NCT00688402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

Enrollment Period

2 months

First QC Date

May 30, 2008

Last Update Submit

December 2, 2010

Conditions

Gastroesophageal Reflux Disease

Keywords

Reflux InhibitorGERDformulations

Outcome Measures

Primary Outcomes (1)

  • Specific AE questions

    During 0-4 hours post dose

Secondary Outcomes (2)

  • PK variables

    Frequent sampling up to 36 hours post dose

  • Safety variables (other adverse events, blood pressure, pulse, safety lab)

    During the whole treatment period

Study Arms (5)

1

EXPERIMENTAL

IR Formulation 65 mg

Drug: AZD3355

2

EXPERIMENTAL

IR Formulation 150 mg

Drug: AZD3355

3

EXPERIMENTAL

MR formulation, 1h 65 mg

Drug: AZD3355

4

EXPERIMENTAL

MR Formulation, 1h 150 mg

Drug: AZD3355

5

EXPERIMENTAL

MR Formulation, 2h 150 mg

Drug: AZD3355

Interventions

AZD3355DRUG

Single dose

Also known as: Lesogaberan
12345

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

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

Study Sites (1)

Research Site

Varvsgatan, Lulea, Sweden

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

lesogaberan

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Eva Ersdal, PhD

    AstraZeneca R&D, Mölndal, Sweden

    STUDY DIRECTOR

  • Aslak Rautio, MD

    Quintiles Hermelinen, Varvsgatan 53, SE-972 33 Luleå, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 3, 2008

Study Start

April 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

December 3, 2010

Record last verified: 2010-12

Locations

SE(1)