Efficacy And Safety Of PF-00885706 For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD)

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

PF-00885706

Esomeprazole

PF-00885706

Esomeprazole

PF-00885706

Esomeprazole

PF-00885706

Esomeprazole

Placebo

Esomeprazole

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring PPI partial responders with non-erosive GERD.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects with a diagnosis of GERD who fulfill the following criteria:

who have symptoms for least six months prior to enrollment; who are currently on daily treatment with a PPI and have been on such treatment for at least 3 months; whose symptoms are persistent, troublesome and that include heartburn and/or regurgitation as their predominant symptoms despite treatment with a PPI; who are seeking relief of persistent symptoms.

Exclusion Criteria:

Subjects with erosive esophagitis - An endoscopy within the last 5 years is required to verify absence.
Subjects with any esophageal or gastric diseases/conditions that may contribute to their GERD symptoms.
If female; pregnant, lactating or positive serum or urine pregnancy tests.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

100ug

300ug

1mg

3mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Complete resolution of heartburn and regurgitation. [i.e. no more than one day with either mild heartburn or regurgitation over the seven days prior to the assessment time-point (Visit 6 and Visit 8)]

Secondary Outcome Measures

Number of days with heartburn (daytime and night-time)

Number of days with regurgitation (daytime and night-time)

Number of heartburn and regurgitation-free days (24hrs)

Composite score of heartburn and regurgitation frequency and severity

Time to resolution of symptoms of heartburn/regurgitation

Number of antacid rescue medication (Gaviscon) tablets used

Severity of additional GERD symptoms

Quality of Life (assessed using PAGI-QOL to PGIC (Patient Global Impression of Change)

Complete resolution of heartburn

Complete resolution of regurgitation

Average severity of heartburn (daytime and night-time)

Average severity of regurgitation (daytime and night-time)

Full Information

NCT ID

NCT00730665

First Posted

August 6, 2008

Last Updated

July 12, 2011

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00730665

Brief Title

Efficacy And Safety Of PF-00885706 For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD)

Official Title

A Parallel-Group, Randomized, Double-Blind, Multi-Center Dose Response Study To Evaluate The Efficacy And Safety Of PF-00885706, A 5-HT4 Receptor Partial Agonist, As Add-On Therapy To Esomeprazole For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD) Who Have A Poor Response To Proton Pump Inhibitor (PPI) Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Terminated

Why Stopped

This study has been placed on clinical hold by the sponsor due to operational reasons.

Study Start Date

January 2008 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To understand the dose-response characteristics of PF-00885706 for efficacy in terms of symptomatic relief when used as add-on treatment to esomeprazole 20mg (standard proton pump inhibitor [PPI] treatment), in subjects with gastro-esophageal reflux (GERD) who have inadequate relief with PPIs.

6. Conditions and Keywords

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

Gastroesophageal Reflux Disease

Keywords

PPI partial responders with non-erosive GERD.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

100ug

Arm Type

Experimental

Arm Title

300ug

Arm Type

Experimental

Arm Title

1mg

Arm Type

Experimental

Arm Title

3mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

PF-00885706

Intervention Description

Capsule, 100ug, every 12 hours (twice a day)

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Intervention Description

Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.

Intervention Type

Drug

Intervention Name(s)

PF-00885706

Intervention Description

Capsule, 300ug, every 12 hours (twice a day)

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Intervention Description

Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.

Intervention Type

Drug

Intervention Name(s)

PF-00885706

Intervention Description

Capsule, 1mg, every 12 hours (twice a day)

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Intervention Description

Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.

Intervention Type

Drug

Intervention Name(s)

PF-00885706

Intervention Description

Capsule, 3mg, every 12 hours (twice a day)

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Intervention Description

Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Capsule, Placebo, every 12 hours (twice a day)

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Intervention Description

Patients entering the run-in phase lasting 6 weeks (42 days) will be switched from their current proton pump inhibitor (PPI) treatment and maintained on a standard background PPI - open label esomeprazole 20 mg to be taken once daily 1 hour before breakfast. Subjects meeting randomization criteria at Visit 4 are randomly assigned to one of the active arms of PF-00885706 or matching placebo, in addition to esomeprazole.

Primary Outcome Measure Information:

Title

Complete resolution of heartburn and regurgitation. [i.e. no more than one day with either mild heartburn or regurgitation over the seven days prior to the assessment time-point (Visit 6 and Visit 8)]

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Number of days with heartburn (daytime and night-time)

Time Frame

28 days

Title

Number of days with regurgitation (daytime and night-time)

Time Frame

28 days

Title

Number of heartburn and regurgitation-free days (24hrs)

Time Frame

28 days

Title

Composite score of heartburn and regurgitation frequency and severity

Time Frame

28 days

Title

Time to resolution of symptoms of heartburn/regurgitation

Time Frame

28 days

Title

Number of antacid rescue medication (Gaviscon) tablets used

Time Frame

28 days

Title

Severity of additional GERD symptoms

Time Frame

28 days

Title

Quality of Life (assessed using PAGI-QOL to PGIC (Patient Global Impression of Change)

Time Frame

28 days

Title

Complete resolution of heartburn

Time Frame

28 days

Title

Complete resolution of regurgitation

Time Frame

28 days

Title

Average severity of heartburn (daytime and night-time)

Time Frame

28 days

Title

Average severity of regurgitation (daytime and night-time)

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Subjects with a diagnosis of GERD who fulfill the following criteria: who have symptoms for least six months prior to enrollment; who are currently on daily treatment with a PPI and have been on such treatment for at least 3 months; whose symptoms are persistent, troublesome and that include heartburn and/or regurgitation as their predominant symptoms despite treatment with a PPI; who are seeking relief of persistent symptoms. Exclusion Criteria: Subjects with erosive esophagitis - An endoscopy within the last 5 years is required to verify absence. Subjects with any esophageal or gastric diseases/conditions that may contribute to their GERD symptoms. If female; pregnant, lactating or positive serum or urine pregnancy tests.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Salvador

State/Province

BA

ZIP/Postal Code

40420-000

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Porto Alegre

State/Province

RS

ZIP/Postal Code

90035-003

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Campinas

State/Province

SP

ZIP/Postal Code

13070-040

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Sao Paulo

State/Province

SP

ZIP/Postal Code

01244-030

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Nice

State/Province

Cedex 3

ZIP/Postal Code

06002

Country

France

Facility Name

Pfizer Investigational Site

City

Bordeaux cedex

ZIP/Postal Code

33075

Country

France

Facility Name

Pfizer Investigational Site

City

Laval

ZIP/Postal Code

53000

Country

France

Facility Name

Pfizer Investigational Site

City

Lyon CEDEX 03

ZIP/Postal Code

69003

Country

France

Facility Name

Pfizer Investigational Site

City

Marseille

ZIP/Postal Code

13000

Country

France

Facility Name

Pfizer Investigational Site

City

Nantes CEDEX 1

ZIP/Postal Code

44093

Country

France

Facility Name

Pfizer Investigational Site

City

Rennes

ZIP/Postal Code

35000

Country

France

Facility Name

Pfizer Investigational Site

City

Segre

ZIP/Postal Code

49500

Country

France

Facility Name

Pfizer Investigational Site

City

Tours cedex 9

ZIP/Postal Code

37044

Country

France

Facility Name

Pfizer Investigational Site

City

Amberg

ZIP/Postal Code

92224

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Pfizer Investigational Site

City

Eisenach

ZIP/Postal Code

99817

Country

Germany

Facility Name

Pfizer Investigational Site

City

Freising

ZIP/Postal Code

85356

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hamburg

ZIP/Postal Code

22143

Country

Germany

Facility Name

Pfizer Investigational Site

City

Karlsruhe

ZIP/Postal Code

76199

Country

Germany

Facility Name

Pfizer Investigational Site

City

Koenigslutter

ZIP/Postal Code

38154

Country

Germany

Facility Name

Pfizer Investigational Site

City

Konstanz

ZIP/Postal Code

78464

Country

Germany

Facility Name

Pfizer Investigational Site

City

Leipzig

ZIP/Postal Code

04109

Country

Germany

Facility Name

Pfizer Investigational Site

City

Madgeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Pfizer Investigational Site

City

Mannheim

ZIP/Postal Code

68161

Country

Germany

Facility Name

Pfizer Investigational Site

City

Muenchen

ZIP/Postal Code

80469

Country

Germany

Facility Name

Pfizer Investigational Site

City

Muenster

ZIP/Postal Code

48159

Country

Germany

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

133-792

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

135-720

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

152-703

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Bratislava

ZIP/Postal Code

826 06

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Bratislava

ZIP/Postal Code

833 05

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Bratislava

ZIP/Postal Code

851 05

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Trnava

ZIP/Postal Code

917 02

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Barcelona

ZIP/Postal Code

08022

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8311003&StudyName=Efficacy%20And%20Safety%20Of%20PF-00885706%20For%20The%20Relief%20Of%20Symptoms%20In%20Subjects%20With%20Gastro-esophageal%20Reflux%20Disease%20%28GERD%29

Description

To obtain contact information for a study center near you, click here.

Gastroesophageal Reflux Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial