months with symptom onset at least 6 mo prior to
             diagnosis

          -  Had a self reported or documented history of chronic constipation

          -  Agreed not to use laxatives other than the study treatment from baseline/informed
             consent to end-of-study

          -  Agreed to maintain a similar diet from the week before Visit 3 to the end-of-study
             were to be enrolled

          -  Additionally required not to use any treatment known to cause constipation during the
             study (for subjects enrolled after Amendment 1)

          -  If a female subject, either surgically sterile, 2 years postmenopausal, or using an
             acceptable method of contraception. Abstinence was not an acceptable method of
             contraception. Females of childbearing potential had to have a urine pregnancy test
             (human chorionic gonadotropin [HCG]) that was negative at Visit 3

          -  Be able to read and write in the diaries in English

        Exclusion Criteria:

          -  Had loose stools without the use of laxatives

          -  Recurrent abdominal pain

          -  Known or suspected bowel perforation, obstruction, or fecal impaction; or had gastric
             retention, inflammatory bowel disease, bowel resection, or colostomy

          -  Celiac disease or known gluten sensitivity

          -  Known renal or hepatic insufficiency

          -  Recent history of alcohol abuse or drug abuse

          -  History of psychiatric disorders

          -  History of significant ongoing medical problems or scheduled for surgical procedures

          -  Subjects who, in the opinion of the Investigator, should not have been included in the
             study for any reason, including inability to follow study procedures

          -  Participated in an investigational clinical, surgical, drug or device study within the
             past 30 days

          -  Pregnant or lactating

          -  Allergic to PEG or PEG+E

          -  Employed by or have immediate family members employed by a company that manufactures
             laxative products

          -  Participant or family member of the Investigator or site staff directly involved with
             this study