TLESR-impedance Study in Patients

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Reflux Episodes

Treatments: Drug: AZD3355; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00743444

D9120C00020

Details and patient eligibility

About

The purpose of the study is to compare frequency and content of reflux episodes in patients with gastroesophageal reflux disease.

Enrollment: 27 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of written consent
• GERD patients, age 18-70 years, females must be postmenopausal or surgically sterilised
• 6 months history of GERD and incomplete response to PPI treatment

Exclusion criteria

• Insufficient symptom burden of the reflux disease evaluated by questionnaires
• S-creatinine >1.2 times upper limit of normal
• History of heart disease
• Prior surgery of the upper GI tract

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

AZD3355

Treatment:

Drug: AZD3355

2

Placebo Comparator group

Treatment:

Drug: Placebo