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

NCT00730665 | Terminated Phase 2 DMC

• 1 other identifier: A8311003
• Study Type: interventional
• Target: 81
• Locations: 7 countries
• Sites: 38

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

PPI partial responders with non-erosive GERD.

Outcome Measures

Primary Outcomes (1)

• 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)]

  28 days

Secondary Outcomes (12)

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

  28 days

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

  28 days

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

  28 days

• Composite score of heartburn and regurgitation frequency and severity

  28 days

• Time to resolution of symptoms of heartburn/regurgitation

  28 days

Study Arms (5)

100ug

EXPERIMENTAL

Drug: PF-00885706; Drug: Esomeprazole

300ug

EXPERIMENTAL

Drug: PF-00885706; Drug: Esomeprazole

1mg

EXPERIMENTAL

Drug: PF-00885706; Drug: Esomeprazole

3mg

EXPERIMENTAL

Drug: PF-00885706; Drug: Esomeprazole

Placebo

PLACEBO COMPARATOR

Other: Placebo; Drug: Esomeprazole

Interventions

PF-00885706 DRUG

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

100ug

Esomeprazole DRUG

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.

100ug

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (38)

Pfizer Investigational Site

Brussels, 1200, Belgium

Location

Pfizer Investigational Site

Salvador, Estado de Bahia, 40420-000, Brazil

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Pfizer Investigational Site

Campinas, São Paulo, 13070-040, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 01244-030, Brazil

Location

Pfizer Investigational Site

Nice, Cedex 3, 06002, France

Location

Pfizer Investigational Site

Bordeaux, 33075, France

Location

Pfizer Investigational Site

Laval, 53000, France

Location

Pfizer Investigational Site

Lyon, 69003, France

Location

Pfizer Investigational Site

Marseille, 13000, France

Location

Pfizer Investigational Site

Nantes, 44093, France

Location

Pfizer Investigational Site

Rennes, 35000, France

Location

Pfizer Investigational Site

Segré, 49500, France

Location

Pfizer Investigational Site

Tours, 37044, France

Location

Pfizer Investigational Site

Amberg, 92224, Germany

Location

Pfizer Investigational Site

Berlin, 10117, Germany

Location

Pfizer Investigational Site

Eisenach, 99817, Germany

Location

Pfizer Investigational Site

Freising, 85356, Germany

Location

Pfizer Investigational Site

Hamburg, 22143, Germany

Location

Pfizer Investigational Site

Karlsruhe, 76199, Germany

Location

Pfizer Investigational Site

Koenigslutter, 38154, Germany

Location

Pfizer Investigational Site

Konstanz, 78464, Germany

Location

Pfizer Investigational Site

Leipzig, 04109, Germany

Location

Pfizer Investigational Site

Madgeburg, 39120, Germany

Location

Pfizer Investigational Site

Mannheim, 68161, Germany

Location

Pfizer Investigational Site

München, 80469, Germany

Location

Pfizer Investigational Site

Münster, 48159, Germany

Location

Pfizer Investigational Site

Bratislava, 826 06, Slovakia

Location

Pfizer Investigational Site

Bratislava, 833 05, Slovakia

Location

Pfizer Investigational Site

Bratislava, 851 05, Slovakia

Location

Pfizer Investigational Site

Trnava, 917 02, Slovakia

Location

Pfizer Investigational Site

Seoul, 133-792, South Korea

Location

Pfizer Investigational Site

Seoul, 135-710, South Korea

Location

Pfizer Investigational Site

Seoul, 135-720, South Korea

Location

Pfizer Investigational Site

Seoul, 137-701, South Korea

Location

Pfizer Investigational Site

Seoul, 152-703, South Korea

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08022, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, 41014, Spain

Location

Related Links

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

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

1-((4-((((3-isopropyl-2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)carbonyl)amino)methyl)piperidin-1-yl)methyl)cyclobutanecarboxylic acid; Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 8, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: July 14, 2011

Record last verified: 2011-07

Locations

ES (2); FR (9); BR (4); DE (13); BE (1); SL (4); KR (5)