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This study has been placed on clinical hold by the sponsor due to operational reasons.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100ug | Experimental |
| |
| 300ug | Experimental |
| |
| 1mg | Experimental |
| |
| 3mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-00885706 | Drug | Capsule, 100ug, every 12 hours (twice a day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion 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:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Brussels | 1200 | Belgium | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 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. |
|
| PF-00885706 | Drug | Capsule, 300ug, every 12 hours (twice a day) |
|
| 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. |
|
| PF-00885706 | Drug | Capsule, 1mg, every 12 hours (twice a day) |
|
| 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. |
|
| PF-00885706 | Drug | Capsule, 3mg, every 12 hours (twice a day) |
|
| 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. |
|
| Placebo | Other | Capsule, Placebo, every 12 hours (twice a day) |
|
| 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. |
|
| 28 days |
| Composite score of heartburn and regurgitation frequency and severity | 28 days |
| Time to resolution of symptoms of heartburn/regurgitation | 28 days |
| Number of antacid rescue medication (Gaviscon) tablets used | 28 days |
| Severity of additional GERD symptoms | 28 days |
| Quality of Life (assessed using PAGI-QOL to PGIC (Patient Global Impression of Change) | 28 days |
| Complete resolution of heartburn | 28 days |
| Complete resolution of regurgitation | 28 days |
| Average severity of heartburn (daytime and night-time) | 28 days |
| Average severity of regurgitation (daytime and night-time) | 28 days |
| Salvador |
| Estado de Bahia |
| 40420-000 |
| Brazil |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Pfizer Investigational Site | Campinas | São Paulo | 13070-040 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 01244-030 | Brazil |
| Pfizer Investigational Site | Nice | Cedex 3 | 06002 | France |
| Pfizer Investigational Site | Bordeaux | 33075 | France |
| Pfizer Investigational Site | Laval | 53000 | France |
| Pfizer Investigational Site | Lyon | 69003 | France |
| Pfizer Investigational Site | Marseille | 13000 | France |
| Pfizer Investigational Site | Nantes | 44093 | France |
| Pfizer Investigational Site | Rennes | 35000 | France |
| Pfizer Investigational Site | Segré | 49500 | France |
| Pfizer Investigational Site | Tours | 37044 | France |
| Pfizer Investigational Site | Amberg | 92224 | Germany |
| Pfizer Investigational Site | Berlin | 10117 | Germany |
| Pfizer Investigational Site | Eisenach | 99817 | Germany |
| Pfizer Investigational Site | Freising | 85356 | Germany |
| Pfizer Investigational Site | Hamburg | 22143 | Germany |
| Pfizer Investigational Site | Karlsruhe | 76199 | Germany |
| Pfizer Investigational Site | Koenigslutter | 38154 | Germany |
| Pfizer Investigational Site | Konstanz | 78464 | Germany |
| Pfizer Investigational Site | Leipzig | 04109 | Germany |
| Pfizer Investigational Site | Madgeburg | 39120 | Germany |
| Pfizer Investigational Site | Mannheim | 68161 | Germany |
| Pfizer Investigational Site | München | 80469 | Germany |
| Pfizer Investigational Site | Münster | 48159 | Germany |
| Pfizer Investigational Site | Bratislava | 826 06 | Slovakia |
| Pfizer Investigational Site | Bratislava | 833 05 | Slovakia |
| Pfizer Investigational Site | Bratislava | 851 05 | Slovakia |
| Pfizer Investigational Site | Trnava | 917 02 | Slovakia |
| Pfizer Investigational Site | Seoul | 133-792 | South Korea |
| Pfizer Investigational Site | Seoul | 135-710 | South Korea |
| Pfizer Investigational Site | Seoul | 135-720 | South Korea |
| Pfizer Investigational Site | Seoul | 137-701 | South Korea |
| Pfizer Investigational Site | Seoul | 152-703 | South Korea |
| Pfizer Investigational Site | Barcelona | Barcelona | 08022 | Spain |
| Pfizer Investigational Site | Seville | Sevilla | 41014 | Spain |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C545705 | 1-((4-((((3-isopropyl-2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)carbonyl)amino)methyl)piperidin-1-yl)methyl)cyclobutanecarboxylic acid |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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