EUCTR2005-006111-47-IEActive, not recruitingPhase 1
A double-blind, randomised, parallel group pilot study to compare macrogol 3350 + electrolytes versus placebo in the overnight relief of constipation - Transipeg
McNeil Ltd0 sites45 target enrollmentStarted: January 4, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 45
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •··Male and female patients
- •·Normal diet (vegan or weight loss diet not acceptable)
- •·Smoker of 10 cigarettes or less per day
- •·Aged between 18 and 60 years
- •·History of constipation for at least 3 months
- •·Meet eligibility criteria for functional constipation (see below)
- •·Acceptable medical history
- •·Acceptable findings on physical examination
- •·Acceptable vital signs
- •·Acceptable results for haematology, clinical chemistry and urinalysis
- •·Appropriate use of an effective method of contraception. The oral contraceptive pill is allowed (female patients only)
- •·Negative pregnancy test (female patients only)
- •·Ability to comprehend and communicate effectively with the Investigator and staff
- •·Ability to give written informed consent
- •Diagnostic criteria for functional constipation: (adapted from Rome II criteria [4])Constipation for at least 3 months and at least one of the following:1.Less than 3 motions /week 2.Hard and/or lumpy stools requiring straining;3.Sensation of incomplete evacuationLoose stools are not present, there are insufficient criteria for IBS, and there are no symptoms suggestive of bowel cancer.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1··Severe intractable constipation or faecal impaction
- •·Medication which would interfere with study conduct or study assessments or which is commonly known to cause constipation
- •·Positive alcohol test prior to dosing
- •·Taking prescription-only laxatives (subjects using OTC-available products on a daily basis will be asked to stop medication 10 days prior to screening medical, subjects using OTC-available products less than 3 times per week will be asked to stop using these products at the time of recruitment/consenting).
- •·Meeting criteria for IBS (see below)
- •·Rectal bleeding or positive test for Faecal occult blood at screening
- •·Recent weight loss or change in bowel habit
- •·Known or suspected bowel perforation or risk of perforation, ileus or suspicion of intestinal obstruction
- •·Prior GI surgery
- •·Severe inflammatory bowel conditions (such as ulcerative colitis, Crohn's disease and toxic megacolon) and symptomatic stenosis
- •·Painful abdominal symptoms of indeterminate cause
- •·History of peptic ulcer (occasional heartburn or non-specific dyspepsia is acceptable).
- •·Phenylketonuria
- •·Sodium restricted diet (e.g. for heart failure or hypertension), reduced kidney function or controlled potassium diet
- •·Hypersensitivity to the active substance or to any of the excipients of the product
- •·Lactating/breastfeeding (female patients only)
- •Diagnostic criteria for IBSAt least 12 weeks, which need not be consecutive, in the preceding 12 months of abdominal discomfort and pain that has two of three features:1.Relieved with defecation; and/or2.Onset associated with change in frequency of stool3.Onset associated with change in form (appearance) of stool
Investigators
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