Constipation Associated With Irritable Bowel Syndrome (IBS-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00796354
Recruitment Status : Completed
First Posted : November 24, 2008
Last Update Posted : February 17, 2010
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Brief Summary:
Multi-centre, double-blind, randomised, placebo-controlled, parallel group study.

Condition or disease Intervention/treatment Phase
Constipation Drug: MOVICOL Drug: Sugar Pill Phase 3

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  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : November 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. To evaluate the efficacy and safety of Movicol® versus placebo in the relief of constipation associated with IBS. [ Time Frame: April 2009 ]

Secondary Outcome Measures :
  1. To evaluate the effect of treatment on other symptoms of IBS. [ Time Frame: April 2009 ]
  2. To evaluate the effect of treatment on patient's Quality Of Life (QOL). [ Time Frame: April 2009 ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00796354

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
Hôpital Hotel Dieu
Clermont-Ferrand, France, 63058
Hôpital Archet II
Nice, France, 06200
Hôpital Charles Nicolles
Rouen, France, 76031
Berlin, Germany, 14193
Gastroenterologische Gemeinschaftspraxis
Münster, Germany, 48159
Facharztpraxis für Innere Medizin
Wiesbaden, Germany, 65185
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
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
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
Principal Investigator: Roger Chapman, MD Oxford University Hospitals NHS Trust
Study Director: Mike Geraint, MD Norgine Pharmaceuticals Ltd

Responsible Party: Dr Mike Geraint, Norgine Pharmaceuticals Ltd Identifier: NCT00796354     History of Changes
Other Study ID Numbers: NRL920-01/2008 (IBSc)
First Posted: November 24, 2008    Key Record Dates
Last Update Posted: February 17, 2010
Last Verified: February 2010

Keywords provided by Norgine:
Irritable Bowel Syndrome

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