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A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience

Primary Purpose

Gastroesophageal Reflux Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

AZD3355

placebo

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD, lesogaberan, impedance, pH, pharmacokinetics, safety, tolerability

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provide informed consent
History of GERD with persistent symptoms despite treatment with PPI
Otherwise normal physical health

Exclusion Criteria:

History of GERD with symptoms that has not improved at all during treatment with PPI
Prior surgery of the upper gastrointestinal tract
History of significant heart disease, cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric or gastrointestinal disorders besides GERD

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

AZD3355 30 mg

AZD3355 90 mg

AZD3355 120 mg

AZD3355 240 mg

Placebo

Outcomes

Primary Outcome Measures

Total Number of Reflux Episodes During 24 Hours

Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline)

Secondary Outcome Measures

Number of Acid Reflux Episodes

Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH <4 (or a drop of at least 1 pH unit if pH is already <4) lasting more than 5 s.

Number of Weakly Acidic Reflux Episodes

Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0-6.5 lasting more than 5 s.

Number of Weakly Alkaline Reflux Episodes

Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.

Full Information

NCT ID

NCT01043185

First Posted

December 22, 2009

Last Updated

May 13, 2011

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01043185

Brief Title

A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience

Official Title

A Double-blind, Placebo Controlled, Randomised, Phase IIA Pharmacodynamic 4-way Cross-over Study to Estimate the Dose Response Relationship of AZD3355 on the Number of Reflux Episodes Assessed by Impedance/pH in Patients With GERD and a Partial Response to PPI Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux Disease

Keywords

GERD, lesogaberan, impedance, pH, pharmacokinetics, safety, tolerability

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

AZD3355 30 mg

Arm Title

Arm Type

Experimental

Arm Description

AZD3355 90 mg

Arm Title

Arm Type

Experimental

Arm Description

AZD3355 120 mg

Arm Title

Arm Type

Experimental

Arm Description

AZD3355 240 mg

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

AZD3355

Intervention Description

30 mg orally in the morning and 30 mg in the evening for 1 day

Intervention Type

Drug

Intervention Name(s)

AZD3355

Intervention Description

90 mg orally in the morning and 90 mg in the evening for 1 day

Intervention Type

Drug

Intervention Name(s)

AZD3355

Intervention Description

120 mg orally in the morning and 120 mg in the evening for 1 day

Intervention Type

Drug

Intervention Name(s)

AZD3355

Intervention Description

240 mg orally in the morning and 240 mg in the evening for 1 day

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo capsules orally in the morning and placebo capsules in the evening for 1 day

Primary Outcome Measure Information:

Title

Total Number of Reflux Episodes During 24 Hours

Description

Time Frame

Measured during 24 hours at 4 different visits with a 7-28 days interval between

Secondary Outcome Measure Information:

Title

Number of Acid Reflux Episodes

Description

Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH <4 (or a drop of at least 1 pH unit if pH is already <4) lasting more than 5 s.

Time Frame

Measured during 24 hours at 4 different visits with a 7-28 days interval between

Title

Number of Weakly Acidic Reflux Episodes

Description

Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0-6.5 lasting more than 5 s.

Time Frame

Measured during 24 hours at 4 different visits with a 7-28 days interval between

Title

Number of Weakly Alkaline Reflux Episodes

Description

Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.

Time Frame

Measured during 24 hours at 4 different visits with a 7-28 days interval between

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provide informed consent History of GERD with persistent symptoms despite treatment with PPI Otherwise normal physical health Exclusion Criteria: History of GERD with symptoms that has not improved at all during treatment with PPI Prior surgery of the upper gastrointestinal tract History of significant heart disease, cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric or gastrointestinal disorders besides GERD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip Miner

Organizational Affiliation

Oklahoma Foundation of Digestive Research

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Debra G Silberg

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25407279

Citation

Miner PB Jr, Silberg DG, Ruth M, Miller F, Pandolfino J. Dose-dependent effects of lesogaberan on reflux measures in patients with refractory gastroesophageal reflux disease: a randomized, placebo-controlled study. BMC Gastroenterol. 2014 Nov 18;14:188. doi: 10.1186/1471-230X-14-188.

Results Reference

derived

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A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience

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