Gastroesophageal RefluxPhase 2NCT02743949
Comparison of Vonoprazan to Esomeprazole in Participants With Symptomatic GERD Who Responded Partially to a High Dose of Proton Pump Inhibitor (PPI)
A Phase 2 study testing Vonoprazan and Esomeprazole in people with Gastroesophageal Reflux, run by Takeda at 39 sites in 6 countries.
Trial summary
The purpose of this study is to determine the effect of vonoprazan compared to esomeprazole for preventing heartburn symptoms over a 4-week treatment period in participants who have a partial response to treatment with esomeprazole. 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?
- Vonoprazan and Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 39 sitesin 6 countries
- Study dates
- 14 Jul 2016to 12 Oct 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Is a man or a woman and ≥18 years of age, at the time of the Screening visit.
- Has a documented history of symptoms of both heartburn (burning pain) and acid regurgitation prior to entry into the study.
- The subject has a medical history of ≥ 8 weeks of persistent heartburn symptoms in the presence of regurgitation symptoms (persistent heartburn symptoms defined as heartburn symptoms on ≥ 2 days a week) that are troublesome despite appropriate and correctly performed treatment with a PPI at standard doses.
- Is ≥85% compliant at taking their Run-in medication and completing their e-Diary. Compliance for taking the Run-in medication is defined as the medication provided (esomeprazole and placebo) taken for 85% of the 6 weeks Run-in Period (or on 36 of 42 days of the Run-in Period).Compliance for the e-Diary is defined as the percentage of scheduled assessments that are completed based on 2 assessments per day (daytime and nighttime). For randomization, 85% compliance is required and is defined as 12 of 14 assessments completed over the 7-day period (Day -21 to Day-14) prior to the single blind Placebo Run-in Period.
- Has a partial response to a PPI defined as having heartburn on 2 to 5 days and regurgitation on at least one day of the last week (Week 4) of a 4 week PPI Run-In Period with esomeprazole 40 mg and an increase of at least 2 symptom days of heartburn in the last week of a 2 week Placebo Run-In Period (4 to 7 symptom days) and at least one symptom day with regurgitation compared with the last week of the PPI Run-In Period.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 4 weeks after last dose of the study medication.
Who cannot join
- Has received any investigational compound within 30 days prior to the Screening Visit.
- Has received vonoprazan in a previous clinical study.
- Is an immediate family member, study site employee, is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling), or may have consented under duress.
- Has, in the judgment of the investigator, clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at Screening.
- Has a history of erosive esophagitis of Los Angeles (LA) Classification Grade B severity or worse prior to screening or at Screening endoscopy.
- Has a history of or any coexisting diseases affecting the esophagus (eg, Barrett's esophagus, eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, or esophageal stricture), history of radiation therapy or cryotherapy to the esophagus, caustic trauma, or physiochemical trauma such as sclerotherapy to the esophagus.
Show all 26Show fewer
- Has "alarm features" in symptomatology, including odynophagia, severe dysphagia, bleeding, weight loss, anemia, and blood in stool, pointing to a possible malignant disease of the gastrointestinal (GI) tract. Participants displaying "alarm symptoms" in addition to the "typical" gastroesophageal reflux disease (GERD) symptoms may be included based on endoscopic exclusion of malignancy.
- Has current or historical chest pain due to cardiac diseases (eg, within one year).
- Has had surgical treatment for GERD (eg, cardiaplasty), dilation of an esophageal stricture (other than Schatzki ring) or gastric or duodenal surgery, except simple oversew of an ulcer or endoscopic polypectomy of benign polyps.
- Has active gastric or duodenal ulcers which have been confirmed by endoscopy within 30 days prior to Screening. Gastric or duodenal erosions are not exclusionary, unless considered severe and symptomatic by the investigator.
- Has had an acute upper gastrointestinal hemorrhage within 30 days prior to Screening.
- Has current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
- Has current or historical evidence of eosinophilic esophagitis (evidence may be based on the following: missing response to acid suppressive therapy, the presence of eosinophilia in histological probes of the esophageal mucosa, a normal pH profile of the distal esophagus, symptoms of dysphagia and food impaction). The exclusion of participants based on a predominance of the "typical" eosinophilic esophagitis symptoms only (as above) is considered acceptable. However, in participants with a predominance of "typical" symptoms and co-existing significant dysphagia and food impaction, the syndrome should be excluded by endoscopy with biopsy.
- Has a documented history (within 6 months prior to screening) of functional dyspepsia (suggested by the presence of one or more of the following symptoms: epigastric pain, postprandial fullness or early satiety), or irritable bowel syndrome or other gastrointestinal diseases which are not acid-related, and therefore, are nonresponsive to gastric acid-blocking treatment.
- Has a documented history of familial adenomatous polyposis.
- Has known intolerance, hypersensitivity or allergies to any PPI or their components (including lansoprazole, dexlansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole), any component of vonoprazan, or antacid(s) selected as rescue medication for this study.
- Has a history of alcohol abuse, illegal drug use, or drug addiction within the 12 months prior to Screening, or regularly consumes >21 units of alcohol (1 unit = 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week. Participants must have a negative drug screen at Screening.
- Has evidence of a serious uncontrolled concomitant disease including: clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, systemic, or endocrine disease or other abnormality (other than the disease being studied), which may impact the ability of the participant to participate or potentially confound the study results.
- Has planned, or is likely to require, in-patient surgery during the course of the study.
- Has a history of cancer (except basal cell carcinoma of the skin) within 3 years prior to Screening.
- Is known to have acquired immunodeficiency syndrome or chronic hepatitis due to any etiology.
- Has abnormal laboratory values at Screening that suggest a clinically significant underlying disease or condition that may prevent the participant from completing the study.
- Has an alanine aminotransferase (ALT), aspartate aminotransferase (AST) or T-bilirubin level which exceeds upper limit of normal (ULN) set by the testing laboratory at the Screening.
- If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
- Is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study.
- In the opinion of the investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.
Trial locations and contacts
39 sites in 6 countries.
39 sites in 6 countries
Bulgaria11 sites
DCC 'Sv. Pantaleymon' OOD
Pleven, 5800
UMHAT "Kaspela", EOOD
Plovdiv, 4002
MHAT - Ruse, AD
Rousse, 7002
MHAT "Hadzhi Dimitar", OOD
Sliven, 8800
NMTH "Tsar Boris III"
Sofia, 1233
"City Clinic UMHAC" EOOD
Sofia, 1407
MHAT 'Tokuda Hospital Sofia', EAD
Sofia, 1407
UMHAT "Sv. Ivan Rilski", EAD
Sofia, 1431
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
Sofia, 1527
Fourth MHAT - Sofia EAD
Sofia, 1606
UMHAT "SofiaMed", OOD
Sofia, 1797
Poland11 sites
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
Bialystok, 15-275
NZOZ Inter-Med
Częstochowa, 42-217
Centrum Medyczne Plejady
Krakow, 30-349
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, 31-009
Centrum Medyczne Medyk
Rzeszów, 35-055
Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski
Sopot, 81-756
SONOMED Sp.z o.o
Szczecin, 71-685
Niepubliczny Zaklad Opieki Zdrowotnej Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z
Torun, 87-100
Nzoz Vivamed
Warsaw, 03-580
LexMedica Osrodek Badan Klinicznych
Wroclaw, 53-114
EMC Instytut Medyczny S.A.
Wroclaw, 54-144
Estonia6 sites
OU Innomedica
Tallinn, 10117
Merekivi Perearstid OU
Tallinn, 10617
Merelahe Family Doctors Centre
Tallinn, 10617
West Tallinn Central Hospital
Tallinn, 10617
North Estonia Medical Centre Foundation
Tallinn, 13419
Tartu University Hospital
Tartu, 51014
Belgium5 sites
Medif
Gozée, 6534
SPRL Dr Yvan CALOZET
Grigomont, 6887
UZ Leuven
Leuven, 3000
SPRL MG Balthazar & Ballard
Natoye, 5360
Mortelmans, Jaak
Oostham, 3945
United Kingdom5 sites
CPS Research
Glasgow, Strathclyde, G20 0XA
Whipps Cross University Hospital
London, Greater London, E11 1NR
Plympton Health Centre
Plymouth, Devon, PL7 1AD
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG
Sheepcot Medical Centre
Watford, Hertfordshire, WD25 0EA
About this study
Official title: A Randomized, Double-Blind, Proof-of-Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Once Daily Oral Vonoprazan 20 mg or Vonoprazan 40 mg Compared to Esomeprazole 40 mg for the Treatment of Subjects With Symptomatic Gastro-Esophageal Reflux Disease Who Have a Partial Response Following Treatment With a High Dose of Proton Pump Inhibitor
The purpose of this study is to determine the effect of vonoprazan compared to esomeprazole for preventing heartburn symptoms over a 4-week treatment period in participants who have a partial response to treatment with esomeprazole.
Read the detailed description
The drug being tested in this study is called vonoprazan. Vonoprazan is being tested to treat people who have symptomatic gastroesophageal reflux disease (GERD) with a partial response to treatment with a high dose of esomeprazole. This study will look at improvement in heartburn symptoms in participants who take vonoprazan compared to esomeprazole.
The study will enroll approximately 213 patients. All participants will receive esomeprazole or esomeprazole placebo-matching capsules (this is a capsule that looks like esomeprazole but has no active ingredient) during a 7-week run-in period. Participants will then be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- Esomeprazole 40 mg
- Vonoprazan 20 mg
- Vonoprazan 40 mg
All participants will be asked to take one capsule at the same time each day throughout the study. All participants will be asked to record heartburn symptoms in a diary every morning upon waking and every evening before going to sleep.
This multi-center trial will be conducted in Europe. The overall time to participate in this study is 12 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 1 week after the last dose of study drug for a follow-up assessment.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Vonoprazan, Esomeprazole, Esomeprazole Placebo
- Keywords
- Drug therapy
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Also called TAK-438
Vonoprazan over-encapsulated capsules
EsomeprazoleDrug
Esomeprazole over-encapsulated tablets
Esomeprazole PlaceboDrug
Esomeprazole placebo-matching capsules
| Study group | Role | What they receive |
|---|---|---|
| Esomeprazole 40 mg | Active comparator | Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by esomeprazole 40 mg, over encapsulated tablets, orally, once daily for 4 weeks during the active treatment period. Receives: Drug: Vonoprazan; Drug: Esomeprazole; Drug: Esomeprazole Placebo |
| Vonoprazan 20 mg | Experimental | Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by vonoprazan 20 mg, over-encapsulated capsules, orally, once daily for 4 weeks during the treatment period. Receives: Drug: Vonoprazan; Drug: Esomeprazole; Drug: Esomeprazole Placebo |
| Vonoprazan 40 mg | Experimental | Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by vonoprazan 40 mg, over-encapsulated capsules, orally, once daily for 4 weeks during the active treatment period. Receives: Drug: Esomeprazole; Drug: Esomeprazole Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Heartburn-Free 24-Hour Periods (Day and Night) During 4 Weeks of Treatment
Participants used the Reflux Symptom Questionnaire Electronic Diary (RESQ-eD) every morning upon waking and every evening before going to sleep to document the presence of daytime and nighttime heartburn and regurgitation. The percentage of heartburn-free (HBF) 24-hour periods was calculated for each participant using the following formula: (total 24-hour periods that are heartburn free / total 24-hour periods for which both a daytime and nighttime result is marked) x 100%.
Measured: 4 Weeks
Secondary outcomes (1)
Percentage of Participants With ≥1 Sustained Resolution of Heartburn During the 4-Week Treatment Period
≥1 sustained resolution of heartburn is defined as ≥7 consecutive days without both daytime and nighttime heartburn anytime during the 4-week treatment period. Daytime and nighttime heartburn were documented by all participants using the Reflux Symptom Questionnaire Electronic Diary (RESQ-eD).
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start14 Jul 2016
- Primary completion5 Oct 2018
- Study completion12 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743949
- Sponsor's protocol ID
- Vonoprazan-2001
- Other IDs
- U1111-1172-2373, 2015-001154-14, 16/LO/0285, 2015
- Status last verified
- Feb 2020
- First submitted
- 14 Apr 2016
- Last updated
- 18 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Proof-of-Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Once Daily Oral Vonoprazan 20 mg or Vonoprazan 40 mg Compared to Esomeprazole 40 mg for the Treatment of Subjects With Symptomatic Gastro-Esophageal Reflux Disease Who Have a Partial Response Following Treatment With a High Dose of Proton Pump Inhibitor
- ClinicalTrials.gov ID
- NCT02743949
- Acronym / sponsor ID
- Vonoprazan-2001
- Conditions
- Gastroesophageal Reflux
- Keywords
- Drug therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2016 (actual)
- Primary completion
- 5 Oct 2018 (actual)
- Study completion
- 12 Oct 2018 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Posted 18 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of vonoprazan compared to esomeprazole for preventing heartburn symptoms over a 4-week treatment period in participants who have a partial response to treatment with esomeprazole.
Detailed description
The drug being tested in this study is called vonoprazan. Vonoprazan is being tested to treat people who have symptomatic gastroesophageal reflux disease (GERD) with a partial response to treatment with a high dose of esomeprazole. This study will look at improvement in heartburn symptoms in participants who take vonoprazan compared to esomeprazole.
The study will enroll approximately 213 patients. All participants will receive esomeprazole or esomeprazole placebo-matching capsules (this is a capsule that looks like esomeprazole but has no active ingredient) during a 7-week run-in period. Participants will then be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- Esomeprazole 40 mg
- Vonoprazan 20 mg
- Vonoprazan 40 mg
All participants will be asked to take one capsule at the same time each day throughout the study. All participants will be asked to record heartburn symptoms in a diary every morning upon waking and every evening before going to sleep.
This multi-center trial will be conducted in Europe. The overall time to participate in this study is 12 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 1 week after the last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Esomeprazole 40 mg | Active comparator | Drug: Vonoprazan, Drug: Esomeprazole, Drug: Esomeprazole PlaceboEsomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by esomeprazole 40 mg, over encapsulated tablets, orally, once daily for 4 weeks during the active treatment period. |
| Vonoprazan 20 mg | Experimental | Drug: Vonoprazan, Drug: Esomeprazole, Drug: Esomeprazole PlaceboEsomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by vonoprazan 20 mg, over-encapsulated capsules, orally, once daily for 4 weeks during the treatment period. |
| Vonoprazan 40 mg | Experimental | Drug: Esomeprazole, Drug: Esomeprazole PlaceboEsomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by vonoprazan 40 mg, over-encapsulated capsules, orally, once daily for 4 weeks during the active treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Is a man or a woman and ≥18 years of age, at the time of the Screening visit.
- Has a documented history of symptoms of both heartburn (burning pain) and acid regurgitation prior to entry into the study.
- The subject has a medical history of ≥ 8 weeks of persistent heartburn symptoms in the presence of regurgitation symptoms (persistent heartburn symptoms defined as heartburn symptoms on ≥ 2 days a week) that are troublesome despite appropriate and correctly performed treatment with a PPI at standard doses.
Key exclusion criteria (26 listed)
- Has received any investigational compound within 30 days prior to the Screening Visit.
- Has received vonoprazan in a previous clinical study.
- Is an immediate family member, study site employee, is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling), or may have consented under duress.
- Has, in the judgment of the investigator, clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at Screening.
- Has a history of erosive esophagitis of Los Angeles (LA) Classification Grade B severity or worse prior to screening or at Screening endoscopy.
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 |
|---|---|---|
| VonoprazanAlso: TAK-438Vonoprazan over-encapsulated capsules | Drug | Esomeprazole 40 mg, Vonoprazan 20 mg |
| EsomeprazoleEsomeprazole over-encapsulated tablets | Drug | Esomeprazole 40 mg, Vonoprazan 20 mg, Vonoprazan 40 mg |
| Esomeprazole PlaceboEsomeprazole placebo-matching capsules | Drug | Esomeprazole 40 mg, Vonoprazan 20 mg, Vonoprazan 40 mg |
Primary outcome
Percentage of Heartburn-Free 24-Hour Periods (Day and Night) During 4 Weeks of Treatment
Time frame: 4 Weeks
Participants used the Reflux Symptom Questionnaire Electronic Diary (RESQ-eD) every morning upon waking and every evening before going to sleep to document the presence of daytime and nighttime heartburn and regurgitation. The percentage of heartburn-free (HBF) 24-hour periods was calculated for each participant using the following formula: (total 24-hour periods that are heartburn free / total 24-hour periods for which both a daytime and nighttime result is marked) x 100%.
1 secondary outcome
Percentage of Participants With ≥1 Sustained Resolution of Heartburn During the 4-Week Treatment Period
Time frame: 4 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Related trials for Gastroesophageal Reflux
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.
Medical Director Clinical Science study director
Takeda
39 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vonoprazan and Esomeprazole in people with Gastroesophageal Reflux, run by Takeda at 39 sites in 6 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 8 inclusion and 26 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: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Bulgaria, Poland, Estonia, Belgium, United Kingdom and 1 more country. 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 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?
Yes. Results are posted in the registry (first posted 18 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Heartburn-Free 24-Hour Periods (Day and Night) During 4 Weeks of Treatment (time frame: 4 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 18 Feb 2020.