Constipation Associated With Irritable Bowel Syndrome (IBS-C)

NCT ID: NCT00796354

Last Updated: 2010-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-02-28

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.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NRL920

Group Type: ACTIVE_COMPARATOR

MOVICOL

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Sugar Pill

Intervention Type: DRUG

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

Interventions

MOVICOL

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

Intervention Type: DRUG

Sugar Pill

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

Intervention Type: DRUG

Other Intervention Names

Macrogol (PEG) 3350; sodium chloride; sodium bicarbonate; potassium chloride; acesulfame potassium; lemon-lime flavouring; Sucrose; lemon and lime flavour

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norgine

INDUSTRY

Sponsor Role: lead

Responsible Party

Norgine Pharmaceuticals Ltd

Principal Investigators

Roger Chapman, MD

Role: PRINCIPAL_INVESTIGATOR

Oxford University Hospitals NHS Trust

Mike Geraint, MD

Role: STUDY_DIRECTOR

Norgine Pharmaceuticals Ltd

Locations

Gastroenterologie s.r.o.

Hradec Králové, , Czechia

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

Prague, , Czechia

Orlickoustecká Nemocnice a.s.

Ústi Nad Orlicí, , Czechia

Hôpital Hotel Dieu

Clermont-Ferrand, , France

Hôpital Archet II

Nice, , France

Hôpital Charles Nicolles

Rouen, , France

Martin-Luther-Krankenhaus-Betriebs-GmbH

Berlin, , Germany

Gastroenterologische Gemeinschaftspraxis

Münster, , Germany

Facharztpraxis für Innere Medizin

Wiesbaden, , Germany

Policlinico S. Orsola Malpighi

Bologna, , Italy

Università degli Studi di Genova

Genova, , Italy

Università degli Studi di Palermo

Palermo, , Italy

Università La Sapienza

Roma, , Italy

Slaskie Centrum Osteoporozy

Katowice, , Poland

Prosen SMO

Warsaw, , Poland

Centrum Onkologii ul.Rentgena 5

Warsaw, , Poland

Katedra i Klinika Gastroenterologii i Hepatologii

Wroclaw, , Poland

Sodra Alvsborgs Hospital (SAS)

Borås, , Sweden

Karolinska University Hospital Solna

Stockholm, , Sweden

St Marks Hospital

Harrow, , United Kingdom

John Radcliffe Hospital

Oxford, , United Kingdom

Countries

Czechia; France; Germany; Italy; Poland; Sweden; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 9895382 (View on PubMed)

Other Identifiers

NRL920-01/2008 (IBSc)

Identifier Type: -

Identifier Source: org_study_id