A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: AZD3355; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01043185

D9120C00032

Details and patient eligibility

About

The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.

Enrollment: 27 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provide informed consent
• History of GERD with persistent symptoms despite treatment with PPI
• Otherwise normal physical health

Exclusion criteria

• History of GERD with symptoms that has not improved at all during treatment with PPI
• Prior surgery of the upper gastrointestinal tract
• History of significant heart disease, cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric or gastrointestinal disorders besides GERD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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27 participants in 5 patient groups, including a placebo group

A

Experimental group

Description:

AZD3355 30 mg

Treatment:

Drug: AZD3355

Drug: AZD3355

Drug: AZD3355

Drug: AZD3355

B

Experimental group

Description:

AZD3355 90 mg

Treatment:

Drug: AZD3355

Drug: AZD3355

Drug: AZD3355

Drug: AZD3355

C

Experimental group

Description:

AZD3355 120 mg

Treatment:

Drug: AZD3355

Drug: AZD3355

Drug: AZD3355

Drug: AZD3355

D

Experimental group

Description:

AZD3355 240 mg

Treatment:

Drug: AZD3355

Drug: AZD3355

Drug: AZD3355

Drug: AZD3355

E

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo