| 1 |
NCT03334838 |
Not yet recruiting |
Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients - Dietary Habits Study |
|
- Drug: Nifurtimox (Lampit, BAYA2502)
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- AUC(0-tlast) of nifurtimox
- Cmax of nifurtimox
- Number of participants with adverse events as a measure of safety and tolerability
- (and 2 more...)
|
36 |
All |
18 Years to 45 Years (Adult) |
NCT03334838 |
16006 |
|
April 8, 2019 |
October 28, 2019 |
January 20, 2020 |
November 7, 2017 |
February 15, 2019 |
|
- FP Clinical Pharma
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina
|
|
| 2 |
NCT03350295 |
Completed |
Study Will Evaluate the Relative Bioavailability, Safety, and Tolerability of Single Doses of Nifurtimox 30 mg Tablets Exhibiting Different in Vitro Dissolution Characteristics, and to Evaluate the Relative Bioavailability of Nifurtimox 30 mg and 120 mg |
|
- Drug: Nifurtimox (Lampit, BAYA2502)
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- AUC(0-tlast) of nifurtimox
- Cmax of nifurtimox
- AUC of nifurtimox
- (and 4 more...)
|
48 |
All |
18 Years to 45 Years (Adult) |
NCT03350295 |
16007 |
|
June 14, 2018 |
September 18, 2018 |
December 14, 2018 |
November 22, 2017 |
January 8, 2019 |
|
- FP Clinical Pharma
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina
|
|
| 3 |
NCT02606864 |
Completed |
Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients |
|
- Drug: Nifurtimox (BAYa2502)
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Area under the drug-concentration vs. time curve of nifurtimox from time 0 to the last data point[AUC(0-tlast)]
- Plasma concentration nifurtimox characterized by Cmax
- Plasma concentration of nifurtimox characterized by tmax
- (and 2 more...)
|
36 |
All |
18 Years to 45 Years (Adult) |
NCT02606864 |
16005 |
|
December 2015 |
April 2016 |
August 2016 |
November 17, 2015 |
November 15, 2016 |
|
- Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
|
|
| 4 |
NCT03708133 |
Recruiting |
Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet Formulation |
|
- Drug: Nifurtimox (Lampit, BAYA2502)_Test
- Drug: Nifurtimox (Lampit, BAYA2502)_Reference
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- AUC
- AUC(0-tlast)
- Cmax
- (and 5 more...)
|
24 |
All |
18 Years to 45 Years (Adult) |
NCT03708133 |
19500 |
|
December 5, 2018 |
March 29, 2019 |
June 21, 2019 |
October 17, 2018 |
January 24, 2019 |
|
- FP Clinical Pharma
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina
|
|
| 5 |
NCT01165112 |
Completed
Has Results |
Bendamustine Hydrochloride, Rituximab, Etoposide, and Carboplatin in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Hodgkin Lymphoma |
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Hodgkin Lymphoma
|
- Drug: Bendamustine Hydrochloride
- Drug: Carboplatin
- Biological: Rituximab
- (and 2 more...)
|
Interventional
|
Phase 1
Phase 2 |
- University of Washington
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximally Tolerated Dose of Bendamustine Hydrochloride That Can be Combined With Rituximab, Carboplatin, and Etoposide Chemotherapy in Patients With Relapsed or Refractory Lymphoid Malignancies
- Safety and Toxicity of This Regimen
- Preliminary Assessment of the Efficacy of This Regimen
- Ability to Proceed to Peripheral Blood Stem Cell (PBSC) Collection Following Treatment (Impact of This Regimen on Stem Cell Reserve)
|
48 |
All |
18 Years and older (Adult, Older Adult) |
NCT01165112 |
PSOC 2502
NCI-2010-00907
P30CA015704 |
TREC |
September 2010 |
June 2015 |
June 2015 |
July 19, 2010 |
December 5, 2018 |
May 25, 2017 |
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
|
|
| 6 |
NCT01927224 |
Completed |
Study to Assess Bioequivalence of 30 and 120 mg Nifurtimox Tablets in Chronic Chagas' Patients |
|
- Drug: Nifurtimox (BAYa2502) (4 x 30 mg tablet)
- Drug: Nifurtimox (BAYa2502) (slurry of 4 x 30 mg tablets in tap water)
- Drug: Nifurtimox (BAYa2502) (120 mg tablet)
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Area under the drug-concentration vs. time curve of nifurtimox from time 0 to the last data point [AUC(0-tn)]
- Maximum drug concentration of nifurtimox in plasma (Cmax)
- Number of participants with adverse events as a measure of safety and tolerability
|
37 |
All |
18 Years to 45 Years (Adult) |
NCT01927224 |
16004 |
|
November 2013 |
May 2014 |
September 2014 |
August 22, 2013 |
October 16, 2015 |
|
- Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
|
|
| 7 |
NCT01258140 |
Completed |
Detection of Pulmonary Embolism With Low-dose CT Pulmonary Angiography |
|
- Radiation: Computed tomography pulmonary angiography
|
Interventional
|
Not Applicable |
- University Hospital Inselspital, Berne
- Stanley Thomas Johnson Foundation, Bern, Switzerland
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Diagnostic
|
- Evidence of Pulmonary Embolism (PE) on CT pulmonary angiography (CTPA)
- Accuracy of normal- and low-dose CTPA on composite reference standard
- Evidence of PE or deep venous thrombosis in 90 days following CTPA
- (and 3 more...)
|
504 |
All |
18 Years and older (Adult, Older Adult) |
NCT01258140 |
120/08 |
REDOPED |
September 2008 |
December 2012 |
December 2012 |
December 10, 2010 |
January 23, 2013 |
|
- Institute of Diagnostic, Interventional and Pediatric Radiology, University Hospital Bern
Bern, Switzerland
|
|
| 8 |
NCT02625974 |
Active, not recruiting |
Prospective Study of a Pediatric Nifurtimox Formulation for Chagas' Disease |
|
- Drug: Nifurtimox (BAYA2502)
- Drug: Nifurtimox (BAYA2502) followed by Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Incidence rate of seronegative conversion for all subjects (Part 1)
- Incidence rate of sero-reduction for subjects ≥ 8 months to <18 years of age (Part 1)
- Incidence rate of seronegative conversion for all subjects (Part 2)
- (and 10 more...)
|
330 |
All |
up to 17 Years (Child) |
NCT02625974 |
16027 |
CHICO |
January 27, 2016 |
July 25, 2018 |
August 9, 2021 |
December 9, 2015 |
January 4, 2019 |
|
- La Plata, Buenos Aires, Argentina
- Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina
- Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina
- (and 22 more...)
|
|
| 9 |
NCT00299013 |
Completed |
Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis |
|
- Drug: COLAL-PRED®
- Drug: Prednisolone
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Disease activity index
- Cortisol levels
- Simple clinical colitis activity index
- (and 3 more...)
|
796 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT00299013 |
ATL2502/020/CL |
|
March 2006 |
April 2008 |
April 2008 |
March 6, 2006 |
April 25, 2008 |
|
- Research Site
Bankstown, New South Wales, Australia - Research Site
Bedford Park, South Australia, Australia - Research Site
Parkville, Victoria, Australia - (and 83 more...)
|
|
| 10 |
NCT03844386 |
Recruiting
New |
Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults |
|
- Biological: MVA.tHIVconsv3
- Biological: MVA.tHIVconsv4
- Other: Placebo
|
Interventional
|
Phase 1 |
- University of North Carolina, Chapel Hill
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percent of Participants with a Grade 3 or higher Treatment-Related Adverse Event (AE)
- Percent of Participants with a Grade 1 or higher Treatment-Related Adverse Event (AE)
|
27 |
All |
18 Years to 45 Years (Adult) |
NCT03844386 |
18-2502
U01AI131310-01
IGHID 11810 |
M&M |
February 2019 |
August 2020 |
August 2020 |
February 18, 2019 |
February 18, 2019 |
|
- University of North Carolina Health Care
Chapel Hill, North Carolina, United States
|
|
| 11 |
NCT00944697 |
Completed
Has Results |
A Study to Demonstrate the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Addition to Pregabalin Compared to Pregabalin Alone in Opioid-naïve Subjects Treated With Pregabalin Suffering From Moderate to Severe Pain Due to Diabetic Polyneuropathy |
- Moderate to Severe Pain Due to Diabetic Polyneuropathy
|
- Drug: Oxycodone Naloxone
- Drug: Placebo tablets
|
Interventional
|
Phase 2 |
- Mundipharma Research GmbH & Co KG
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Basic Science
|
- Short Form McGill Pain Score.
|
98 |
All |
18 Years and older (Adult, Older Adult) |
NCT00944697 |
OXN2502
2008-005815-17 |
|
July 2009 |
March 2010 |
April 2010 |
July 23, 2009 |
August 17, 2012 |
February 28, 2012 |
- Dr Oliver Emrich
Ludwigshafen, Germany
|
|
| 12 |
NCT01006265 |
Completed |
Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis |
|
- Drug: ACT-128800 Dose 1
- Drug: Placebo
- Drug: ACT-128800 Dose 2
- Drug: ACT-128800 Dose 3
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Cumulative number of new gadolinium-enhancing lesions per patient recorded on four-weekly T1-weighted magnetic resonance imaging (MRI) scans
- Annualized confirmed relapse rate
- Time to first confirmed relapse
|
464 |
All |
18 Years to 55 Years (Adult) |
NCT01006265 |
AC-058B201 |
|
October 1, 2009 |
June 1, 2011 |
July 1, 2011 |
November 2, 2009 |
April 4, 2017 |
|
- Clinical Investigative Site 3132
Scottsdale, Arizona, United States - Clinical Investigative Site 3100
Tuscon, Arizona, United States - Clinical Investigative Site 3115
Sacremento, California, United States - (and 112 more...)
|
|
| 13 |
NCT01093326 |
Active, not recruiting |
Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis |
|
- Drug: Ponesimod 10 mg
- Drug: Ponesimod 20 mg
- Drug: Ponesimod 40 mg
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Annualized confirmed relapse rate
- Time to first confirmed relapse
- Time to 3 month confirmed disability progression up to end of the study
- Time to 6 month confirmed disability progression up to end of the study
|
353 |
All |
18 Years to 55 Years (Adult) |
NCT01093326 |
AC-058B202 |
|
May 12, 2010 |
December 15, 2021 |
December 15, 2021 |
March 25, 2010 |
January 23, 2019 |
|
- Clinical Investigative Site 3100
Phoenix, Arizona, United States - Clinical Investigative Site 3132
Scottsdale, Arizona, United States - Clinical Investigative Site 3115
Sacramento, California, United States - (and 78 more...)
|
|
| 14 |
NCT03230838 |
Recruiting |
MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034) |
- Complicated Urinary Tract Infection
- Pyelonephritis
|
- Drug: Ceftolozane
- Drug: Tazobactam
- Drug: Meropenem
|
Interventional
|
Phase 2 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Adverse Events (AEs)
- Discontinuations
- Clinical response of cure
- Microbiological eradication of all baseline pathogens
|
120 |
All |
up to 17 Years (Child) |
NCT03230838 |
7625A-034
2016-004153-32 |
|
April 26, 2018 |
September 6, 2020 |
September 6, 2020 |
July 26, 2017 |
February 15, 2019 |
|
- Children's Hospital - Los Angeles ( Site 2509)
Los Angeles, California, United States - Children's Hospital of Orange County ( Site 2502)
Orange, California, United States - Rady Children's Hospital-San Diego ( Site 2505)
San Diego, California, United States - (and 45 more...)
|
|
| 15 |
NCT00793624 |
Completed
Has Results |
Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I |
- Pulmonary Disease, Chronic Obstructive
|
- Drug: Olodaterol (BI 1744)
- Drug: Formoterol
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks
- Trough FEV1 Response at Week 24
- Mahler Transitional Dyspnea Index Focal Score at 24 Weeks
- (and 59 more...)
|
906 |
All |
40 Years and older (Adult, Older Adult) |
NCT00793624 |
1222.13
2008-001933-84 |
|
February 2009 |
December 2010 |
|
November 19, 2008 |
June 27, 2014 |
June 5, 2014 |
- 1222.13.2401 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina - 1222.13.2403 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina - 1222.13.2402 Boehringer Ingelheim Investigational Site
Mar del Plata, Argentina - (and 90 more...)
|
|
| 16 |
NCT03217136 |
Recruiting |
MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abdominal Infection (cIAI) (MK-7625A-035) |
- Complicated Intra-Abdominal Infection
|
- Drug: Ceftolozane
- Drug: Tazobactam
- Drug: Metronidazole
- (and 2 more...)
|
Interventional
|
Phase 2 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Adverse Events (AEs)
- Discontinuations
- Clinical response of cure
- Microbiological eradication of all baseline pathogens
|
120 |
All |
up to 17 Years (Child) |
NCT03217136 |
7625A-035
2016-004820-41 |
|
April 3, 2018 |
September 6, 2020 |
September 6, 2020 |
July 13, 2017 |
February 15, 2019 |
|
- Children's Hospital - Los Angeles ( Site 2508)
Los Angeles, California, United States - Children's Hospital of Orange County ( Site 2502)
Orange, California, United States - Rady Children's Hospital-San Diego ( Site 2505)
San Diego, California, United States - (and 42 more...)
|
|
| 17 |
NCT02505542 |
Active, not recruiting |
Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo |
- Axial Spondyloarthrithis
- Ankylosing Spondylitis
|
- Biological: Certolizumab Pegol
- Other: Placebo
|
Interventional
|
Phase 3 |
- UCB BIOSCIENCES GmbH
- Parexel
- UCB Pharma
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of subjects in Part B who do not experience a flare
- Percentage of subjects achieving sustained remission in Part A
- Percentage of subjects in Ankylosing Spondylitis Disease Activity Score (ASDAS) disease activity categories in Part A
- (and 27 more...)
|
736 |
All |
18 Years to 45 Years (Adult) |
NCT02505542 |
AS0005
2015-000339-34 |
C-OPTIMISE |
July 2015 |
February 2019 |
April 2019 |
July 22, 2015 |
February 15, 2019 |
|
- As0005 2313
Glendale, Arizona, United States - As0005 2316
Mesa, Arizona, United States - As0005 2314
Phoenix, Arizona, United States - (and 105 more...)
|
|
| 18 |
NCT03486873 |
Recruiting |
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) |
|
- Biological: Pembrolizumab
- Drug: Standard of Care (SOC)
|
Interventional
|
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Survival (OS)
- Duration of Response (DOR) Per Evaluation Criteria Used in the Parent Study
- Duration of Complete Response (DOCR) Per Evaluation Criteria Used in the Parent Study
- (and 3 more...)
|
2300 |
All |
18 Years and older (Adult, Older Adult) |
NCT03486873 |
3475-587
MK-3475-587
2017-004417-42 |
|
August 21, 2018 |
May 10, 2028 |
May 10, 2028 |
April 3, 2018 |
February 15, 2019 |
|
- California Cancer Associates for Research & Excellence ( Site 0016)
Fresno, California, United States - The Angeles Clinic and Research Institute ( Site 0005)
Los Angeles, California, United States - UCLA Medical Center Hematology Oncology ( Site 0009)
Los Angeles, California, United States - (and 57 more...)
|
|
| 19 |
NCT03189719 |
Recruiting |
First-line Esophageal Carcinoma Study With Chemo vs. Chemo Plus Pembrolizumab (MK-3475-590/KEYNOTE-590) |
|
- Biological: Pembrolizumab
- Drug: Placebo
- Drug: Cisplatin
- Drug: 5-FU
|
Interventional
|
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in all participants
- PFS per RECIST Version 1.1 in PD-L1 biomarker-positive participants
- Overall Survival (OS) in all participants
- (and 9 more...)
|
700 |
All |
18 Years and older (Adult, Older Adult) |
NCT03189719 |
3475-590
2017-000958-19
173739 |
|
July 25, 2017 |
August 22, 2021 |
August 22, 2021 |
June 16, 2017 |
February 15, 2019 |
|
- Kaiser Permanente Southern California ( Site 0003)
Los Angeles, California, United States - The University of Chicago Medical Center ( Site 0001)
Chicago, Illinois, United States - University of Kansas ( Site 0029)
Westwood, Kansas, United States - (and 186 more...)
|
|
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