A Phase IIIb/IV, Multi-centre, Double-blind, Randomised, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Movicol with Placebo in Patients with Constipation - ND

• Conditions: Constipation associated with irritable bowel syndrome; MedDRA version: 9.1Level: SOCClassification code 10017947Term: Gastrointestinal disorders; MedDRA version: 9.1Level: HLGTClassification code 10017977Term: Gastrointestinal motility and defaecation conditions

• Registration Number: EUCTR2008-000550-12-IT
• Lead Sponsor: orgine Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Male and females aged 18 to 80 years inclusive. Written informed consent obtained. Females of child-bearing potential must employ an adequate* method of contraception and must undergo a pregnancy test at the Visit 2 (Randomisation Visit). (*The use of the combined oral pill, progestogen only pill, combined contraceptive patches, depot contraceptives or double barrier method all are acceptable as an adequate form of contraception) Willing, able and competent to complete the entire study and comply with study instructions. Patients > 50 years old have to have undergone a colonoscopy or computerised tomography (CT) after the onset of their IBS-C symptoms or within the last 5 years. Patient has diagnosed IBS-C using Rome III criteria for the last 3 months, with symptom onset at least 6 months prior to diagnosis. The Rome III criteria specifies IBS as recurrent abdominal pain or discomfort (?discomfort? means an uncomfortable sensation not described as pain) for at least 3 days per month in the last 3 months associated with 2 or more of the following: Improvement with defecation Onset associated with a change in the frequency of stool Onset associated with a change in form (appearance) of stool The subtype IBS-C is defined as hard or lumpy stools (Bristol Stool Chart type 1-2) for at least 25% of bowel movements and loose (mushy) or watery stools (Bristol Stool Chart type 6-7) for less than 25% of bowel movements. No symptoms of IBS-diarrhoea (IBS-D) or IBS-mixed (IBS-M) in the last 3 months. Less than 3 spontaneous bowel movements** during the last 7 days of the run-in period. (**a spontaneous bowel movement is defined as a bowel movement that occurs without the use of rescue medication or as any bowel movement occurring ≥ 24 hours after the use of rescue medication).
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

History or evidence of organic disease in the large bowel, intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract such as Crohn?s disease, complicated diverticulitis, ulcerative colitis, toxic megacolon and occlusive or subocclusive syndrome. Abdominal pain of unknown cause, not related to IBS. Previous major abdominal surgery. IBS subtype other than IBS-C. Known allergy to polyethylene glycol (PEG) 3350 or known hypersensitivity to any of the active substances. Laxative, drug or alcohol abuse (recent history or within previous 12 months). Pregnant or lactating females. Severe or acute disease within 2 weeks prior to the start of the study. Patients with type I or II diabetes. Use of other investigational drugs, prescribed or OTC medications affecting gastrointestinal function such as anticholinergics, prokinetics, drugs affecting motility (e.g., erythromycin), anthraquinones, opioids, ondansetron or other 5-HT3 antagonists. Incomplete Patient Diary Card during the run-in period. The occurrence of diarrhoea* during the run-in period. Patients with abnormal laboratory tests, proctoscopy /abdominal ultrasound, colonoscopy, sigmoidoscopy or CT that requires further investigation. Patients with any condition, which, in the Investigator?s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the results of the study. Participation in another clinical study of drugs or devices parallel to or less than 1 month before study entry, or previous participation in this study. Employees of the Investigator or study site with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, as well as family members of the employees or the Investigator. * Diarrhoea is defined as loose (mushy) or watery stools

Study & Design

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