Constipation Associated With Irritable Bowel Syndrome (IBS-C)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00796354
• Date of registration: 21/11/2008
• Prospective Registration: No
• Primary sponsor: Norgine
• Public title: Constipation Associated With Irritable Bowel Syndrome (IBS-C)
• Scientific title: 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 Associated With Irritable Bowel Syndrome (IBS)
• Date of first enrolment: November 2008
• Target sample size: 210
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00796354
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Czech Republic, France, Germany, Italy, Poland, Sweden, United Kingdom

Contacts

• Name: Mike Geraint, MD
• Affiliation: Norgine Pharmaceuticals Ltd

• Name: Roger Chapman, MD
• Affiliation: Oxford University Hospitals NHS Trust

Key inclusion & exclusion criteria

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 Randomisation Visit.

- 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.

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, 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 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Constipation

Intervention(s)

Drug: Sugar Pill

Drug: MOVICOL

Primary Outcome(s)

To evaluate the efficacy and safety of Movicol® versus placebo in the relief of constipation associated with IBS. [Time Frame: April 2009]

Secondary Outcome(s)

To evaluate the effect of treatment on other symptoms of IBS. [Time Frame: April 2009]

To evaluate the effect of treatment on patient's Quality Of Life (QOL). [Time Frame: April 2009]

Secondary ID(s)

NRL920-01/2008 (IBSc)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors