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
2 other identifiers
interventional
45
2 countries
2
Brief Summary
The purpose of the study is to compare sensitivity and sensitization of visceral pain in the esophagus using different pain stimuli
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 pain
Started Jun 2008
Typical duration for phase_1 pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 7, 2008
CompletedFirst Posted
Study publicly available on registry
July 8, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedAugust 28, 2009
August 1, 2009
July 7, 2008
August 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VAS scale and clock
Several occasions during the study days
Secondary Outcomes (3)
VAS scale and pressure, VAS scale and current, VAS scale and acid volume
Several occasions during the study days
Pharmacokinetic variables
Several occasions during the study days
Safety variables (adverse events, blood pressure, safety lab, ECG and body temperature)
Several occasions during the study days
Study Arms (3)
1
EXPERIMENTAL30 mg, oral, single dose
2
EXPERIMENTAL95 mg, oral, single dose
3
PLACEBO COMPARATOROral solution, single dose
Interventions
Eligibility Criteria
You may qualify if:
- Provision of written consent
- Clinically normal physical findings
- Sensitization potential
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Research Site
Aarhus, Denmark
Research Site
Gothenburg, Sweden
Related Publications (1)
Krarup AL, Ny L, Astrand M, Bajor A, Hvid-Jensen F, Hansen MB, Simren 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. doi: 10.1111/j.1365-2036.2011.04629.x. Epub 2011 Mar 16.
PMID: 21410733DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 7, 2008
First Posted
July 8, 2008
Study Start
June 1, 2008
Study Completion
July 1, 2009
Last Updated
August 28, 2009
Record last verified: 2009-08