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Constipation Associated With Irritable Bowel Syndrome (IBS-C)

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00796354
First received: November 21, 2008
Last updated: February 15, 2010
Last verified: February 2010
  Purpose

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


Condition Intervention Phase
Constipation
Drug: MOVICOL
Drug: Sugar Pill
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


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 ]

Enrollment: 210
Study Start Date: November 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NRL920 Drug: MOVICOL
sealed laminated sachet, 1 - 3 sachets daily for 4 weeks
Other Names:
  • Macrogol (PEG) 3350
  • sodium chloride
  • sodium bicarbonate
  • potassium chloride
  • acesulfame potassium
  • lemon-lime flavouring
Placebo Comparator: Placebo Drug: Sugar Pill
sealed laminated sachet, 1 - 3 sachets daily for 4 weeks
Other Names:
  • Sucrose
  • lemon and lime flavour

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796354

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

Publications:
Responsible Party: Dr Mike Geraint, Norgine Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT00796354     History of Changes
Other Study ID Numbers: NRL920-01/2008 (IBSc)
Study First Received: November 21, 2008
Last Updated: February 15, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Norgine:
Constipation
Irritable Bowel Syndrome

Additional relevant MeSH terms:
Constipation
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 27, 2014