Clinical trial NCT00796354: Constipation Associated With Irritable Bowel Syndrome (IBS-C)
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation
Keywords: Constipation
Irritable Bowel Syndrome
Lead sponsor: Norgine
Sponsor class: INDUSTRY
First posted: 2008-11-24
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multi-centre, double-blind, randomised, placebo-controlled, parallel group study.

Detailed description: Patients will be treated for 28 days, with clinical assessments carried out over 2 visits. Follow-up will be performed via telephone at a specific interval during the study to determine the outcome of unresolved AEs, any new drug-related AEs or any pregnancies. During the run-in period and the treatment phase, patients are prohibited from taking prescription or over the counter (OTC) laxative medication or constipating medications. Prescription and OTC medications not related to constipation are permitted and must be fully documented, but any changes (e.g., dosage, regimen) are to be limited as much as possible.

Eligibility 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.

Primary outcomes:
measure: To evaluate the efficacy and safety of Movicol® versus placebo in the relief of constipation associated with IBS.
timeFrame: April 2009
Secondary outcomes:
measure: To evaluate the effect of treatment on other symptoms of IBS.
timeFrame: April 2009
measure: To evaluate the effect of treatment on patient's Quality Of Life (QOL).
timeFrame: April 2009
Other outcomes:
Locations:
city: Hradec Králové
country: Czech Republic
facility: Gastroenterologie s.r.o.
city: Praha
country: Czech Republic
facility: EGK.s.r.o, Sanatorium sv. Anny
city: Ústi Nad Orlicí
country: Czech Republic
facility: Orlickoustecká Nemocnice a.s.
city: Clermont-Ferrand
country: France
facility: Hôpital Hotel Dieu
city: Nice
country: France
facility: Hôpital Archet II
city: Rouen
country: France
facility: Hôpital Charles Nicolles
city: Berlin
country: Germany
facility: Martin-Luther-Krankenhaus-Betriebs-GmbH
city: Münster
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis
city: Wiesbaden
country: Germany
facility: Facharztpraxis für Innere Medizin
city: Bologna
country: Italy
facility: Policlinico S. Orsola Malpighi
city: Genova
country: Italy
facility: Università degli Studi di Genova
city: Palermo
country: Italy
facility: Università degli Studi di Palermo
city: Roma
country: Italy
facility: Università La Sapienza
city: Katowice
country: Poland
facility: Slaskie Centrum Osteoporozy
city: Warsaw
country: Poland
facility: Centrum Onkologii ul.Rentgena 5
city: Warszawa
country: Poland
facility: Prosen SMO
city: Wroclaw
country: Poland
facility: Katedra i Klinika Gastroenterologii i Hepatologii
city: Borås
country: Sweden
facility: Sodra Alvsborgs Hospital (SAS)
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
city: Harrow
country: United Kingdom
facility: St Marks Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Roger Chapman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norgine Pharmaceuticals Ltd
name: Mike Geraint, MD
role: STUDY_DIRECTOR
References:
citation: Attar A, Lemann M, Ferguson A, Halphen M, Boutron MC, Flourie B, Alix E, Salmeron M, Guillemot F, Chaussade S, Menard AM, Moreau J, Naudin G, Barthet M. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut. 1999 Feb;44(2):226-30. doi: 10.1136/gut.44.2.226.