chufangao/CTO huggingface dataset:
Clinical trial NCT04325672: Convalescent Plasma to Limit Coronavirus Associated Complications
Official title: Convalescent Plasma to Limit Coronavirus Associated Complications: An Open Label, Phase 2A Study of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study stopped due to opening Expanded Access Protocol.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-04-01
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT03066453: Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic Fibrosis
Official title: Evaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis.
Acronym: TOBRAMUC
Sponsor: University Hospital, Lille (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: new treatment that changes the management of the disease
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-13
Primary completion date: 2020-01-16
Completion date: 2020-01-16
Plan to share individual participant data: NO
Clinical trial NCT05546411: A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer
Official title: A Phase 2 Study of Neoadjuvant NIS793 in Combination With mFOLFIRINOX in Resectable and Borderline Resectable Pancreatic Adenocarcinoma (PDAC)
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Novartis, the drug manufacturer of NIS793, notified Dana Farber Cancer Institute that they are stopping all clinical development of NIS793 in pancreatic cancer, effective immediately.
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-01-06
Primary completion date: 2023-08-16
Completion date: 2023-10-13
Plan to share individual participant data: YES
IPD sharing description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD time frame: Data can be shared no earlier than 1 year following the date of publication
IPD access criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Clinical trial NCT05780541: PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Official title: A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 (Trial H6: PF-07304814)
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The agent was withdrawn from development by the manufacturer after being placed on clinical hold by the US FDA.
Enrollment: 58.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-15
Primary completion date: 2022-04-06
Completion date: 2023-07-14
Clinical trial NCT02372409: Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors
Official title: A Pilot Study of Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low accruals and competing clinical trials
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-08-14
Primary completion date: 2023-03-23
Completion date: 2023-03-23
Limitations and caveats: The protocol stated that participants were to be followed for 5 years from participant registration or until death, whichever occurred first. The original consent that the participants signed stated that they would only be followed for 12 months after MLA. Once this issue was discovered, participants were contacted to be reconsented to be followed for 5 years; however, not all participants were able to be reconsented and that is why the results are late.
Plan to share individual participant data: NO
Clinical trial NCT04638153: A Study Of Safety, Tolerability And Effectiveness Of Recifercept In Children With Achondroplasia
Official title: A PHASE 2 MULTIPLE DOSE, RANDOMIZED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF RECIFERCEPT IN CHILDREN WITH ACHONDROPLASIA
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated due to lack of efficacy at any of the tested doses on 18th November 2022. The decision to terminate the study is not related to a safety concern.
Enrollment: 60.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-12-02
Primary completion date: 2023-01-16
Completion date: 2023-03-27
Baseline population: Baseline analysis population included all participants who received at least one dose of recifercept.
Limitations and caveats: The PK study cohort was not enrolled due to early study termination, therefore, the data of the PK cohort were not collected.
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT04908748: Efficacy and Safety of Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain
Official title: The Efficacy and Safety of an Esflurbiprofen Hydrogel Patch vs. Placebo in the Local Symptomatic and Short-term Treatment of Pain in Acute Strains, Sprains or Bruises of the Extremities Following Blunt Trauma, e.g. Sports Injuries.
Sponsor: Teikoku Seiyaku Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 200.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-20
Primary completion date: 2021-11-09
Completion date: 2021-12-15
Plan to share individual participant data: NO
Clinical trial NCT03960541: Efprezimod Alfa (CD24Fc, MK-7110) Administration to Decrease Low-Density Lipoprotein (LDL) and Inflammation in Human Immunodeficiency Virus (HIV) Patients (CALIBER) (MK-7110-003)
Official title: CD24Fc Administration to Decrease LDL and Inflammation in HIV Patients, Both as Markers of Efficacy and Cardiovascular Risk Reduction (CALIBER)
Acronym: CALIBER
Sponsor: Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Business Reasons
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-31
Primary completion date: 2021-05-27
Completion date: 2021-05-27
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04366232: Efficacy of Intravenous Anakinra and Ruxolitinib During COVID-19 Inflammation
Official title: Interleukin-1 (IL-1) and Interferon Gamma (IFNg) Inhibition During COVID 19 Inflammation: Randomized, Controlled Study Assessing Efficacy and Safety of Anakinra and Ruxolitinib
Acronym: JAKINCOV
Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: investigator decision
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-19
Primary completion date: 2020-10-02
Completion date: 2020-10-02
Plan to share individual participant data: NO
Clinical trial NCT02921737: TAS-102 (Lonsurf) in Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Post First Line Chemotherapy (UF-STO-PANC-003)
Official title: A Phase II Trial of TAS-102 (Lonsurf) in Patients With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma After Progression Through First Line Chemotherapy
Sponsor: University of Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: insufficient time to accrue sufficient subjects before end of funding
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-11-09
Primary completion date: 2020-07-26
Completion date: 2020-07-26
Plan to share individual participant data: NO
Clinical trial NCT04955262: A CD8 Positron Emission Tomography With Computed Tomography (PET/CT) Study Using ⁸⁹Zr Df-IAB22M2C in Patients With Metastatic Melanoma Receiving Bempegaldesleukin (NKTR-214) and Nivolumab
Official title: A Phase 1b, Open Label, Multicenter Study of Positron Emission Tomography With Computed Tomography (PET/CT) Using ⁸⁹Zr Df-IAB22M2C (CD8 PET/CT Tracer) in Patients With Metastatic Melanoma Receiving Bempegaldesleukin (NKTR-214) and Nivolumab
Sponsor: Nektar Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Did not initiate due to business reasons. IND is inactive.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-31
Primary completion date: 2021-06-30
Completion date: 2022-01-31
Plan to share individual participant data: NO
Clinical trial NCT00788125: Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
Official title: Dasatinib With Ifosfamide, Carboplatin, Etoposide: A Pediatric Phase I/II Trial
Sponsor: City of Hope Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Terminated early due a shift in resources after lackluster performance of the drug.
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2008-09-03
Primary completion date: 2010-04-30
Completion date: 2022-07-30
Clinical trial NCT03312530: A Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Participants With Relapsed and Refractory Multiple Myeloma
Official title: A Phase Ib/II Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Patients With Relapsed and Refractory Multiple Myeloma
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 49.0 (ACTUAL)
Number of arms: 5.0
Start date: 2017-11-13
Primary completion date: 2021-05-18
Completion date: 2021-05-18
Limitations and caveats: In March 2019, this study was placed on voluntary enrollment hold. In May 2019, after an informal efficacy review, the Sponsor decided not to remove the hold and discontinued further development of the combination.
Clinical trial NCT04044950: A Phase II Study of Neoadjuvant E7 TCR T Cell Immunotherapy for Borderline Resectable and Unresectable Stage I HPV-Associated Oropharyngeal Cancer
Official title: A Phase II Study of Neoadjuvant E7 TCR T Cell Immunotherapy for Borderline Resectable and Unresectable Stage I HPV-Associated Oropharyngeal Cancer
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The study was closed due to investigator discretion based on the lack of ability to recruit patients and research goals of the program.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-29
Primary completion date: 2020-09-17
Completion date: 2020-09-17
Clinical trial NCT04494659: A Drug-drug Interaction Trial to Evaluate the Pharmacokinetics Effect of Rifampicin on Famitinib
Official title: A Single Center, Single Arm, Open and Fixed Sequence Study to Investigate the Pharmacokinetic Effects of Rifampicin on Famitinib in Healthy Male Subjects
Sponsor: Jiangsu HengRui Medicine Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 21.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-07-20
Primary completion date: 2020-08-13
Completion date: 2020-08-31
Plan to share individual participant data: NO
Clinical trial NCT03325114: Safety and Efficacy of Chlorthalidone in Type 1 Diabetes
Official title: Safety and Efficacy of Chlorthalidone to Reduce Urinary Calcium Excretion in Adolescents/Yount Adult With Type 1 Diabetes
Sponsor: University of Rochester (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: COVID restrictions prohibit further study activies
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-06-28
Primary completion date: 2020-06-01
Completion date: 2020-06-01
Baseline population: Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.
Plan to share individual participant data: NO
IPD sharing description: Data will be available in aggregate. No plan to share individual data at present.
Clinical trial NCT04757090: 89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111
Official title: A Pilot Study of 89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Insufficient staff
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-31
Primary completion date: 2023-12-31
Completion date: 2023-12-31
Plan to share individual participant data: NO
Clinical trial NCT03626727: Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
Official title: Open-label Clinical Trial to Evaluate the Efficacy of Sodium Oxybate (Xyrem®) in the Treatment of Two Under-recognized Clinical Conditions: Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
Sponsor: Brigham and Women's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Target study population was extremely difficult to recruit and planned study budget was exceeded
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-09-30
Primary completion date: 2020-09-01
Completion date: 2020-09-01
Clinical trial NCT03883607: Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)
Official title: An Open Label, Randomized, Multicenter Study to Assess the Pharmacokinetic and Pharmacodynamic Profile and the Safety and Tolerability of Two Dose Levels of Elafibranor (80 mg and 120 mg) in Children and Adolescents, 8 to 17 Years of Age, With Nonalcoholic Steatohepatitis (NASH)
Sponsor: Genfit (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to lack of efficacy (but not due to safety) in a Phase 3 trial of elafibranor in adult participants with NASH and fibrosis, this study in pediatric NASH was prematurely terminated
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-25
Primary completion date: 2020-06-16
Completion date: 2020-06-16
Baseline population: Analysis was performed on intent-to-treat (ITT) population that had included participants who were randomized and had received at least 1 dose of the study drug.
Limitations and caveats: Due to lack of efficacy (but not due to safety) in a Phase 3 trial of elafibranor in adult participants with NASH and fibrosis, this study in pediatric NASH was prematurely terminated. Therefore, participants \>=12 to \<=17 years of age were only involved in this study.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03986970: The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention
Official title: Combined HIV Adolescent PrEP and Prevention: On Demand Pre-exposure Prophylaxis to Provide Protection From HIV in Men - Using Foreskin Tissue to Estimate Protection (Phase II)
Acronym: CHAPS
Sponsor: Wits Health Consortium (Pty) Ltd (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 72.0 (ACTUAL)
Number of arms: 9.0
Start date: 2019-11-11
Primary completion date: 2021-02-25
Completion date: 2021-02-25
Plan to share individual participant data: UNDECIDED
IPD sharing description: Data will be shared with callaborators.
Clinical trial NCT02516696: BiRd vs. Rd as Initial Therapy in Multiple Myeloma
Official title: Lenalidomide and Dexamethasone (Rd) Versus Clarithromycin [Biaxin®] / Lenalidomide [Revlimid®] / Dexamethasone (BiRd) as Initial Therapy in Multiple Myeloma
Acronym: BiRd vs Rd
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: low enrollment
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-02-29
Primary completion date: 2022-06-22
Completion date: 2022-07-22
Limitations and caveats: The significance of these results is limited by the study's low accrual. The study's low accrual was due in part to the COVID-19 pandemic.
Clinical trial NCT02746952: Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukaemia
Official title: Phase I, Open Label, Dose-escalation Study Followed by a Safety Expansion Part to Evaluate the Safety, Expansion and Persistence of a Single Dose of UCART19 (Allogeneic Engineered T-cells Expressing Anti-CD19 Chimeric Antigen Receptor), Administered Intravenously in Patients With Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukaemia (B-ALL)
Acronym: CALM
Sponsor: Servier (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-08-01
Primary completion date: 2020-07-28
Completion date: 2020-07-28
Plan to share individual participant data: YES
IPD sharing description: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
IPD time frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD access criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Clinical trial NCT05641545: IVAC-RCC-001: A Personalized Neoantigen Vaccine as Add-on to Standard of Care Checkpoint Inhibitor in Advanced/Metastatic RCC Patients
Official title: IVAC-RCC-001: A Personalized Neoantigen Vaccine as Add-on to Standard of Care Checkpoint Inhibitor in Advanced/Metastatic RCC Patients
Sponsor: SLK Kliniken Heilbronn GmbH (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Premature discontinuation due to üoor participant recruitment
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-10-17
Primary completion date: 2024-09-15
Completion date: 2024-09-15
Plan to share individual participant data: NO
Clinical trial NCT04192500: Safety and Immune Response of One Dose of OVX836 at Two Dose Levels, in Comparison to Influvac TetraTM, After Intramuscular Administration in Healthy Subjects Aged 18-65 Years
Official title: A Phase 2a, Single Center, Randomized, Double-blind, Controlled Study to Evaluate the Immunogenicity and the Safety of One Dose of OVX836 Influenza Vaccine at Two Dose Levels (90 µg and 180 μg), in Comparison to Influvac TetraTM, Quadrivalent Seasonal Influenza Sub-unit Vaccine, After Intramuscular Administration in Healthy Subjects Aged 18-65 Years
Sponsor: Osivax (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 300.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-12-11
Primary completion date: 2020-09-07
Completion date: 2020-09-07
Plan to share individual participant data: NO
Clinical trial NCT04591626: A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes
Official title: A Randomized, Double-Blind Trial Comparing the Effect of the Addition of Dulaglutide 1.5 mg Versus the Addition of Placebo to Titrated Basal Insulin on Glycemic Control in Chinese Patients With Type 2 Diabetes
Acronym: AWARD-CHN3
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 291.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-07
Primary completion date: 2022-04-28
Completion date: 2022-04-28
Baseline population: All randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT04657679: Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts
Official title: evaLuation of Variations pharmacokinEtics and phArmacogeNOmics of Ribociclib in rAce-based Cohorts: The LEANORA Study
Acronym: LEANORA
Sponsor: Georgetown University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Sufficient accrual into the African American/Black patient cohort and insufficient accrual into the NHW patient cohort.
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-20
Primary completion date: 2023-10-30
Completion date: 2023-10-30
Plan to share individual participant data: NO
Clinical trial NCT04799158: A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
Official title: A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg, 20 mg, and 40 mg Compared to Placebo for Relief of Episodic Heartburn in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
Sponsor: Phathom Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 458.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-03-25
Primary completion date: 2021-12-16
Completion date: 2022-01-17
Baseline population: On-Demand Treatment Period: The Safety On-Demand Set included all participants in the Safety Run-In Set who were randomized and treated at least one heartburn episode with randomized treatment during the On-Demand Treatment period.
Plan to share individual participant data: NO
IPD sharing description: Data from this study will be published; however, it is undecided if patient level data will be made available at this time.