Esophageal Hypersensitivity Study in Healthy Volunteers - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00711048

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 I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Allergy Esophagus Disorders

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 ]

Arms	Assigned Interventions
1: Experimental 30 mg, oral, single dose	Drug: AZD1386 oral, single dose
2: Experimental 95 mg, oral, single dose	Drug: AZD1386 oral, single dose
3: Placebo Comparator Oral solution, single dose	Drug: Placebo Oral solution, single dose

Eligibility

Criteria

Inclusion Criteria:

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

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

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

Keywords provided by AstraZeneca:

GERD
healthy volunteer
esophagus
pain

Study placed in the following topic categories:

Hypersensitivity
Digestive System Diseases
Esophageal Disorder
Gastrointestinal Diseases

Pain
Healthy
Esophageal Diseases

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases
Esophageal Diseases

ClinicalTrials.gov processed this record on September 11, 2009