Esophageal Hypersensitivity Study in Healthy Volunteers

Phase 1

Completed

• Conditions: Pain; Esophageal Sensitivity
• Interventions: Drug: AZD1386; Drug: Placebo

• Registration Number: NCT00711048
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-07
• Study First Posted: 2008-07-08
• Study Completion: 2009-07
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-27
• Last Update Posted: 2009-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD1386	30 mg, oral, single dose
2	AZD1386	95 mg, oral, single dose
3	Placebo	Oral solution, single dose

Primary Outcome Measures

Name	Time	Method
VAS scale and clock	Several occasions during the study days

Secondary Outcome Measures

Name	Time	Method
VAS scale and pressure, VAS scale and current, VAS scale and acid volume	Several occasions during the study days
Pharmacokinetic variables	Several occasions during the study days
Safety variables (adverse events, blood pressure, safety lab, ECG and body temperature)	Several occasions during the study days

Trial Locations

Locations (1)

Research Site; 🇸🇪 Goteborg, Sweden