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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

661 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroesophageal Reflux Disease Heartburn Regurgitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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60 mg

PPI+lesogaberan (AZD3355) 60 mg bid

Group Type EXPERIMENTAL

lesogaberan (AZD3355)

Intervention Type DRUG

60 mg, oral, capsules, bid for 4 w

120 mg

PPI+lesogaberan (AZD3355) 120 mg bid

Group Type EXPERIMENTAL

lesogaberan (AZD3355)

Intervention Type DRUG

120 mg, oral, capsules, bid for 4 w

180 mg

PPI+lesogaberan (AZD3355) 180 mg bid

Group Type EXPERIMENTAL

lesogaberan (AZD3355)

Intervention Type DRUG

180 mg, oral, capsules, bid for 4 w

240 mg

PPI+lesogaberan (AZD3355) 240 mg bid

Group Type EXPERIMENTAL

lesogaberan (AZD3355)

Intervention Type DRUG

240 mg, oral, capsules, bid for 4 w

Placebo

PPI+ Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral,capsules, bid for 4 w

Interventions

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lesogaberan (AZD3355)

60 mg, oral, capsules, bid for 4 w

Intervention Type DRUG

lesogaberan (AZD3355)

120 mg, oral, capsules, bid for 4 w

Intervention Type DRUG

lesogaberan (AZD3355)

180 mg, oral, capsules, bid for 4 w

Intervention Type DRUG

lesogaberan (AZD3355)

240 mg, oral, capsules, bid for 4 w

Intervention Type DRUG

Placebo

oral,capsules, bid for 4 w

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No