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

NCT00730665

Last updated date
Study Location
Pfizer Investigational Site
Bruxelles, , 1200, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastroesophageal Reflux Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Gastroesophageal Reflux DiseaseEfficacy And Safety Of PF-00885706 For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD) NCT00730665
  1. Bruxelles,
  2. Salvador, BA
  3. Porto Alegre, RS
  4. Campinas, SP
  5. Sao Paulo, SP
  6. Nice, Cedex 3
  7. Bordeaux cedex,
  8. Laval,
  9. Lyon CEDEX 03,
  10. Marseille,
  11. Nantes CEDEX 1,
  12. Rennes,
  13. Segre,
  14. Tours cedex 9,
  15. Amberg,
  16. Berlin,
  17. Eisenach,
  18. Freising,
  19. Hamburg,
  20. Karlsruhe,
  21. Koenigslutter,
  22. Konstanz,
  23. Leipzig,
  24. Madgeburg,
  25. Mannheim,
  26. Muenchen,
  27. Muenster,
  28. Seoul,
  29. Seoul,
  30. Seoul,
  31. Seoul,
  32. Seoul,
  33. Bratislava,
  34. Bratislava,
  35. Bratislava,
  36. Trnava,
  37. Barcelona,
  38. Sevilla,
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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy And Safety Of PF-00885706 For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Reflux Disease
Intervention  ICMJE
  • Drug: PF-00885706
    Capsule, 100ug, every 12 hours (twice a day)
  • Drug: Esomeprazole
    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.
  • Drug: PF-00885706
    Capsule, 300ug, every 12 hours (twice a day)
  • Drug: PF-00885706
    Capsule, 1mg, every 12 hours (twice a day)
  • Drug: PF-00885706
    Capsule, 3mg, every 12 hours (twice a day)
  • Other: Placebo
    Capsule, Placebo, every 12 hours (twice a day)
Study Arms  ICMJE
  • Experimental: 100ug
    Interventions:
    • Drug: PF-00885706
    • Drug: Esomeprazole
  • Experimental: 300ug
    Interventions:
    • Drug: PF-00885706
    • Drug: Esomeprazole
  • Experimental: 1mg
    Interventions:
    • Drug: PF-00885706
    • Drug: Esomeprazole
  • Experimental: 3mg
    Interventions:
    • Drug: PF-00885706
    • Drug: Esomeprazole
  • Placebo Comparator: Placebo
    Interventions:
    • Other: Placebo
    • Drug: Esomeprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 12, 2009)
81
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2008)
450
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   France,   Germany,   Korea, Republic of,   Slovakia,   Spain
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00730665
Other Study ID Numbers  ICMJE A8311003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP