Esophageal Hypersensitivity Study in Healthy Volunteers

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: July 7, 2008
Last updated: August 27, 2009
Last verified: August 2009

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

Condition Intervention Phase
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:

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


Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00711048

Research Site
Arhus, Denmark
Research Site
Goteborg, Sweden
Sponsors and Collaborators
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 Identifier (NCT Number):
Responsible Party: Mark Berner Hansen, MD, PhD, Acting Medical Science Director, Emerging Products CV/GI, AstraZeneca Pharmaceuticals 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:
healthy volunteer

Additional relevant MeSH terms:
Immune System Diseases processed this record on April 15, 2014