Gastroesophageal Reflux DiseasePhase 2NCT00730665
Efficacy And Safety Of PF-00885706 For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD)
A Phase 2 study testing PF-00885706 and Esomeprazole in people with Gastroesophageal Reflux Disease, run by Pfizer at 38 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- PF-00885706 and Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 38 sitesin 7 countries
- Study dates
- Jan 2008to Oct 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
38 sites in 7 countries.
38 sites in 7 countries
Germany13 sites
Pfizer Investigational Site
Amberg, 92224
Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Eisenach, 99817
Pfizer Investigational Site
Freising, 85356
Pfizer Investigational Site
Hamburg, 22143
Pfizer Investigational Site
Karlsruhe, 76199
Pfizer Investigational Site
Koenigslutter, 38154
Pfizer Investigational Site
Konstanz, 78464
Pfizer Investigational Site
Leipzig, 04109
Pfizer Investigational Site
Madgeburg, 39120
Pfizer Investigational Site
Mannheim, 68161
Pfizer Investigational Site
München, 80469
Pfizer Investigational Site
Münster, 48159
France9 sites
Pfizer Investigational Site
Bordeaux, 33075
Pfizer Investigational Site
Laval, 53000
Pfizer Investigational Site
Lyon, 69003
Pfizer Investigational Site
Marseille, 13000
Pfizer Investigational Site
Nantes, 44093
Pfizer Investigational Site
Nice, Cedex 3, 06002
Pfizer Investigational Site
Rennes, 35000
Pfizer Investigational Site
Segré, 49500
Pfizer Investigational Site
Tours, 37044
South Korea5 sites
Pfizer Investigational Site
Seoul, 133-792
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 135-720
Pfizer Investigational Site
Seoul, 137-701
Pfizer Investigational Site
Seoul, 152-703
Brazil4 sites
Pfizer Investigational Site
Campinas, São Paulo, 13070-040
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-003
Pfizer Investigational Site
Salvador, Estado de Bahia, 40420-000
Pfizer Investigational Site
São Paulo, São Paulo, 01244-030
Slovakia4 sites
Pfizer Investigational Site
Bratislava, 826 06
Pfizer Investigational Site
Bratislava, 833 05
Pfizer Investigational Site
Bratislava, 851 05
Pfizer Investigational Site
Trnava, 917 02
Spain2 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08022
Pfizer Investigational Site
Seville, Sevilla, 41014
About this study
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
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
- Being tested
- PF-00885706, Esomeprazole, Placebo
- Keywords
- PPI partial responders with non-erosive GERD.
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-00885706Drug
Capsule, 100ug, every 12 hours (twice a day)
EsomeprazoleDrug
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-00885706Drug
Capsule, 300ug, every 12 hours (twice a day)
EsomeprazoleDrug
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-00885706Drug
Capsule, 1mg, every 12 hours (twice a day)
EsomeprazoleDrug
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-00885706Drug
Capsule, 3mg, every 12 hours (twice a day)
EsomeprazoleDrug
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.
PlaceboOther
Capsule, Placebo, every 12 hours (twice a day)
EsomeprazoleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 100ug | Experimental | Not described Receives: Drug: PF-00885706; Drug: Esomeprazole |
| 300ug | Experimental | Not described Receives: Drug: PF-00885706; Drug: Esomeprazole |
| 1mg | Experimental | Not described Receives: Drug: PF-00885706; Drug: Esomeprazole |
| 3mg | Experimental | Not described Receives: Drug: PF-00885706; Drug: Esomeprazole |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo; Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)]
Measured: 28 days
Secondary outcomes (12)
Number of days with heartburn (daytime and night-time)
Measured: 28 days
Number of days with regurgitation (daytime and night-time)
Measured: 28 days
Number of heartburn and regurgitation-free days (24hrs)
Measured: 28 days
Composite score of heartburn and regurgitation frequency and severity
Measured: 28 days
Time to resolution of symptoms of heartburn/regurgitation
Measured: 28 days
Number of antacid rescue medication (Gaviscon) tablets used
Measured: 28 days
Severity of additional GERD symptoms
Measured: 28 days
Quality of Life (assessed using PAGI-QOL to PGIC (Patient Global Impression of Change)
Measured: 28 days
Complete resolution of heartburn
Measured: 28 days
Complete resolution of regurgitation
Measured: 28 days
Average severity of heartburn (daytime and night-time)
Measured: 28 days
Average severity of regurgitation (daytime and night-time)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: This study has been placed on clinical hold by the sponsor due to operational reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730665
- Sponsor's protocol ID
- A8311003
- Status last verified
- Jul 2011
- First submitted
- 6 Aug 2008
- Last updated
- 14 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00730665
- Acronym / sponsor ID
- A8311003
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- PPI partial responders with non-erosive GERD.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study has been placed on clinical hold by the sponsor due to operational reasons.
- Enrolment
- 81 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-00885706Capsule, 100ug, every 12 hours (twice a day) | Drug | 100ug |
| EsomeprazolePatients 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 | 100ug |
| PF-00885706Capsule, 300ug, every 12 hours (twice a day) | Drug | 300ug |
| EsomeprazolePatients 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 | 300ug |
| PF-00885706Capsule, 1mg, every 12 hours (twice a day) | Drug | 1mg |
| EsomeprazolePatients 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 | 1mg |
| PF-00885706Capsule, 3mg, every 12 hours (twice a day) | Drug | 3mg |
| EsomeprazolePatients 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 | 3mg |
| PlaceboCapsule, Placebo, every 12 hours (twice a day) | Other | Placebo |
| EsomeprazolePatients 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 | Placebo |
Primary outcome
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
12 secondary outcomes
Number of days with heartburn (daytime and night-time)
Time frame: 28 days
Number of days with regurgitation (daytime and night-time)
Time frame: 28 days
Number of heartburn and regurgitation-free days (24hrs)
Time frame: 28 days
Composite score of heartburn and regurgitation frequency and severity
Time frame: 28 days
Time to resolution of symptoms of heartburn/regurgitation
Time frame: 28 days
Number of antacid rescue medication (Gaviscon) tablets used
Time frame: 28 days
Severity of additional GERD symptoms
Time frame: 28 days
Quality of Life (assessed using PAGI-QOL to PGIC (Patient Global Impression of Change)
Time frame: 28 days
Complete resolution of heartburn
Time frame: 28 days
Complete resolution of regurgitation
Time frame: 28 days
Average severity of heartburn (daytime and night-time)
Time frame: 28 days
Average severity of regurgitation (daytime and night-time)
Time frame: 28 days
Results and safety
The study was stopped early (reason given: This study has been placed on clinical hold by the sponsor due to operational reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Gastroesophageal Reflux Disease
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
38 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-00885706 and Esomeprazole in people with Gastroesophageal Reflux Disease, run by Pfizer at 38 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Germany, France, South Korea, Brazil, Slovakia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study has been placed on clinical hold by the sponsor due to operational reasons.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2011.