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Esophageal Hypersensitivity Study in Patients With Gastroesophageal Reflux Disease (GERD)

NCT ID: NCT01019928

Last Updated: 2012-11-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-01-31

Brief Summary

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

Detailed Description

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Conditions

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Sensitivity in Esophagus

Keywords

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GERD patient esophagus pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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First AZD1386, then washout, then placebo

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

95 mg, oral solution, single dose

Placebo to AZD1386

Intervention Type DRUG

Placebo, oral solution, single dose

First placebo, then washout, then AZD1386

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

95 mg, oral solution, single dose

Placebo to AZD1386

Intervention Type DRUG

Placebo, oral solution, single dose

Interventions

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AZD1386

95 mg, oral solution, single dose

Intervention Type DRUG

Placebo to AZD1386

Placebo, oral solution, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed informed consent form
* BMI 18.5-35.0, inclusive
* Continuous PPI treatment for GERD during the last 4 weeks

Exclusion Criteria

* Patients that have not experienced any GERD symptoms improvement at all after PPI treatment
* Unstable or clinically significant disorders including cardiovascular, respiratory, renal, hepatic, metabolic, psychiatric, other gastrointestinal and esophageal disorders besides GERD
* Prior surgery of the upper GI tract
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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 Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark

Locations

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Research Site

Århus C, , Denmark

Site Status

Research Site

Gothenburg, Västra Götaland County, Sweden

Site Status

Countries

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Denmark Sweden

References

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Krarup AL, Ny L, Gunnarsson J, Hvid-Jensen F, Zetterstrand S, Simren M, Funch-Jensen P, Hansen MB, Drewes AM. Randomized clinical trial: inhibition of the TRPV1 system in patients with nonerosive gastroesophageal reflux disease and a partial response to PPI treatment is not associated with analgesia to esophageal experimental pain. Scand J Gastroenterol. 2013 Mar;48(3):274-84. doi: 10.3109/00365521.2012.758769. Epub 2013 Jan 16.

Reference Type DERIVED
PMID: 23320520 (View on PubMed)

Other Identifiers

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2008-007420-26

Identifier Type: -

Identifier Source: secondary_id

D9127C00002

Identifier Type: -

Identifier Source: org_study_id