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Esophageal Hypersensitivity Study in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00711048
First received: July 7, 2008
Last updated: August 27, 2009
Last verified: August 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Pain
Esophageal Sensitivity
 Drug: AZD1386
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • VAS scale and clock [ Time Frame: Several occasions during the study days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VAS scale and pressure, VAS scale and current, VAS scale and acid volume [ Time Frame: Several occasions during the study days ] [ Designated as safety issue: No ]
  • Pharmacokinetic variables [ Time Frame: Several occasions during the study days ] [ Designated as safety issue: No ]
  • Safety variables (adverse events, blood pressure, safety lab, ECG and body temperature) [ Time Frame: Several occasions during the study days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: June 2008
Study Completion Date: July 2009
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711048

Locations
Denmark
Research Site
Arhus, Denmark
Sweden
Research Site
Goteborg, Sweden
Sponsors and Collaborators
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
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mark Berner Hansen, MD, PhD, Acting Medical Science Director, Emerging Products CV/GI, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00711048     History of Changes
Other Study ID Numbers: D9127C00001, 2008-000313-30
Study First Received: July 7, 2008
Last Updated: August 27, 2009
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
GERD
healthy volunteer
esophagus
pain

Additional relevant MeSH terms:
Esophageal Diseases
Hypersensitivity
Gastrointestinal Diseases
Digestive System Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013