A double-blind, randomised, parallel group pilot study to compare macrogol 3350 + electrolytes versus placebo in the overnight relief of constipation - Transipeg

Phase 1

• Conditions: Constipation; MedDRA version: 6.0Classification code 10010774

• Registration Number: EUCTR2005-006111-47-IE
• Lead Sponsor: McNeil Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-04
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the short-term efficacy of Transipeg in the treatment of constipation;Secondary Objective: Recording of adverse events;Primary end point(s): Primary: Time to passage of first stool post initial dose