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

AstraZeneca logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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