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Constipation Associated With Irritable Bowel Syndrome (IBS-C)
This study is currently recruiting participants.
Verified by Norgine, December 2008
Sponsored by: Norgine
Information provided by: Norgine
ClinicalTrials.gov Identifier: NCT00796354
  Purpose

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


Condition Intervention Phase
Constipation
Drug: MOVICOL
Drug: Sugar Pill
Phase III

MedlinePlus related topics: Constipation
Drug Information available for: Sodium chloride Sucrose Chlorides Potassium chloride Sodium bicarbonate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Norgine:

Primary Outcome Measures:
  • To evaluate the efficacy and safety of Movicol® versus placebo in the relief of constipation associated with IBS. [ Time Frame: April 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effect of treatment on other symptoms of IBS. [ Time Frame: April 2009 ] [ Designated as safety issue: No ]
  • To evaluate the effect of treatment on patient's Quality Of Life (QOL). [ Time Frame: April 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: November 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
NRL920: Active Comparator Drug: MOVICOL
sealed laminated sachet, 1 - 3 sachets daily for 4 weeks
Placebo: Placebo Comparator Drug: Sugar Pill
sealed laminated sachet, 1 - 3 sachets daily for 4 weeks

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796354

Contacts
Contact: Deborah Jones djones3@norgine.com

Locations
Czech Republic
EGK.s.r.o, Sanatorium sv. Anny Active, not recruiting
Praha, Czech Republic, 130 00
Orlickoustecká Nemocnice a.s. Active, not recruiting
Ústi nad Orlicí, Czech Republic, 562 18
Gastroenterologie s.r.o. Active, not recruiting
Hradec Králové, Czech Republic, 500 02
France
Hôpital Archet II Active, not recruiting
Nice, France, 06200
Hôpital Charles Nicolles Active, not recruiting
Rouen, France, 76031
Hôpital Hotel Dieu Active, not recruiting
Clermont-Ferrand, France, 63058
Germany
Martin-Luther-Krankenhaus-Betriebs-GmbH Active, not recruiting
Berlin, Germany, 14193
Gastroenterologische Gemeinschaftspraxis Active, not recruiting
Münster, Germany, 48159
Facharztpraxis für Innere Medizin Active, not recruiting
Wiesbaden, Germany, 65185
Italy
Università La Sapienza Active, not recruiting
Roma, Italy, 00162
Policlinico S. Orsola Malpighi Recruiting
Bologna, Italy, 40138
Contact: Vincenzo Stanghellini, MD     +39 051 6364 101     v.stanghellini@unibo.it    
Principal Investigator: Vincenzo Stanghellini, MD            
Università degli Studi di Genova Active, not recruiting
Genova, Italy, 6 - 16132
Università degli Studi di Palermo Active, not recruiting
palermo, Italy, 129 - 90127
Poland
Centrum Onkologii ul.Rentgena 5 Active, not recruiting
Warsaw, Poland, 02-781
Katedra i Klinika Gastroenterologii i Hepatologii Active, not recruiting
Wroclaw, Poland, 50-556
Prosen SMO Active, not recruiting
Warszawa, Poland, 01-231
Slaskie Centrum Osteoporozy Active, not recruiting
Katowice, Poland, 40-084
Sweden
Karolinska University Hospital Solna Active, not recruiting
Stockholm, Sweden, SE-171-76
Sodra Alvsborgs Hospital (SAS) Active, not recruiting
Borås, Sweden, SE-176-65
United Kingdom
John Radcliffe Hospital Active, not recruiting
Oxford, United Kingdom, OX3 9DU
St Marks Hospital Active, not recruiting
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Norgine
Investigators
Principal Investigator: Roger Chapman, MD John Radcliffe Hospital
Study Director: Mike Geraint, MD Norgine Pharmaceuticals Ltd
  More Information

Publications:
Responsible Party: Norgine Pharmaceuticals Ltd ( Dr Mike Geraint )
Study ID Numbers: NRL920-01/2008 (IBSc)
Study First Received: November 21, 2008
Last Updated: December 10, 2008
ClinicalTrials.gov Identifier: NCT00796354  
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Norgine:
Constipation
Irritable Bowel Syndrome

Study placed in the following topic categories:
Signs and Symptoms
Digestive System Diseases
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Colonic Diseases
Irritable Bowel Syndrome
Constipation
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 15, 2009