Esophageal Hypersensitivity Study in Healthy Volunteers

August 27, 2009 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Arhus, Denmark
        • Research Site
  • Sweden
      • Goteborg, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
30 mg, oral, single dose
Drug: AZD1386
oral, single dose
Experimental: 2
95 mg, oral, single dose
Drug: AZD1386
oral, single dose
Placebo Comparator: 3
Oral solution, single dose
Drug: Placebo
Oral solution, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VAS scale and clock
Time Frame: Several occasions during the study days
Several occasions during the study days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Marie Sundin, AstraZeneca R&D, Mölndal, Sweden
  • Principal Investigator: Peter Funch-Jensen, MD, PhD, Aarhus University Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

July 7, 2008

First Submitted That Met QC Criteria

July 7, 2008

First Posted (Estimate)

July 8, 2008

Study Record Updates

Last Update Posted (Estimate)

August 28, 2009

Last Update Submitted That Met QC Criteria

August 27, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9127C00001
  • 2008-000313-30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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