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Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI

NCT01005251 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 661

Last updated 2011-04-25

Study results available
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Summary

This study is being carried out to see whether AZD3355 is an effective treatment as an add-on to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another goal of the study is to examine which of the investigated doses of AZD3355 is optimal for treatment of these patients. This study will also measure levels of drug in the blood and see how well it is tolerated.

Conditions

  • Gastroesophageal Reflux Disease
  • Heartburn
  • Regurgitation

Interventions

DRUG

lesogaberan (AZD3355)

60 mg, oral, capsules, bid for 4 w

DRUG

lesogaberan (AZD3355)

120 mg, oral, capsules, bid for 4 w

DRUG

lesogaberan (AZD3355)

180 mg, oral, capsules, bid for 4 w

DRUG

lesogaberan (AZD3355)

240 mg, oral, capsules, bid for 4 w

DRUG

Placebo

oral,capsules, bid for 4 w

Sponsors & Collaborators

Principal Investigators

  • Debra Silberg, MD · AstraZeneca

  • Nicholas Shaheen, MD, MPH · UNC Hospitals, 4141Chapel Hill, NC 27599 USA

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
2009-10-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT01005251 on ClinicalTrials.gov