Constipation Associated With Irritable Bowel Syndrome (IBS-C)

Constipation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00796354
• Other study ID #: NRL920-01/2008 (IBSc)
• Status: Completed
• Phase: Phase 3
• First received: November 21, 2008
• Last updated: February 15, 2010
• Start date: November 2008
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome

Intervention

Drug:
• MOVICOL
sealed laminated sachet, 1 - 3 sachets daily for 4 weeks
• Sugar Pill
sealed laminated sachet, 1 - 3 sachets daily for 4 weeks

Locations

Country	Name	City	State
Czech Republic	Gastroenterologie s.r.o.	Hradec Králové
Czech Republic	EGK.s.r.o, Sanatorium sv. Anny	Praha
Czech Republic	Orlickoustecká Nemocnice a.s.	Ústi Nad Orlicí
France	Hôpital Hotel Dieu	Clermont-Ferrand
France	Hôpital Archet II	Nice
France	Hôpital Charles Nicolles	Rouen
Germany	Martin-Luther-Krankenhaus-Betriebs-GmbH	Berlin
Germany	Gastroenterologische Gemeinschaftspraxis	Münster
Germany	Facharztpraxis für Innere Medizin	Wiesbaden
Italy	Policlinico S. Orsola Malpighi	Bologna
Italy	Università degli Studi di Genova	Genova
Italy	Università degli Studi di Palermo	Palermo
Italy	Università La Sapienza	Roma
Poland	Slaskie Centrum Osteoporozy	Katowice
Poland	Centrum Onkologii ul.Rentgena 5	Warsaw
Poland	Prosen SMO	Warszawa
Poland	Katedra i Klinika Gastroenterologii i Hepatologii	Wroclaw
Sweden	Sodra Alvsborgs Hospital (SAS)	Borås
Sweden	Karolinska University Hospital Solna	Stockholm
United Kingdom	St Marks Hospital	Harrow
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Norgine

Countries where clinical trial is conducted

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

References & Publications (1)

Attar A, Lémann M, Ferguson A, Halphen M, Boutron MC, Flourié B, Alix E, Salmeron M, Guillemot F, Chaussade S, Ménard 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy and safety of Movicol® versus placebo in the relief of constipation associated with IBS.		April 2009
Secondary	To evaluate the effect of treatment on other symptoms of IBS.		April 2009
Secondary	To evaluate the effect of treatment on patient's Quality Of Life (QOL).		April 2009