Esophageal Hypersensitivity Study in Healthy Volunteers

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Esophageal Sensitivity; Pain

Treatments: Drug: AZD1386; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00711048

D9127C00001

2008-000313-30

Details and patient eligibility

About

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

Enrollment: 45 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of written consent
• Clinically normal physical findings
• Sensitization potential

Exclusion criteria

• Clinically significant illness within 2 weeks prior to the first dose of investigational product
• History of clinically significant disease
• Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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45 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

30 mg, oral, single dose

Treatment:

Drug: AZD1386

2

Experimental group

Description:

95 mg, oral, single dose

Treatment:

Drug: AZD1386

3

Placebo Comparator group

Description:

Oral solution, single dose

Treatment:

Drug: Placebo