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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

July 7, 2008
August 27, 2009
June 2008
Not Provided
VAS scale and clock [ Time Frame: Several occasions during the study days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00711048 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Esophageal Hypersensitivity Study in Healthy Volunteers
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

The purpose of the study is to compare sensitivity and sensitization of visceral pain in the esophagus using different pain stimuli
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Pain
  • Esophageal Sensitivity
  • Drug: AZD1386
    oral, single dose
  • Drug: Placebo
    Oral solution, single dose
  • Experimental: 1
    30 mg, oral, single dose
    Intervention: Drug: AZD1386
  • Experimental: 2
    95 mg, oral, single dose
    Intervention: Drug: AZD1386
  • Placebo Comparator: 3
    Oral solution, single dose
    Intervention: Drug: Placebo
Krarup AL, Ny L, Astrand M, Bajor A, Hvid-Jensen F, Hansen MB, Simrén M, Funch-Jensen P, Drewes AM. Randomised clinical trial: the efficacy of a transient receptor potential vanilloid 1 antagonist AZD1386 in human oesophageal pain. Aliment Pharmacol Ther. 2011 May;33(10):1113-22. Epub 2011 Mar 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
July 2009
Not Provided

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
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark,   Sweden
 
NCT00711048
D9127C00001, 2008-000313-30
No
Mark Berner Hansen, MD, PhD, Acting Medical Science Director, Emerging Products CV/GI, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
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
AstraZeneca
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP