Esophageal Hypersensitivity Study in Patients With Gastroesophageal Reflux Disease (GERD)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Sensitivity in Esophagus

Treatments: Drug: AZD1386; Drug: Placebo to AZD1386

Study type: Interventional

Funder types: Industry

Identifiers

NCT01019928

D9127C00002

2008-007420-26

Details and patient eligibility

About

The purpose of the study is to compare sensitivity of visceral pain in the esophagus using different pain stimuli.

Enrollment: 14 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of signed informed consent form
• BMI 18.5-35.0, inclusive
• Continuous PPI treatment for GERD during the last 4 weeks

Exclusion criteria

• Patients that have not experienced any GERD symptoms improvement at all after PPI treatment
• Unstable or clinically significant disorders including cardiovascular, respiratory, renal, hepatic, metabolic, psychiatric, other gastrointestinal and esophageal disorders besides GERD
• Prior surgery of the upper GI tract

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

14 participants in 2 patient groups

First AZD1386, then washout, then placebo

Experimental group

Treatment:

Drug: Placebo to AZD1386

Drug: AZD1386

First placebo, then washout, then AZD1386

Experimental group

Treatment:

Drug: Placebo to AZD1386

Drug: AZD1386