Constipation Clinical Trial
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)
Verified date | February 2010 |
Source | Norgine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Multi-centre, double-blind, randomised, placebo-controlled, parallel group study.
Status | Completed |
Enrollment | 210 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Czech Republic | Gastroenterologie s.r.o. | Hradec Králové | |
Czech Republic | EGK.s.r.o, Sanatorium sv. Anny | Praha | |
Czech Republic | Orlickoustecká Nemocnice a.s. | Ústi Nad Orlicí | |
France | Hôpital Hotel Dieu | Clermont-Ferrand | |
France | Hôpital Archet II | Nice | |
France | Hôpital Charles Nicolles | Rouen | |
Germany | Martin-Luther-Krankenhaus-Betriebs-GmbH | Berlin | |
Germany | Gastroenterologische Gemeinschaftspraxis | Münster | |
Germany | Facharztpraxis für Innere Medizin | Wiesbaden | |
Italy | Policlinico S. Orsola Malpighi | Bologna | |
Italy | Università degli Studi di Genova | Genova | |
Italy | Università degli Studi di Palermo | Palermo | |
Italy | Università La Sapienza | Roma | |
Poland | Slaskie Centrum Osteoporozy | Katowice | |
Poland | Centrum Onkologii ul.Rentgena 5 | Warsaw | |
Poland | Prosen SMO | Warszawa | |
Poland | Katedra i Klinika Gastroenterologii i Hepatologii | Wroclaw | |
Sweden | Sodra Alvsborgs Hospital (SAS) | Borås | |
Sweden | Karolinska University Hospital Solna | Stockholm | |
United Kingdom | St Marks Hospital | Harrow | |
United Kingdom | John Radcliffe Hospital | Oxford |
Lead Sponsor | Collaborator |
---|---|
Norgine |
Czech Republic, France, Germany, Italy, Poland, Sweden, United Kingdom,
Attar A, Lémann M, Ferguson A, Halphen M, Boutron MC, Flourié B, Alix E, Salmeron M, Guillemot F, Chaussade S, Ménard 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the efficacy and safety of Movicol® versus placebo in the relief of constipation associated with IBS. | April 2009 | ||
Secondary | To evaluate the effect of treatment on other symptoms of IBS. | April 2009 | ||
Secondary | To evaluate the effect of treatment on patient's Quality Of Life (QOL). | April 2009 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Recruiting |
NCT06292949 -
Clinical Study of Resistant Starch in Improving Constipation
|
N/A | |
Recruiting |
NCT04132661 -
MRI Assessment of Mode of Action of Bisacodyl, Single Dose
|
Phase 4 | |
Completed |
NCT02726295 -
The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study
|
Phase 4 | |
Terminated |
NCT02839889 -
Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation)
|
Phase 4 | |
Recruiting |
NCT02255747 -
Anal Dilatation for Infants and Children With Constipation
|
N/A | |
Completed |
NCT02246647 -
Biomarkers for Intestinal Permeability in Patients With Constipation
|
||
Completed |
NCT01566409 -
Maintenance Treatment for Children With Constipation
|
N/A | |
Completed |
NCT01710579 -
Normal Values in Ano-rectal 3D High Resolution Manometry
|
N/A | |
Completed |
NCT01695915 -
Diurnal Variation in Rectal Diameter
|
N/A | |
Completed |
NCT02658201 -
Ultrafast MRI Imaging to Exclude Constipation
|
N/A | |
Completed |
NCT02863848 -
Effect of Inulin-type Fructans on Constipated Children.
|
N/A | |
Completed |
NCT01438567 -
A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy
|
Phase 3 | |
Completed |
NCT01411501 -
Efficacy and Safety of Acupuncture for Functional Constipation
|
Phase 3 | |
Completed |
NCT01474499 -
A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation
|
Phase 3 | |
Completed |
NCT00931853 -
Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).
|
Phase 3 | |
Completed |
NCT01170039 -
The Effectiveness of Lubiprostone in Constipated Diabetics
|
Phase 4 | |
Active, not recruiting |
NCT02442115 -
Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
|
||
Completed |
NCT00994851 -
Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.
|
Phase 3 | |
Terminated |
NCT01003249 -
Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
|
Phase 4 |