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Esophageal Hypersensitivity Study in Healthy Volunteers

Primary Purpose

Pain, Esophageal Sensitivity

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

AZD1386

Placebo

About this trial

This is an interventional basic science trial for Pain focused on measuring GERD, healthy volunteer, esophagus, pain

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts 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

Sites / Locations

Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

30 mg, oral, single dose

95 mg, oral, single dose

Oral solution, single dose

Outcomes

Primary Outcome Measures

VAS scale and clock

Secondary Outcome Measures

VAS scale and pressure, VAS scale and current, VAS scale and acid volume

Pharmacokinetic variables

Safety variables (adverse events, blood pressure, safety lab, ECG and body temperature)

Full Information

NCT ID

NCT00711048

First Posted

July 7, 2008

Last Updated

August 27, 2009

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00711048

Brief Title

Esophageal Hypersensitivity Study in Healthy Volunteers

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Esophageal Sensitivity

Keywords

GERD, healthy volunteer, esophagus, pain

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

30 mg, oral, single dose

Arm Title

Arm Type

Experimental

Arm Description

95 mg, oral, single dose

Arm Title

Arm Type

Placebo Comparator

Arm Description

Oral solution, single dose

Intervention Type

Drug

Intervention Name(s)

AZD1386

Intervention Description

oral, single dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral solution, single dose

Primary Outcome Measure Information:

Title

VAS scale and clock

Time Frame

Several occasions during the study days

Secondary Outcome Measure Information:

Title

VAS scale and pressure, VAS scale and current, VAS scale and acid volume

Time Frame

Several occasions during the study days

Title

Pharmacokinetic variables

Time Frame

Several occasions during the study days

Title

Safety variables (adverse events, blood pressure, safety lab, ECG and body temperature)

Time Frame

Several occasions during the study days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie Sundin

Organizational Affiliation

AstraZeneca R&D, Mölndal, Sweden

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Peter Funch-Jensen, MD, PhD

Organizational Affiliation

Aarhus University Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Arhus

Country

Denmark

Facility Name

Research Site

City

Goteborg

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

21410733

Citation

Krarup AL, Ny L, Astrand M, Bajor A, Hvid-Jensen F, Hansen MB, Simren M, Funch-Jensen P, Drewes AM. Randomised clinical trial: the efficacy of a transient receptor potential vanilloid 1 antagonist AZD1386 in human oesophageal pain. Aliment Pharmacol Ther. 2011 May;33(10):1113-22. doi: 10.1111/j.1365-2036.2011.04629.x. Epub 2011 Mar 16.

Results Reference

derived

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Esophageal Hypersensitivity Study in Healthy Volunteers

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