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Study to Compare Different Formulations of AZD3355

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ClinicalTrials.gov Identifier: NCT00688402
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : December 3, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The purpose of the study is to compare different formulations of AZD3355 in regard to possible adverse events such as sensations of numbness, tinglings and heat in the skin.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: AZD3355 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Double-blind, Randomized, Cross-over Design, Phase 1 Pharmacodynamic Study to Investigate the Effect of Different Formulations of AZD3355 for the Development of Paresthesiae After Dosing in Healthy Subjects
Study Start Date : April 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
IR Formulation 65 mg
Drug: AZD3355
Single dose
Other Name: Lesogaberan
Experimental: 2
IR Formulation 150 mg
Drug: AZD3355
Single dose
Other Name: Lesogaberan
Experimental: 3
MR formulation, 1h 65 mg
Drug: AZD3355
Single dose
Other Name: Lesogaberan
Experimental: 4
MR Formulation, 1h 150 mg
Drug: AZD3355
Single dose
Other Name: Lesogaberan
Experimental: 5
MR Formulation, 2h 150 mg
Drug: AZD3355
Single dose
Other Name: Lesogaberan



Primary Outcome Measures :
  1. Specific AE questions [ Time Frame: During 0-4 hours post dose ]

Secondary Outcome Measures :
  1. PK variables [ Time Frame: Frequent sampling up to 36 hours post dose ]
  2. Safety variables (other adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of written informed consent
  • Female subjects with no childbearing potentials or using highly efficient contraceptive methods
  • Clinically normal physical findings

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688402


Locations
Sweden
Research Site
Varvsgatan, Lulea, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Eva Ersdal, PhD AstraZeneca R&d, Mölndal, Sweden
Principal Investigator: Aslak Rautio, MD Quintiles Hermelinen, Varvsgatan 53, SE-972 33 Luleå, Sweden

Responsible Party: Debra G. Silberg, MD, PhD, Medical Science Director, AZD3355, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00688402     History of Changes
Other Study ID Numbers: D9120C00031
EudraCT nr 2007-007126-22
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Reflux Inhibitor
GERD
formulations

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lesogaberan
Gastrointestinal Agents
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs