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An Explorative Trial to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Refractory GERD Patients

NCT01370863 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2021-06-10

Study results available
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Summary

The purpose of this trial is to investigate the pharmacodynamic effect on reflux parameters of 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.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DRUG

SPD557

0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment

DRUG

placebo

matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-02
Primary Completion
2012-05-29
Completion
2012-05-29

Countries

  • Belgium
  • France
  • Germany
  • Netherlands
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01370863 on ClinicalTrials.gov