Gastroesophageal RefluxPhase 4NCT00246909
Determination of the Minimal Clinically Important Difference After Treatment With Pantoprazole in Patients With Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-340)
A Phase 4 study testing Pantoprazole in people with Gastroesophageal Reflux, run by Takeda at 51 sites in United States.
Trial summary
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Pantoprazole
- How many people
- 600 participants
- Where
- 51 sitesUnited States
- Study dates
- Nov 2005to Nov 2006
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main inclusion criteria:
- In general good health other than gastroesophageal reflux disease (GERD)
- History of GERD-related symptoms for at least 6 months prior to inclusion into the study
- Endoscopically confirmed gastroesophageal reflux disease
Main exclusion criteria:
- Acute peptic ulcer and/or ulcer complications
- Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors on more than 3 consecutive days within the previous 28 days; except regular intake of acetylsalicylic acid in dosages up to 163 mg/day
- Intake of Proton Pump Inhibitors and Histamine 2-receptor antagonists within the previous 14 days
- Intake of psychotropic medication, dyspepsia-inducing drugs, and anticholinergic agents
- Pregnant or nursing female patients; Non-pregnant, non-lactating female patients of childbearing potential who are not using reliable method of contraception
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Altana Pharma/Nycomed
Alabaster, Alabama, 35007
Altana Pharma/Nycomed
Anaheim, California, 92801
Altana Pharma/Nycomed
Baton Rouge, Louisiana, 70809
Altana Pharma/Nycomed
Bellevue, Washington, 98004
Altana Pharma/Nycomed
Bethesda, Maryland, 20814
Altana Pharma/Nycomed
Charleston, South Carolina, 29403
Altana Pharma/Nycomed
Chattanooga, Tennessee, 37404
Altana Pharma/Nycomed
Cincinnati, Ohio, 45219
Altana Pharma/Nycomed
Duncansville, Pennsylvania, 16635
Altana Pharma/Nycomed
Egg Harbor, New Jersey, 08234
Altana Pharma/Nycomed
Fairfax, Virginia, 22031
Altana Pharma/Nycomed
Great Neck, New York, 11021
Altana Pharma/Nycomed
Great Neck, New York, 11023
Altana Pharma/Nycomed
Hines, Illinois, 60141
Altana Pharma/Nycomed
Hollywood, Maryland, 20636
Altana Pharma/Nycomed
Houston, Texas, 77024
Altana Pharma/Nycomed
Houston, Texas, 77074
Altana Pharma/Nycomed
Houston, Texas, 77090
Altana Pharma/Nycomed
Huntsville, Alabama, 35801
Altana Pharma/Nycomed
Jackson, Mississippi, 39202
Altana Pharma/Nycomed
Johnson City, New York, 13790
Altana Pharma/Nycomed
Laurel, Maryland, 20707
Altana Pharma/Nycomed
Little Rock, Arkansas, 72117
Altana Pharma/Nycomed
Los Angeles, California, 90073
Altana Pharma/Nycomed
Louisville, Kentucky, 40202
Altana Pharma/Nycomed
Medford, Oregon, 97504
Altana Pharma/Nycomed
Mesa, Arizona, 85213
Altana Pharma/Nycomed
Miami, Florida, 33173
Altana Pharma/Nycomed
Milford, Massachusetts, 01757
Altana Pharma/Nycomed
Milwaukee, Wisconsin, 53233
Altana Pharma/Nycomed
Nashville, Tennessee, 37205
Altana Pharma/Nycomed
Orange, California, 92868
Altana Pharma/Nycomed
Orange, California, 92869
Altana Pharma/Nycomed
Pembroke Pines, Florida, 33024
Altana Pharma/Nycomed
Peoria, Illinois, 61602
Altana Pharma/Nycomed
Philadelphia, Pennsylvania, 19147
Altana Pharma/Nycomed
Pittsburgh, Pennsylvania, 15218
Altana Pharma/Nycomed
Raleigh, North Carolina, 27612
Altana Pharma/Nycomed
Redwood City, California, 94062
Altana Pharma/Nycomed
Reisterstown, Maryland, 20010
Altana Pharma/Nycomed
Rochester, New York, 14609
Altana Pharma/Nycomed
Salt Lake Citey, Utah, 84107
Altana Pharma/Nycomed
San Diego, California, 92103
Altana Pharma/Nycomed
San Diego, California, 92123
Altana Pharma/Nycomed
Shreveport, Louisiana, 71103
Altana Pharma/Nycomed
South Ogden, Utah, 84405
Altana Pharma/Nycomed
Torrington, Connecticut, 06790
Altana Pharma/Nycomed
Towson, Maryland, 21204
Altana Pharma/Nycomed
Tucson, Arizona, 85723
Altana Pharma/Nycomed
Wheat Ridge, Colorado, 80033
Altana Pharma/Nycomed
Winston-Salem, North Carolina, 27103
About this study
Official title: Determination of the Minimal Clinically Important Difference (MCID) of the Patient Orientated Self Assessment Scale ReQuest TradeMark in Patients Suffering From Endoscopically Confirmed Gastroesophageal Reflux Disease (GERD), Grade A-D According to Los Angeles Classification Treated With Pantoprazole 40 mg o.d. or Placebo o.d. Over One Week.
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms daily. Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD in a large proportion of patients.
Of particular interest in GERD is the assessment of symptom severity and quality of life, and the response of these parameters to treatment. Therefore, a questionnaire to assess GERD symptoms was developed (ReQuest TradeMark). An important point to consider when using such a questionnaire is to evaluate whether an observed difference in scores after a certain treatment represents a clinical effect.
The aim of this study is to determine the minimal clinically important difference (MCID) in patients diagnosed with GERD. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest TradeMark). Endoscopy will be performed at the start of the study. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (8 weeks). During the first treatment week, the patients will receive either pantoprazole (tablet) or placebo once daily in the morning; for the following 7 treatment weeks all patients will receive pantoprazole. The study will provide further data on safety and tolerability of pantoprazole.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Pantoprazole
- Keywords
- Gastroesophageal Reflux, Gastroesophageal Reflux Disease, Pantoprazole
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
ReQuest(tm) scores after one week of treatment.
Secondary outcomes (2)
other symptom assessments
safety.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by TakedaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hartmut Heinze, PhD, Study chair, Altana Pharma, D-78467 Konstanz, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246909
- Sponsor's protocol ID
- BY1023/M3-340
- Status last verified
- Jun 2011
- First submitted
- 31 Oct 2005
- Last updated
- 7 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Minimal Clinically Important Difference (MCID) of the Patient Orientated Self Assessment Scale ReQuest TradeMark in Patients Suffering From Endoscopically Confirmed Gastroesophageal Reflux Disease (GERD), Grade A-D According to Los Angeles Classification Treated With Pantoprazole 40 mg o.d. or Placebo o.d. Over One Week.
- ClinicalTrials.gov ID
- NCT00246909
- Acronym / sponsor ID
- BY1023/M3-340
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastroesophageal Reflux, Gastroesophageal Reflux Disease, Pantoprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 1 Nov 2005 (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.
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms daily. Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD in a large proportion of patients.
Of particular interest in GERD is the assessment of symptom severity and quality of life, and the response of these parameters to treatment. Therefore, a questionnaire to assess GERD symptoms was developed (ReQuest TradeMark). An important point to consider when using such a questionnaire is to evaluate whether an observed difference in scores after a certain treatment represents a clinical effect.
The aim of this study is to determine the minimal clinically important difference (MCID) in patients diagnosed with GERD. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest TradeMark). Endoscopy will be performed at the start of the study. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (8 weeks). During the first treatment week, the patients will receive either pantoprazole (tablet) or placebo once daily in the morning; for the following 7 treatment weeks all patients will receive pantoprazole. The study will provide further data on safety and tolerability of pantoprazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Pantoprazole | Drug | – |
Primary outcome
ReQuest(tm) scores after one week of treatment.
2 secondary outcomes
other symptom assessments
safety.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
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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.
Hartmut Heinze, PhD study chair
Altana Pharma, D-78467 Konstanz, Germany
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pantoprazole in people with Gastroesophageal Reflux, run by Takeda at 51 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ReQuest(tm) scores after one week of treatment.. 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 7 May 2012.