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

November 21, 2008
February 15, 2010
November 2008
February 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00796354 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Constipation Associated With Irritable Bowel Syndrome (IBS-C)
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)

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Constipation
  • 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
  • Drug: Sugar Pill
    sealed laminated sachet, 1 - 3 sachets daily for 4 weeks
    Other Names:
    • Sucrose
    • lemon and lime flavour
  • Active Comparator: NRL920
    Intervention: Drug: MOVICOL
  • Placebo Comparator: Placebo
    Intervention: Drug: Sugar Pill
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   France,   Germany,   Italy,   Poland,   Sweden,   United Kingdom
 
NCT00796354
NRL920-01/2008 (IBSc)
No
Dr Mike Geraint, Norgine Pharmaceuticals Ltd
Norgine
Not Provided
Principal Investigator: Roger Chapman, MD Oxford University Hospitals NHS Trust
Study Director: Mike Geraint, MD Norgine Pharmaceuticals Ltd
Norgine
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP