Investigate the effect of different doses of lesogaberan (AZD3355) as add-on to PPI in GERD patients with partial response to PPI

Study identifier:D9120C00019

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Medical condition

Gastroesophageal Reflux Disease, Acid Reflux

Phase

Phase 2

Healthy volunteers

Study drug

lesogaberan (AZD3355), Placebo

Sex

All

Actual Enrollment

661

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 01 Oct 2009

Primary Completion Date: 01 Jul 2010

Study Completion Date: 01 Jul 2010

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2011 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Oklahoma City, OK, United States

Arms	Assigned Interventions
Experimental: 60 mg PPI+lesogaberan (AZD3355) 60 mg bid	Drug: lesogaberan (AZD3355) 60 mg, oral, capsules, bid for 4 w
Experimental: 120 mg PPI+lesogaberan (AZD3355) 120 mg bid	Drug: lesogaberan (AZD3355) 120 mg, oral, capsules, bid for 4 w
Experimental: 180 mg PPI+lesogaberan (AZD3355) 180 mg bid	Drug: lesogaberan (AZD3355) 180 mg, oral, capsules, bid for 4 w
Experimental: 240 mg PPI+lesogaberan (AZD3355) 240 mg bid	Drug: lesogaberan (AZD3355) 240 mg, oral, capsules, bid for 4 w
Placebo Comparator: Placebo PPI+ Placebo	Drug: Placebo oral,capsules, bid for 4 w

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=428&filename=CSP-D9120C00019.pdf
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CSR-D9120C00019.pdf
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CSP-D9120C00019.pdf
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Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Debra Silberg

AstraZeneca