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Esophageal Hypersensitivity Study in Healthy Volunteers

NCT ID: NCT00711048

Last Updated: 2009-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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Conditions

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Pain Esophageal Sensitivity

Keywords

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GERD healthy volunteer esophagus pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

30 mg, oral, single dose

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

oral, single dose

2

95 mg, oral, single dose

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

oral, single dose

3

Oral solution, single dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral solution, single dose

Interventions

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AZD1386

oral, single dose

Intervention Type DRUG

Placebo

Oral solution, single dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Marie Sundin

Role: STUDY_DIRECTOR

AstraZeneca R&D, Mölndal, Sweden

Peter Funch-Jensen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Research Site

Aarhus, , Denmark

Site Status

Research Site

Gothenburg, , Sweden

Site Status

Countries

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Denmark Sweden

References

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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.

Reference Type DERIVED
PMID: 21410733 (View on PubMed)

Other Identifiers

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2008-000313-30

Identifier Type: -

Identifier Source: secondary_id

D9127C00001

Identifier Type: -

Identifier Source: org_study_id