Gastroesophageal Reflux DiseasePhase 4NCT00449813
The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms (BY1023/NL511)
A Phase 4 study testing Pantoprazole in people with Gastroesophageal Reflux Disease and Non-erosive Reflux Disease, run by Takeda at 15 sites in 2 countries.
Trial summary
The aim of the study is to compare two different endpoint measures: heartburn as assessed by the physicians versus gastroesophageal reflux disease (GERD)-related symptoms as assessed by the patient using the ReQuest™ questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease, Non-erosive Reflux Disease
- What is being tested?
- Pantoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Mar 2007to Nov 2008
- 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
Who may be able to join
- Written informed consent
- Outpatients of at least 18 years of age
- History of GERD-related symptoms of at least 6 months prior to baseline visit
- Endoscopically-confirmed GERD or non-erosive GERD
Who cannot join
- Zollinger-Ellison syndrome or other gastric hypersecretory condition
- Acute peptic ulcer and/or ulcer complications
- Pyloric stenosis
- Severe or unstable cardiovascular, pulmonary, and/or endocrine disease
- Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of reliable contraception in women of child-bearing potential
- Intake of any medication for the purpose of eradication of Helicobacter pylori (H. pylori) within the last 28 days prior to study start
- Intake of systemic glucocorticoids or non-steroidal anti-inflammatory drugs including cyclooxygenase-2 (COX-2) inhibitors for more than 3 consecutive days within the last 28 days prior to study start; with the exception of acetylsalicylic acid not more than 150 mg per day
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Switzerland12 sites
Altana Pharma/Nycomed
Basel, 4001
Altana Pharma/Nycomed
Basel, 4051
Altana Pharma/Nycomed
Biel/Bienne, 2502
Altana Pharma/Nycomed
Bülach, 8180
Altana Pharma/Nycomed
Locarno, TI., 6600
Altana Pharma/Nycomed
Lucerne, 6003
Altana Pharma/Nycomed
Lucerne, 6004
Altana Pharma/Nycomed
Reinach, 4153
Altana Pharma/Nycomed
Sion, 1950
Altana Pharma/Nycomed
Thun, 3600
Altana Pharma/Nycomed
Winterthur, 8400
Altana Pharma/Nycomed
Zurich, 8050
Netherlands3 sites
Altana Pharma/Nycomed
BT Oss, 5342
Altana Pharma/Nycomed
Den Helder, 1782 GZ
Altana Pharma/Nycomed
EH Geldrop, 5664
About this study
Official title: The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms
The aim of the study is to compare two different endpoint measures: heartburn as assessed by the physicians versus gastroesophageal reflux disease (GERD)-related symptoms as assessed by the patient using the ReQuest™ questionnaire. The assessment is made in GERD-patients treated with a daily dose of 40 mg oral pantoprazole over an 8-week period.
- Being tested
- Pantoprazole
- Keywords
- Gastroesophageal reflux disease (GERD), Non erosive reflux disease (NERD)
- Medical subject headings
- Gastroesophageal Reflux, Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
40 mg Pantoprazole
| Study group | Role | What they receive |
|---|---|---|
| 1. | Active comparator | 40 mg Pantoprazole Receives: Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of misclassification on day 14 based on heartburn as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-gastrointestinal (GI) questionnaire
Measured: 8 weeks
Secondary outcomes (1)
Rate of misclassification on day 14 based on acid regurgitation as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-GI questionnaire
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2007
- Study completionNov 2008
Why it stopped: Inclusion-rate does not seem feasible anymore to obtain te required number of patients before the end of the trial.
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- M. Oudkerk Pool, Prof., Principal investigator, Isala Klieniken, Zwolle, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449813
- Sponsor's protocol ID
- BY1023/NL511
- Status last verified
- May 2008
- First submitted
- 2 Mar 2007
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- 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
- The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms
- ClinicalTrials.gov ID
- NCT00449813
- Acronym / sponsor ID
- BY1023/NL511
- Keywords
- Gastroesophageal reflux disease (GERD), Non erosive reflux disease (NERD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion-rate does not seem feasible anymore to obtain te required number of patients before the end of the trial.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 21 Mar 2007 (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.
The aim of the study is to compare two different endpoint measures: heartburn as assessed by the physicians versus gastroesophageal reflux disease (GERD)-related symptoms as assessed by the patient using the ReQuest™ questionnaire. The assessment is made in GERD-patients treated with a daily dose of 40 mg oral pantoprazole over an 8-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. | Active comparator | Drug: Pantoprazole40 mg Pantoprazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Outpatients of at least 18 years of age
- History of GERD-related symptoms of at least 6 months prior to baseline visit
- Endoscopically-confirmed GERD or non-erosive GERD
Key exclusion criteria (7 listed)
- Zollinger-Ellison syndrome or other gastric hypersecretory condition
- Acute peptic ulcer and/or ulcer complications
- Pyloric stenosis
- Severe or unstable cardiovascular, pulmonary, and/or endocrine disease
- Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of reliable contraception in women of child-bearing potential
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 |
|---|---|---|
| Pantoprazole40 mg Pantoprazole | Drug | 1. |
Primary outcome
Rate of misclassification on day 14 based on heartburn as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-gastrointestinal (GI) questionnaire
Time frame: 8 weeks
1 secondary outcome
Rate of misclassification on day 14 based on acid regurgitation as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-GI questionnaire
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Inclusion-rate does not seem feasible anymore to obtain te required number of patients before the end of the trial.). Results are not available in the source record.
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.
M. Oudkerk Pool, Prof. principal investigator
Isala Klieniken, Zwolle, The Netherlands
15 sites in 2 countries: 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 Disease and Non-erosive Reflux Disease, run by Takeda at 15 sites in 2 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 4 inclusion and 7 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 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 15 sites in Switzerland, Netherlands. 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 was stopped early (reason given: Inclusion-rate does not seem feasible anymore to obtain te required number of patients before the end of the trial.). 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?
Rate of misclassification on day 14 based on heartburn as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-gastrointestinal (GI) questionnaire (time frame: 8 weeks). 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.