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

March 29, 2011 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

661

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Have at least 6 months history of GERD
  • Continuously treated during the last 4 weeks before enrolment with daily optimized unchanged PPI therapy for any GERD indication

Exclusion Criteria:

  • Patients that have not experienced any GERD symptom improvement at all during PPI treatment
  • Prior surgery of the upper gastrointestinal tract.
  • Subject who have any of the following conditions or diseases: Heart disease, Angina, Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 60 mg
PPI+lesogaberan (AZD3355) 60 mg bid
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
Experimental: 120 mg
PPI+lesogaberan (AZD3355) 120 mg bid
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
Experimental: 180 mg
PPI+lesogaberan (AZD3355) 180 mg bid
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
Experimental: 240 mg
PPI+lesogaberan (AZD3355) 240 mg bid
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
Placebo Comparator: Placebo
PPI+ Placebo
Drug: Placebo
oral,capsules, bid for 4 w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation)
Time Frame: The 7 days before randomisation (baseline) and during 26-30 days of treatment

Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary.

(GERD = Gastroesophageal Reflux Disease)
The 7 days before randomisation (baseline) and during 26-30 days of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.
Time Frame: The 7 days before randomisation (baseline) and during 26-30 days of treatment

Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary

(GERD = Gastroesophageal Reflux Disease)
The 7 days before randomisation (baseline) and during 26-30 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Nicholas Shaheen, MD, MPH, UNC Hospitals, 4141Chapel Hill, NC 27599 USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 27, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (Estimate)

October 30, 2009

Study Record Updates

Last Update Posted (Estimate)

April 25, 2011

Last Update Submitted That Met QC Criteria

March 29, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9120C00019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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