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Completed

NCT Number: NCT00711048

Esophageal Hypersensitivity Study in Healthy Volunteers

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

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Key information

Conditions

Pain Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Esophageal Sensitivity Gastroesophageal Reflux Gastrointestinal Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1386

Drug

oral, single dose

Placebo

Drug

Oral solution, single dose

Primary outcomes

  1. VAS scale and clock

    Time frame: Several occasions during the study days

Secondary outcomes

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

    Time frame: Several occasions during the study days

  2. Pharmacokinetic variables

    Time frame: Several occasions during the study days

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

    Time frame: Several occasions during the study days

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Study completion
2009
First posted
Jul 8, 2008
Registry last updated
Aug 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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