An Explorative Trial to Evaluate the Pharmacodynamic Effect of M0003 on Reflux Parameters in Refractory GERD Patients
This study has been completed.
Sponsor:
Movetis
Information provided by (Responsible Party):
Movetis
ClinicalTrials.gov Identifier:
NCT01370863
First received: May 31, 2011
Last updated: July 23, 2012
Last verified: October 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this trial is to investigate the pharmacodynamic effect on reflux parameters of M0003 (SPD557) tablets (0.5 mg t.i.d., on top of PPI treatment) in patients with Gastroesophageal Reflux Disease (GERD) with persistent symptoms despite taking a stable dose of proton pump inhibitors. Additionally the effect on symptoms will be explored and safety and tolerability will be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Disease |
Drug: M0003 (SPD557) Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | An Explorative, Randomized, Placebo-controlled, DB, Parallel-group Trial, to Evaluate the Pharmacodynamic Effect of M0003 on Reflux Parameters in Subjects With GERD & With Persistent Symptoms Despite Taking a Stable Dose of PPIs |
Resource links provided by NLM:
Further study details as provided by Movetis:
Primary Outcome Measures:
- 24-h pH/MII monitoring (pre- and post- treatment) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Daily diary symptom scores for heartburn and regurgitation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Pagi-Sym questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 67 |
| Study Start Date: | December 2010 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: M0003 (SPD557) |
Drug: M0003 (SPD557)
0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment
|
| Placebo Comparator: Placebo |
Drug: placebo
matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Written ICF signed voluntarily before the first trial related activity.
- Subjects with a history of GERD symptoms (i.e., heartburn and/or regurgitation) during the last 6 months
- Subjects on a stable dose of PPIs, compliant for at least 6 weeks prior to screening.
- ≥3 days per week with heartburn and/or regurgitation symptoms of at least moderate severity and a minimum of 25 liquid containing reflux events over 24h (pH/MII monitoring).
Exclusion criteria:
- Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects with major GI disorders.
- Presence of severe and clinically uncontrolled cardiovascular, liver or lung disease, neurologic, cancer or AIDS.
- Alarm symptoms suggestive of malignancies or organic disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370863
Locations
| Belgium | |
| CUB Hôpital Erasme | |
| Brussels, Bruxelles, Belgium, 1070 | |
| Cliniques universitaires Saint Luc | |
| Bruxelles, Belgium, 1200 | |
| UZ Leuven, Belgium | |
| Leuven, Belgium, 3000 | |
| France | |
| CHU de Bordeaux - Hôpital Saint André | |
| Bordeaux Cedex, France, 33075 | |
| CHU de Lyon - Groupement Hospitalier Edouard Herriot | |
| Lyon, France, 69437 | |
| Hôtel Dieu - CHU de Nantes | |
| Nantes Cedex 1, France, 44093 | |
| Germany | |
| Klinikum Garmisch-Partenkirchen GmbH | |
| Garmisch-Partenkirchen, Germany, 82467 | |
| Otto-von-Guericke University | |
| Magdeburg, Germany, 39120 | |
| Netherlands | |
| Academisch Medisch Centrum (AMC) | |
| Amsterdam, Netherlands, 1105 AZ | |
| Switzerland | |
| Inselspital Bern (Bern University Hopsital) | |
| Bern, Switzerland, BHH D140 | |
| Kantonsspital St. Gallen | |
| St. Gallen, Switzerland, 9007 | |
| University Hospital Zurich | |
| Zurich, Switzerland, CH-8091 | |
| United Kingdom | |
| Addenbrooke's Hospital | |
| Cambridge, United Kingdom, CB2 0QQ | |
| Wingate Institute of Neurogastroenterology | |
| London, United Kingdom, E12AJ | |
| Queen's Medical Center (Nottingham University Hospital) | |
| Nottingham, United Kingdom, NG7 2UH | |
Sponsors and Collaborators
Movetis
Investigators
| Study Director: | An Rykx, PhD | Shire-Movetis |
| Principal Investigator: | Prof. Jan Tack, M.D. | KUL, Herestraat 49, 3000 Leuven |
More Information
No publications provided
| Responsible Party: | Movetis |
| ClinicalTrials.gov Identifier: | NCT01370863 History of Changes |
| Other Study ID Numbers: | M0003-C202 |
| Study First Received: | May 31, 2011 |
| Last Updated: | July 23, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Switzerland: Federal Office of Public Health Germany: Federal Institute for Drugs and Medical Devices United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Movetis:
|
GERD Gastroesophageal reflux disease M0003 SPD557 Proton pump inhibitors |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases |
Digestive System Diseases Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013