chufangao/CTO huggingface dataset:
Clinical trial NCT03548051: Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD)
Official title: Phase 1/2 Placebo Controlled, Partially-Blinded Clinical Trial to Assess the Safety and Efficacy of Microbial Restoration by Enema With Banked and Thawed Processed Stool in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD)
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Low enrollment
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-11
Primary completion date: 2021-01-13
Completion date: 2021-01-13
Clinical trial NCT03075527: A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma
Official title: A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Criteria not met for second stage at time of interim analysis
Enrollment: 19.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-04-10
Primary completion date: 2019-06-07
Completion date: 2024-09-30
Plan to share individual participant data: NO
Clinical trial NCT02133885: Study 2: Effect of Minocycline Treatment on Drug-Resistant Hypertensive Patients
Official title: Angiotensin and Neuroimmune Activation in Hypertension
Sponsor: University of Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: This study was never started and no participants were enrolled.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-01-30
Primary completion date: 2024-03-31
Completion date: 2024-03-31
Clinical trial NCT04037865: A Renal Impairment Study for PF-06651600
Official title: A PHASE 1, NON-RANDOMIZED, OPEN LABEL, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF 06651600 IN PARTICIPANTS WITH RENAL IMPAIRMENT AND IN HEALTHY PARTICIPANTS WITH NORMAL RENAL FUNCTION
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated due to extensive Covid-19 delay.
Enrollment: 8.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-08-19
Primary completion date: 2020-03-31
Completion date: 2020-03-31
Baseline population: The baseline analysis population included all participants enrolled in the study.
Limitations and caveats: Since the study was terminated, the results of this study was not complete and the interpretation of the study results was limited.
Plan to share individual participant data: NO
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 NCT02719015: Dose Escalation and Cohort Expansion of Safety and Tolerability Study of Intratumoral rAd.CD40L (ISF35) in Combination of Systemic Pembrolizumab in Patients With Refractory Metastatic Melanoma
Official title: Phase I/II Dose Escalation and Cohort Expansion of Safety and Tolerability Study of Intratumoral rAd.CD40L (ISF35) in Combination of Systemic Pembrolizumab in Patients With Refractory Metastatic Melanoma
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: No IND Serial #
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-31
Primary completion date: 2022-03-31
Completion date: 2022-03-31
Clinical trial NCT04483414: 68Ga PSMA-11 PET/CT in Recurrent Prostate Cancer
Official title: The Role of 68Gallium PSMA-11 in Biochemical Recurrence in Prostate Cancer and in Known Metastatic Prostate Cancer and in the Evaluation of Treatment Response After Salvage Therapy
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study was closed since no participants were enrolled.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-19
Primary completion date: 2023-04-05
Completion date: 2023-04-05
Plan to share individual participant data: NO
Clinical trial NCT03383887: DAW1033D in Obstructive Sleep Apnea
Official title: Effect of DAW1033D on Obstructive Sleep Apnea and Its Phenotypic Traits
Acronym: OSAstimD
Sponsor: Brigham and Women's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 11.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-13
Primary completion date: 2020-01-20
Completion date: 2020-01-20
Plan to share individual participant data: NO
Clinical trial NCT04399395: Naltrexone/Bupropion (Mysimba) to Optimize Weight Outcomes After Obesity Surgery
Official title: Treatment With Naltrexone/Buprpion (Mysimba) to Optimize Weight Outcomes After Bariatric Surgery
Sponsor: Oslo University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Covid-pandemic
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-01
Primary completion date: 2022-09-30
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT04247594: Dose Escalation Study to Evaluate the Safety, Tolerability, PK and PD of Voxelotor in Patients With SCD
Official title: A Phase 2, Open Label, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Voxelotor in Patients With Sickle Cell Disease
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Data will not inform further development of Voxelotor
Enrollment: 6.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-01-09
Primary completion date: 2021-06-08
Completion date: 2021-06-08
Baseline population: Subjects treated with at least one dose of Voxelotor
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 NCT02915263: The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes
Official title: A Double-Blind, Randomized, Placebo-Controlled Trial To Evaluate The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes
Sponsor: Beth Israel Deaconess Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Funding withdrawn in the midst of the COVID pandemic
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-11
Primary completion date: 2022-02-01
Completion date: 2022-02-01
Baseline population: A total of 13 participants were enrolled before COVID-19 pandemic shut down research activities. A total of 8 participants were able to complete the study, 5 stopped mid-study due to the COVID shutdown.
Plan to share individual participant data: NO
Clinical trial NCT03944707: Study of Efficacy and Safety of LOU064 in Inadequately Controlled Asthma Patients
Official title: A Randomized, Subject- and Investigator-blinded, Placebo-controlled Study to Assess the Efficacy and Safety of LOU064 in Patients With Inadequately Controlled Asthma
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Company decision
Enrollment: 76.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-18
Primary completion date: 2020-04-27
Completion date: 2020-04-27
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Clinical trial NCT02219490: A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Official title: An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes With ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I)
Acronym: TOPAZ-I
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1596.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-10-30
Primary completion date: 2021-05-13
Completion date: 2021-05-13
Baseline population: Safety population: All participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications
IPD time frame: For details on when studies are available for sharing, please refer to the link below.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT03084861: A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy
Official title: A Multicenter, Randomized, Open-label, Two-arms Phase I/II Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy
Sponsor: Banc de Sang i Teixits (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Low recruitment. No safety issue associated.
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-02-24
Primary completion date: 2020-03-12
Completion date: 2020-03-12
Plan to share individual participant data: NO
Clinical trial NCT03824847: Immunomodulatory Effect of Macrolides in Naturally Occurring Influenza Virus Infections in the Community
Official title: Immunomodulatory Effect of Macrolides in Naturally Occurring Influenza Virus Infections in the Community
Sponsor: The University of Hong Kong (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: SUSPENDED 
Why stopped: Community recruitment suspended due to COVID-19
Enrollment: 100.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2023-06-01
Primary completion date: 2024-03-01
Completion date: 2024-09-01
Clinical trial NCT04518319: Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome
Official title: Clinical Comprehensive Intervention on Cognitive Impairment of Schizophrenia Patients With Metabolic Syndrome
Sponsor: Shanghai Mental Health Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: The COVID-19 affects the recruitment of patients.
Enrollment: 120.0 (ESTIMATED)
Number of arms: 4.0
Start date: 2020-10-01
Primary completion date: 2024-11-30
Completion date: 2024-11-30
Clinical trial NCT04057807: Peripheral Benzodiazepine Receptors (PBR28) Brain PET Imaging With Lipopolysaccharide Challenge for the Study of Microglia Function in Alzheimer's Disease
Official title: PBR28 Brain Positron Emission Tomography Imaging With Lipopolysaccharide (LPS) Challenge for the Study of Microglia Function in Alzheimer's Disease
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 18.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-15
Primary completion date: 2022-07-27
Completion date: 2022-07-27
Clinical trial NCT03729401: Personalization of Long-Term Antiplatelet Therapy - RAPID EXTEND
Official title: Personalization of Long-Term Antiplatelet Therapy Using a Novel Combined Demographic/Pharmacogenomic Strategy - The RAPID EXTEND Randomized Study
Acronym: RAPID EXTEND
Sponsor: Ottawa Heart Institute Research Corporation (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: SUSPENDED 
Why stopped: Testing supplies unavailable.
Enrollment: 390.0 (ESTIMATED)
Number of arms: 3.0
Start date: 2019-08-22
Primary completion date: 2024-03-31
Completion date: 2024-09-30
Plan to share individual participant data: NO
Clinical trial NCT03691974: Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 180.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-15
Primary completion date: 2020-01-30
Completion date: 2021-01-07
Clinical trial NCT00946192: Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes
Official title: Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 121.0 (ACTUAL)
Number of arms: 3.0
Start date: 2009-05-31
Primary completion date: 2020-02-29
Completion date: 2021-04-30
Baseline population: Athletes with amenorrhea
Clinical trial NCT01994265: Cognitive Impairment Related to Atrial Fibrillation Prevention Trial
Official title: Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin
Acronym: GIRAF
Sponsor: University of Sao Paulo (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 200.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-11-07
Primary completion date: 2021-03-09
Completion date: 2021-03-09
Clinical trial NCT05290740: Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery
Official title: Comparison of Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery: A Randomized, Controlled Trial
Sponsor: Kasr El Aini Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 158.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-11
Primary completion date: 2022-07-25
Completion date: 2022-07-25
Plan to share individual participant data: NO
IPD sharing description: protocol and data of this research could be available from the PI upon reasonable request
Clinical trial NCT03948334: A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients
Official title: A Randomized, Double Blind, Multicenter Extension to CZPL389A2203 Dose-ranging Study to Assess the Short-term and Long-term Safety and Efficacy of Oral ZPL389 With Concomitant Use of TCS and/or TCI in Adult Patients With Atopic Dermatitis.
Acronym: ZESTExt
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Core terminated due to lack of efficacy
Enrollment: 123.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-04
Primary completion date: 2020-07-23
Completion date: 2020-08-25
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT03102242: Atezolizumab Immunotherapy in Patients With Advanced NSCLC
Official title: Phase II Trial of Induction Immunotherapy With Atezolizumab for Patients With Unresectable Stage IIIA and IIIB NSCLC Eligible for Chemoradiotherapy With Curative Intent.
Sponsor: Alliance Foundation Trials, LLC. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 64.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-11-01
Primary completion date: 2020-06-01
Completion date: 2022-10-01
Plan to share individual participant data: NO
Clinical trial NCT04386447: Phase II RCT to Assess Efficacy of Intravenous Administration of Oxytocin in Patients Affected by COVID-19
Official title: Phase II, Multicenter, Open-label, Rct With an Adaptive Design, to Assess Efficacy of Intravenous Administration of Oxytocin in Hospitalized Patients Affected by COVID-19
Acronym: OsCOVID19
Sponsor: Azienda Ospedaliero-Universitaria di Parma (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The study was not approved by the Italian Medicines Agency (AIFA).
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-09-01
Primary completion date: 2020-10-31
Completion date: 2020-12-31
Clinical trial NCT03033732: A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse
Official title: Optimizing Patient Centered-Care: A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse (OPTIMA Trial)
Acronym: OPTIMA
Sponsor: Canadian Research Initiative in Substance Misuse (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 272.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-02
Primary completion date: 2020-03-31
Completion date: 2020-12-31
Plan to share individual participant data: NO
Clinical trial NCT03059355: Infusion of Umbilical Cord Versus Bone Marrow Derived Mesenchymal Stem Cells to Evaluate Cytokine Suppression.
Official title: A Phase I/II, Randomized, Placebo-controlled Comparative Study to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Bone Marrow (BM) Derived MSCs to Evaluate Cytokine Suppression in Patients With Chronic Inflammation Due to Metabolic Syndrome.
Acronym: CERES
Sponsor: University of Miami (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: COVID-19 Pandemic and lack of funding
Enrollment: 14.0 (ACTUAL)
Number of arms: 7.0
Start date: 2018-04-12
Primary completion date: 2020-03-23
Completion date: 2021-02-11
Baseline population: Randomized phase of the study was terminated after only 2 participants. No subjects were allocated to Group A or Group C in the randomized phase of the trial.
Limitations and caveats: Funding timeline was not met due to the coronavirus disease 2019 (COVID-19) pandemic. No additional funding was provided, therefore the study had to be terminated early.
Plan to share individual participant data: NO
Clinical trial NCT03434158: Olaparib Maintenance in Patients With MCRPC After Docetaxel Treatment Reaching Partial or Stable Response (IMANOL)
Official title: Phase II Trial Evaluating Olaparib Maintenance in Patients With MCRPC After Docetaxel Treatment Reaching Partial or Stable Response.
Acronym: IMANOL
Sponsor: Spanish Oncology Genito-Urinary Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-02-06
Primary completion date: 2022-05-12
Completion date: 2022-05-12
Clinical trial NCT01594229: A Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Combination With Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
Official title: A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Combination With Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 1.0
Start date: 2012-05-21
Primary completion date: 2020-07-14
Completion date: 2020-07-14
Plan to share individual participant data: NO
Clinical trial NCT02432417: The Addition of Chloroquine to Chemoradiation for Glioblastoma,
Official title: A Phase II Randomized Controlled Trial for the Addition of Chloroquine, an Autophagy Inhibitor, to Concurrent Chemoradiation for Newly Diagnosed Glioblastoma
Sponsor: Maastricht Radiation Oncology (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The study was withdrawn due to a lack of funding. The researchers were unable to secure the necessary financial support to continue and complete the trial.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-11-10
Primary completion date: 2023-11-10
Completion date: 2023-11-10
Clinical trial NCT05132803: TA-CIN Vaccine With Anti-PD-1 Therapy in Recurrent HPV16-associated Cancers
Official title: A Feasibility Trial to Assess Intratumoral Injection of TA-CIN With Anti-PD-1 Therapy for Recurrent HPV16-associated Cancers
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: The study team decided not to move forward with the study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-08-31
Primary completion date: 2022-01-18
Completion date: 2022-01-18
Clinical trial NCT04091087: Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis
Official title: A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Local Tolerability of Crisaborole Ointment, 2%, in Adult Participants With Stasis Dermatitis Without Active Skin Ulceration
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 66.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-26
Primary completion date: 2021-10-19
Completion date: 2021-10-19
Baseline population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized.
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.