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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , 1200 Belgium
Contact
1-800-718-1021
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.

NCT00730665
Pfizer
Terminated
Efficacy And Safety Of PF-00885706 For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD)

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Efficacy And Safety Of PF-00885706 For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD)
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gastroesophageal Reflux Disease
  • 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)
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
81
October 2008
October 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Brazil,   France,   Germany,   Korea, Republic of,   Slovakia,   Spain
United States
 
NCT00730665
A8311003
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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