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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NRL920 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOVICOL | Drug | sealed laminated sachet, 1 - 3 sachets daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy and safety of Movicol® versus placebo in the relief of constipation associated with IBS. | April 2009 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of treatment on other symptoms of IBS. | April 2009 | |
| To evaluate the effect of treatment on patient's Quality Of Life (QOL). | April 2009 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Chapman, MD | Oxford University Hospitals NHS Trust | Principal Investigator |
| Mike Geraint, MD | Norgine Pharmaceuticals Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterologie s.r.o. | Hradec Králové | 500 02 | Czechia | |||
| EGK.s.r.o, Sanatorium sv. Anny |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9895382 | Background | 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. doi: 10.1136/gut.44.2.226. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 31, 2012 | |
| Reset | Oct 1, 2012 | |
| Release | Sep 10, 2024 | |
| Reset | Nov 14, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 31, 2012 | Oct 1, 2012 | |||
| Sep 10, 2024 |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003109 | Colonic Diseases, Functional |
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D012965 | Sodium Chloride |
| D017693 | Sodium Bicarbonate |
| D011189 | Potassium Chloride |
| C006362 | acetosulfame |
| D000073893 | Sugars |
| D013395 | Sucrose |
| C016538 | lime |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Sugar Pill | Drug | sealed laminated sachet, 1 - 3 sachets daily for 4 weeks |
|
|
| Prague |
| 130 00 |
| Czechia |
| Orlickoustecká Nemocnice a.s. | Ústi Nad Orlicí | 562 18 | Czechia |
| Hôpital Hotel Dieu | Clermont-Ferrand | 63058 | France |
| Hôpital Archet II | Nice | 06200 | France |
| Hôpital Charles Nicolles | Rouen | 76031 | France |
| Martin-Luther-Krankenhaus-Betriebs-GmbH | Berlin | 14193 | Germany |
| Gastroenterologische Gemeinschaftspraxis | Münster | 48159 | Germany |
| Facharztpraxis für Innere Medizin | Wiesbaden | 65185 | Germany |
| Policlinico S. Orsola Malpighi | Bologna | 40138 | Italy |
| Università degli Studi di Genova | Genova | 6 - 16132 | Italy |
| Università degli Studi di Palermo | Palermo | 129 - 90127 | Italy |
| Università La Sapienza | Roma | 00162 | Italy |
| Slaskie Centrum Osteoporozy | Katowice | 40-084 | Poland |
| Prosen SMO | Warsaw | 01-231 | Poland |
| Centrum Onkologii ul.Rentgena 5 | Warsaw | 02-781 | Poland |
| Katedra i Klinika Gastroenterologii i Hepatologii | Wroclaw | 50-556 | Poland |
| Sodra Alvsborgs Hospital (SAS) | Borås | SE-176-65 | Sweden |
| Karolinska University Hospital Solna | Stockholm | SE-171-76 | Sweden |
| St Marks Hospital | Harrow | HA1 3UJ | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| Nov 14, 2024 |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D017680 | Potassium Compounds |
| D002241 | Carbohydrates |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |