Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Norgine |
---|---|
Information provided by: | Norgine |
ClinicalTrials.gov Identifier: | NCT00796354 |
Multi-centre, double-blind, randomised, placebo-controlled, parallel group study.
Condition | Intervention | Phase |
---|---|---|
Constipation |
Drug: MOVICOL Drug: Sugar Pill |
Phase III |
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) |
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
|
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Deborah Jones | djones3@norgine.com |
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 |
Principal Investigator: | Roger Chapman, MD | John Radcliffe Hospital |
Study Director: | Mike Geraint, MD | Norgine Pharmaceuticals Ltd |
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 |
Constipation Irritable Bowel Syndrome |
Signs and Symptoms Digestive System Diseases Signs and Symptoms, Digestive Gastrointestinal Diseases Colonic Diseases |
Irritable Bowel Syndrome Constipation Intestinal Diseases Colonic Diseases, Functional |
Pathologic Processes Disease Syndrome |