Constipation Associated With Irritable Bowel Syndrome (IBS-C)

NCT00796354 | Completed Phase 3

• 1 other identifier: NRL920-01/2008 (IBSc)
• Study Type: interventional
• Target: 210
• Locations: 7 countries
• Sites: 21

Brief Summary

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

Conditions

Constipation

Keywords

Constipation; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy and safety of Movicol® versus placebo in the relief of constipation associated with IBS.

  April 2009

Secondary Outcomes (2)

• 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

Study Arms (2)

NRL920

ACTIVE COMPARATOR

Drug: MOVICOL

Placebo

PLACEBO COMPARATOR

Drug: Sugar Pill

Interventions

MOVICOL DRUG

sealed laminated sachet, 1 - 3 sachets daily for 4 weeks

Also known as: Macrogol (PEG) 3350, sodium chloride, sodium bicarbonate, potassium chloride, acesulfame potassium, lemon-lime flavouring

NRL920

Sugar Pill DRUG

sealed laminated sachet, 1 - 3 sachets daily for 4 weeks

Also known as: Sucrose, lemon and lime flavour

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norgine: lead

Study Sites (21)

Gastroenterologie s.r.o.

Hradec Králové, 500 02, Czechia

Location

EGK.s.r.o, Sanatorium sv. Anny

Prague, 130 00, Czechia

Location

Orlickoustecká Nemocnice a.s.

Ústi Nad Orlicí, 562 18, Czechia

Location

Hôpital Hotel Dieu

Clermont-Ferrand, 63058, France

Location

Hôpital Archet II

Nice, 06200, France

Location

Hôpital Charles Nicolles

Rouen, 76031, France

Location

Martin-Luther-Krankenhaus-Betriebs-GmbH

Berlin, 14193, Germany

Location

Gastroenterologische Gemeinschaftspraxis

Münster, 48159, Germany

Location

Facharztpraxis für Innere Medizin

Wiesbaden, 65185, Germany

Location

Policlinico S. Orsola Malpighi

Bologna, 40138, Italy

Location

Università degli Studi di Genova

Genova, 6 - 16132, Italy

Location

Università degli Studi di Palermo

Palermo, 129 - 90127, Italy

Location

Università La Sapienza

Roma, 00162, Italy

Location

Slaskie Centrum Osteoporozy

Katowice, 40-084, Poland

Location

Prosen SMO

Warsaw, 01-231, Poland

Location

Centrum Onkologii ul.Rentgena 5

Warsaw, 02-781, Poland

Location

Katedra i Klinika Gastroenterologii i Hepatologii

Wroclaw, 50-556, Poland

Location

Sodra Alvsborgs Hospital (SAS)

Borås, SE-176-65, Sweden

Location

Karolinska University Hospital Solna

Stockholm, SE-171-76, Sweden

Location

St Marks Hospital

Harrow, HA1 3UJ, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 9895382 BACKGROUND

MeSH Terms

Conditions

Constipation; Irritable Bowel Syndrome

Interventions

Polyethylene Glycols; Sodium Chloride; Sodium Bicarbonate; Potassium Chloride; acetosulfame; Sugars; Sucrose; lime

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Potassium Compounds; Carbohydrates; Disaccharides; Oligosaccharides; Polysaccharides

Study Officials

• Roger Chapman, MD

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

• Mike Geraint, MD

  Norgine Pharmaceuticals Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 24, 2008
• Study Start: November 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: February 17, 2010

Record last verified: 2010-02

Locations

IT (4); PL (4); CZ (3); GB (2); SE (2); FR (3); DE (3)