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Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shire-Movetis NV
ClinicalTrials.gov Identifier:
NCT01472939
First received: November 14, 2011
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

The aim of this study is to establish a dose-related effect of a selective 5-HT4 receptor agonist compared to placebo on residual symptoms (regurgitation with or without heartburn) in subjects with GERD who have persistent symptoms while on PPI therapy.


Condition Intervention Phase
Gastroesophageal Reflux Disease
 Drug: SSP-002358 (0.1 mg) + PPI
Drug: SSP-002358 (0.5 mg) + PPI
Drug: SSP-002358 (2.0 mg) + PPI
Drug: Placebo + PPI
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate Efficacy of a Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD) With Persistent Regurgitation With or Without Heartburn

Resource links provided by NLM:

MedlinePlus related topics: GERD Heartburn
U.S. FDA Resources

Further study details as provided by Shire-Movetis NV:

Primary Outcome Measures:
  • Percentage of regurgitation-free days compared to placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of heartburn-free days compared to placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 460
Study Start Date: February 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SSP-002358 (0.1 mg) + Proton Pump Inhibitor (PPI) Drug: SSP-002358 (0.1 mg) + PPI
0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI
Other Name: SPD557
Active Comparator: SSP-002358 (0.5 mg) + PPI Drug: SSP-002358 (0.5 mg) + PPI
0.5 mg tablet t.i.d. taken in addition to a PPI
Active Comparator: SSP-002358 (2.0 mg) + PPI Drug: SSP-002358 (2.0 mg) + PPI
2.0 mg tablet t.i.d. taken in addition to a PPI
Placebo Comparator: Placebo + PPI Drug: Placebo + PPI
Placebo t.i.d. taken in addition to a PPI

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written Informed Consent Form signed voluntarily before the first study-related activity.
  2. Aged between 18 and 70 years, inclusive.
  3. Subjects with a history of the cardinal symptoms of GERD (both heartburn and regurgitation) prior to PPI therapy.
  4. Subjects with symptoms of GERD for at least 6 months prior to the Screening Visit.
  5. Subjects who have persistent symptoms of regurgitation for 3 or more days over the past week with or without heartburn while on PPI.
  6. Subjects have at least some improvement to the symptom of heartburn while on PPI therapy.
  7. Subjects on PPI therapy for at least 8 weeks prior to the Screening Visit of which the last 4 weeks are on a stable labeled dose for any GERD indication according to the country label, where a change of PPI therapy would not impact the symptoms (twice-daily dosing of PPI is not allowed in the last 4 weeks)

Exclusion Criteria:

  1. Subjects who show no response to heartburn while on PPI therapy.
  2. Subjects with dyspepsia symptoms that are more predominant than their GERD symptoms (heartburn and/or regurgitation).
  3. Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects with major GI disorders.
  4. Presence of severe and clinically uncontrolled cardiovascular, liver, lung or neurologic disease, cancer or AIDS.
  5. Alarm symptoms suggestive of malignancies or organic disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472939

  Show 88 Study Locations
Sponsors and Collaborators
Shire-Movetis NV
Investigators
Principal Investigator: Nicholas Shaheen, MD, MPH Coordinating/Study PI
  More Information

No publications provided

Responsible Party: Shire-Movetis NV
ClinicalTrials.gov Identifier: NCT01472939     History of Changes
Other Study ID Numbers: SPD557-206, 2011-004388-62
Study First Received: November 14, 2011
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration

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 19, 2013