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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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
pain processed this record on November 25, 2014