Esophageal Hypersensitivity Study in Healthy Volunteers

Pain Clinical Trial

Official title:

A Phase I, Two Centre, Double-blind, Randomized, Cross-over Study to Evaluate AZD1386 in Single Doses of 30 mg and 95 mg Compared to Placebo in a Multimodal Experimental Pain Model on Esophageal Sensitivity and Development of Sensitization in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711048
• Other study ID #: D9127C00001
• Secondary ID: 2008-000313-30
• Status: Completed
• Phase: Phase 1
• First received: July 7, 2008
• Last updated: August 27, 2009
• Start date: June 2008
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Esophageal Sensitivity
• Pain

Intervention

Drug:
• AZD1386
oral, single dose
• Placebo
Oral solution, single dose

Locations

Country	Name	City	State
Denmark	Research Site	Arhus
Sweden	Research Site	Goteborg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS scale and clock		Several occasions during the study days	No
Secondary	VAS scale and pressure, VAS scale and current, VAS scale and acid volume		Several occasions during the study days	No
Secondary	Pharmacokinetic variables		Several occasions during the study days	No
Secondary	Safety variables (adverse events, blood pressure, safety lab, ECG and body temperature)		Several occasions during the study days	Yes