Gastroesophageal RefluxPhase 4NCT00261339
Determination of a Questionnaire After Treatment With Pantoprazole at Full Dose and Half Dose in Adult Patients With Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/UK-506)
A Phase 4 study testing Pantoprazole in people with Gastroesophageal Reflux and GERD, run by Takeda at 45 sites in United Kingdom.
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, GERD, GORD
- What is being tested?
- Pantoprazole
- How many people
- 300 participants
- Where
- 45 sitesUnited Kingdom
- Study dates
- Aug 2005to not given
- 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:
- Written informed consent
- Outpatients of at least 18 years of age
- GERD
- Patients with symptoms of GERD
Main exclusion criteria:
- Signs, indicating other gastrointestinal diseases
- Other concomitant diseases
- Special restrictions for female patients
- Previous medication
- Concomitant medication
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United Kingdom45 sites
Altana Pharma/Nycomed
Antrim, BT41 3AE
Altana Pharma/Nycomed
Ashford, TW15 3RN
Altana Pharma/Nycomed
Aston Clinton, Aylesbury, HP22 5LB
Altana Pharma/Nycomed
Atherstone, Warwick, CV9 1EU
Altana Pharma/Nycomed
Bangor, Northern Ireland, BT19 1PP
Altana Pharma/Nycomed
Barry, CS62 7EB
Altana Pharma/Nycomed
Barry, Vale of Glamorgan, Cardiff, CF63 4HP
Altana Pharma/Nycomed
Bath, BA1 2SR
Altana Pharma/Nycomed
Bath, BA2 4BY
Altana Pharma/Nycomed
Belfast, BT5 7BP
Altana Pharma/Nycomed
Belfast, BT7 1DA
Altana Pharma/Nycomed
Bexhill-on-Sea, Easr Sussex, TN40 1JJ
Altana Pharma/Nycomed
Blackpool, FY3 7EN
Altana Pharma/Nycomed
Bradford on Avon, Wiltshire, BA15 1DQ
Altana Pharma/Nycomed
Cardiff (Wales), CF14 9BB
Altana Pharma/Nycomed
Chesterfield, S40 1LE
Altana Pharma/Nycomed
Chesterfield, S40 4TF
Altana Pharma/Nycomed
Chippenham, SN15 1HP
Altana Pharma/Nycomed
Chippenham, Wiltshire, SN15 2SB
Altana Pharma/Nycomed
Cookstown, BT80 8BG
Altana Pharma/Nycomed
Crawley, RH10 7DX
Altana Pharma/Nycomed
Crawley, West Sussex, RH10 1LL
Altana Pharma/Nycomed
Downpatrick, Northern Ireland, BT30 6HY
Altana Pharma/Nycomed
Dronfield, S18 1RU
Altana Pharma/Nycomed
Ely, CF5 4AE
Altana Pharma/Nycomed
Glasgow, G45 9AW
Altana Pharma/Nycomed
Hull, HU3 3BH
Altana Pharma/Nycomed
Kent, CT5 1BZ
Altana Pharma/Nycomed
Keresely End, Coventry, CV7 8LA
Altana Pharma/Nycomed
Leigh Lancs, WN7 2RB
Altana Pharma/Nycomed
Leigh on Sea, Essex, SS9 2SQ
Altana Pharma/Nycomed
Lisburn, BT28 1LU
Altana Pharma/Nycomed
Middlesex, HA6 2RN
Altana Pharma/Nycomed
New Street, Ledbury, HR8 2DX
Altana Pharma/Nycomed
Saint George's Way, Sunderland, SR2 7BW
Altana Pharma/Nycomed
Sheffield, S39DA
Altana Pharma/Nycomed
Sheffield, S5 7QB
Altana Pharma/Nycomed
Slough, Berks, SI2 1HD
Altana Pharma/Nycomed
Somerset, BA111EZ
Altana Pharma/Nycomed
Southdown, Bath, BA2 1NH
Altana Pharma/Nycomed
Sunbury on Thames, Middlesex, TW16 6RH
Altana Pharma/Nycomed
Trowbridge, BA14 9AR
Altana Pharma/Nycomed
Trowbridge, Wilts, BA14 7EG
Altana Pharma/Nycomed
Warminster Wiltshire, BA12 9AA
Altana Pharma/Nycomed
Watford, WD25 0EA
About this study
Official title: PRISM: Determination of the Performance Characteristics of ReQuest (TradeMark) in Practice in the Stepped Down Management of GORD
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. 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 to treatment. Therefore, a questionnaire was developed to assess GERD symptoms ('ReQuest TradeMark in Practice'). An important point to consider when using such a questionnaire is to follow the patients´ medical response to treatment and note whether a patient needs to change dosing, such as changing from full dose to half dose, or vice versa.
The aim of the study is to determine the value of the questionnaire ('ReQuest TradeMark in Practice') according to treating physicians' clinical judgment when using pantoprazole at full and half dose. The study duration consists of a pre-treatment periods (0-2 weeks) and two treatment period (8 weeks each). During the first treatment period, pantoprazole will be administered once daily at full dose (40 mg). During the second treatment period, pantoprazole will be administered once daily at half dose (20 mg). The study will provide further data on safety and tolerability of pantoprazole.
- Conditions
- Gastroesophageal Reflux, GERD, GORD
- 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.
GERD symptom score after 8 weeks of treatment (prior to stepping down from full dose to half dose) for patients not being symptomatically relieved from GERD after 16 weeks of treatment
Secondary outcomes (7)
Symptom relief rates
symptom status (compared with pre-treatment)
time to reach first relief from reflux disease related symptoms
time to reach sustained symptom relief
relief rates from reflux disease related complaints
influence of the H. pylori-status on the symptom relief rates
safety.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study startAug 2005
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Professor of Primary Care, Principal investigator, Centre for Primary and Community Care, Sunderland, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261339
- Sponsor's protocol ID
- BY1023/UK-506
- Status last verified
- Dec 2006
- First submitted
- 2 Dec 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
- PRISM: Determination of the Performance Characteristics of ReQuest (TradeMark) in Practice in the Stepped Down Management of GORD
- ClinicalTrials.gov ID
- NCT00261339
- Acronym / sponsor ID
- BY1023/UK-506
- Conditions
- Gastroesophageal Reflux, GERD, GORD
- Keywords
- Gastroesophageal Reflux, Gastroesophageal Reflux Disease, Pantoprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- First posted
- 5 Dec 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. 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 to treatment. Therefore, a questionnaire was developed to assess GERD symptoms ('ReQuest TradeMark in Practice'). An important point to consider when using such a questionnaire is to follow the patients´ medical response to treatment and note whether a patient needs to change dosing, such as changing from full dose to half dose, or vice versa.
The aim of the study is to determine the value of the questionnaire ('ReQuest TradeMark in Practice') according to treating physicians' clinical judgment when using pantoprazole at full and half dose. The study duration consists of a pre-treatment periods (0-2 weeks) and two treatment period (8 weeks each). During the first treatment period, pantoprazole will be administered once daily at full dose (40 mg). During the second treatment period, pantoprazole will be administered once daily at half dose (20 mg). The study will provide further data on safety and tolerability of pantoprazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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
GERD symptom score after 8 weeks of treatment (prior to stepping down from full dose to half dose) for patients not being symptomatically relieved from GERD after 16 weeks of treatment
7 secondary outcomes
Symptom relief rates
symptom status (compared with pre-treatment)
time to reach first relief from reflux disease related symptoms
time to reach sustained symptom relief
relief rates from reflux disease related complaints
influence of the H. pylori-status on the symptom relief rates
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.
Professor of Primary Care principal investigator
Centre for Primary and Community Care, Sunderland, United Kingdom
45 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 and GERD, run by Takeda at 45 sites in United Kingdom.
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 45 sites in United Kingdom. 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?
GERD symptom score after 8 weeks of treatment (prior to stepping down from full dose to half dose) for patients not being symptomatically relieved from GERD after 16 weeks 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.