Constipation Associated With Irritable Bowel Syndrome (IBS-C)

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)

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

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Drug: MOVICOL; Drug: Sugar Pill

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.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czech Republic
  • Hradec Králové, Czech Republic, 500 02
    • Gastroenterologie s.r.o.
  • Praha, Czech Republic, 130 00
    • EGK.s.r.o, Sanatorium sv. Anny
  • Ústi Nad Orlicí, Czech Republic, 562 18
    • Orlickoustecká Nemocnice a.s.
• France
  • Clermont-Ferrand, France, 63058
    • Hopital Hotel Dieu
  • Nice, France, 06200
    • Hôpital ARCHET II
  • Rouen, France, 76031
    • Hôpital Charles Nicolles
• Germany
  • Berlin, Germany, 14193
    • Martin-Luther-Krankenhaus-Betriebs-GmbH
  • Münster, Germany, 48159
    • Gastroenterologische Gemeinschaftspraxis
  • Wiesbaden, Germany, 65185
    • Facharztpraxis für Innere Medizin
• Italy
  • Bologna, Italy, 40138
    • Policlinico S. Orsola Malpighi
  • Genova, Italy, 6 - 16132
    • Universita degli Studi di Genova
  • Palermo, Italy, 129 - 90127
    • Universita degli Studi di Palermo
  • Roma, Italy, 00162
    • Università La Sapienza
• Poland
  • Katowice, Poland, 40-084
    • Slaskie Centrum Osteoporozy
  • Warsaw, Poland, 02-781
    • Centrum Onkologii ul.Rentgena 5
  • Warszawa, Poland, 01-231
    • Prosen SMO
  • Wroclaw, Poland, 50-556
    • Katedra i Klinika Gastroenterologii i Hepatologii
• Sweden
  • Borås, Sweden, SE-176-65
    • Sodra Alvsborgs Hospital (SAS)
  • Stockholm, Sweden, SE-171-76
    • Karolinska University Hospital Solna
• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ
    • St Marks Hospital
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Sugar Pill; sealed laminated sachet, 1 - 3 sachets daily for 4 weeks; Other Names: Sucrose; lemon and lime flavour
Active Comparator: NRL920	Drug: MOVICOL; sealed laminated sachet, 1 - 3 sachets daily for 4 weeks; Other Names: sodium chloride; Macrogol (PEG) 3350; sodium bicarbonate; potassium chloride; acesulfame potassium; lemon-lime flavouring

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the effect of treatment on other symptoms of IBS.	April 2009
To evaluate the effect of treatment on patient's Quality Of Life (QOL).	April 2009

Collaborators and Investigators

• Sponsor: Norgine
• Investigators: Principal Investigator: Roger Chapman, MD, Oxford University Hospitals NHS Trust; Study Director: Mike Geraint, MD, Norgine Pharmaceuticals Ltd

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: November 21, 2008
• First Submitted That Met QC Criteria: November 21, 2008
• First Posted (Estimate): November 24, 2008

Study Record Updates

• Last Update Posted (Estimate): February 17, 2010
• Last Update Submitted That Met QC Criteria: February 15, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Constipation
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Constipation
• Other Study ID Numbers: NRL920-01/2008 (IBSc)