Clinical trials: Management, Medication Therapy
Early Breast Cancer
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer
This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC)…
- Trial name
- FeDeriCa (NCT03493854)
- Testing
- Cyclophosphamide, Doxorubicin, Docetaxel
- Where
- 107 sites in United States, Argentina and 17 more
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C
Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone
Otherwise healthy subjects who are currently bein maintained on either methadone or buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at least 30 days will be administered BI 201335 daily to…
- Trial name
- NCT01637922
- Testing
- BI 201335
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Boehringer Ingelheim
Alcoholic Cirrhosis
Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis
The goal of this clinical trial is to evaluate the efficacy and safety of Cellgram-LC in patients with alcoholic cirrhosis. The main questions it aims to answer are: Is Cellgram-LC superior to best supportive care (BSC) in…
- Trial name
- Cellgram-LC (NCT04689152)
- Testing
- Cellgram-LC, Best Supportive Care (BSC)
- Where
- 15 sites in South Korea
- Volunteers
- 200 people
- Sponsor
- Pharmicell Co., Ltd.
Dengue
Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) in Adolescents in Non-Endemic Area(s)
The purpose of this study was to describe the neutralizing antibody response against each dengue serotype at 1 month post second dose of TDV or placebo in dengue-naive adolescent participants.
- Trial name
- NCT03341637
- Testing
- Tetravalent Dengue Vaccine (TDV)
- Where
- 5 sites in Mexico
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Takeda
Chemotherapy-induced Nausea and Vomiting, Prophylaxis
Evaluate Bioequivalence of Palonosetron (0.25mg/5mL)
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of palonosetron after intravenous administration of palonosetron in healthy volunteers under fasting conditions.
- Trial name
- NCT04585412
- Testing
- Palonosetron
- Where
- Taiwan
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
Inflammatory Bowel Diseases, Colitis, Ulcerative
A Study on How Vedolizumab is Given and the Outcomes for Adults With Inflammatory Bowel Disease (VARIETY-Belgium)
IBD consists of either ulcerative colitis or Crohn's disease. The main aim of this study is to describe real-world treatment patterns in adults with moderate to severe ulcerative colitis or Crohn's disease when treated with…
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohns Disease
- Trial name
- NCT04959851
- Where
- 10 sites in Belgium
- Volunteers
- 185 people
- Sponsor
- Takeda
Duodenal Ulcer
Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer
The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.
- Trial name
- NCT01452724
- Testing
- TAK-438, Lansoprazole
- Where
- 64 sites in Japan
- Volunteers
- 372 people
- Sponsor
- Takeda
Healthy
Bioequivalence of Two Different Generations of Drug Product of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers
The objective was to demonstrate the bioequivalence of capsules made from 2 different drug product batches. The reference batch was representative of the current commercial drug product and of the pivotal Phase III batches.
- Trial name
- NCT02171520
- Testing
- Dabigatran etexilate generation I, Dabigatran etexilate generation II
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Arthritis, Rheumatoid
Safety and Efficacy of Meloxicam Compared to Other Nonsteroidal Antiinflammatory Drugs (NSAIDs) in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm Syndrome
Study to assess the safety profile of meloxicam by comparing incidence of gastrointestinal adverse events of meloxicam with that of NSAID in the routine daily therapeutic situation.
- Trial name
- NCT02180516
- Testing
- Meloxicam, Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac
- Volunteers
- 9,984 people
- Sponsor
- Boehringer Ingelheim
Non-Small Cell Lung Cancer (NSCLC)
A Study to Evaluate the Impact of Management Strategies on Gastrointestinal-Related Adverse Events in Participants With Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations Receiving TAK-788
The purpose of the study is to characterize the incidence and severity of TAK-788-associated diarrhea in previously treated participants with locally advanced or metastatic non-small-cell lung cancer (NSCLC) whose tumors harbor…
- Trial name
- NCT04576208
- Testing
- TAK-788, Antidiarrheal prophylaxis
- Sponsor
- Takeda
Ketamine-Induced Brain Activity Changes, Psychotic-like Symptoms
Effects of TAK-063 on Preventing Ketamine-Induced Brain Activity Changes as Well as Psychotic-Like Symptoms in Healthy Male Adults
The purpose of this study is to determine whether ketamine-induced brain activity changes are modulated by TAK-063 administration using neuroimaging battery tests.
- Trial name
- NCT01892189
- Testing
- Ketamine, TAK-063
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteer
A Study of TAK-951 in Healthy Adults
It is hoped that a medicine called TAK-951 will eventually be used to treat nausea and vomiting. Before then, the sponsor needs to understand how the body processes TAK-951 in healthy adults.
- Trial name
- NCT04486950
- Testing
- TAK-951
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
Study to Assess the Effects of Daily Administration of Pioglitazone on Brain Hemodynamics in Healthy Elderly Participants
The purpose of this study is to assess the effects of pioglitazone, once daily (QD), on brain hemodynamics in healthy elderly participants.
- Trial name
- NCT01456117
- Testing
- Pioglitazone
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Takeda
Multiple Myeloma
A Survey on NINLARO Risk Management Plan (RMP) Material Utilization Among Pharmacists in Japan
This is a survey among pharmacists who have instructed NINLARO therapy in ixazomib, lenalidomide and dexamethasone (IRD) dosing to patients with relapsed/refractory multiple myeloma (rrMM).
- Trial name
- NCT05882279
- Testing
- No Intervention
- Where
- Japan
- Volunteers
- 330 people
- Sponsor
- Takeda
Astrocytoma, Grade IV, Giant Cell Glioblastoma
Natural Killer Cell (CYNK-001) IV Infusion or IT Administration in Adults With Recurrent GBM
This study will find the maximum safe dose (MSD) or maximum tolerated dose (MTD) of CYNK-001 which are NK cells derived from human placental CD34+ cells and culture-expanded.
- Conditions
- Astrocytoma, Grade IV, Giant Cell Glioblastoma, Glioblastoma Multiforme, Cyclophosphamide
- Trial name
- CYNK001GBM01 (NCT04489420)
- Testing
- CYNK001-IV, CYNK001-IT
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Celularity Incorporated
Bladder Neoplasm, Neoplasm Recurrence, Local
Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer
This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be conducted in approximately 120 investigational sites worldwide.
- Conditions
- Bladder Neoplasm, Neoplasm Recurrence, Local, Transitional Cell, Carcinoma, Carcinoma in Situ
- Trial name
- EMBARC-RF (NCT01200992)
- Testing
- EN3348, Mitomycin C
- Where
- 72 sites in United States, Canada and 4 more
- Volunteers
- 84 people
- Sponsor
- Bioniche Life Sciences Inc.
Premature Ejaculation
Evaluation of the Safety and Effectiveness of the vPatch Device
Multi-center, international, prospective, randomized, double-blind, two-arms, sham-controlled, first-in-human clinical investigation.
- Trial name
- NCT03942367
- Testing
- Active Device (vPatch)
- Where
- 3 sites in Israel, Italy
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Virility Medical Ltd.
Heart Failure
Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure
The INTERVENE-HF study is a prospective, non-randomized, multi-center (US only), investigational, feasibility study. The purpose of this study is to characterize safety of managing heart failure patients with integrated device…
- Trial name
- NCT02698241
- Testing
- Diagnostic & Medication Management
- Where
- 8 sites in United States
- Volunteers
- 79 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Myeloid Leukemia, Chronic, Myeloid Leukemia, Chronic, Accelerated-Phase
Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)
This will be an open label, multi-center study of up to 77 patients with CML in chronic, accelerated or blast phase who have developed resistance to or have failed previous treatment with Gleevec (imatinib mesylate).
- Conditions
- Myeloid Leukemia, Chronic, Myeloid Leukemia, Chronic, Accelerated-Phase, Blast Phase, Myeloid Leukemia, Chronic, Chronic-Phase
- Trial name
- NCT00114959
- Testing
- Homoharringtonine, Imatinib Mesylate
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- ChemGenex Pharmaceuticals
Movement Disorders, Essential Tremor
ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders
The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a tool for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in patients with treatment-refractory symptoms of…
- Conditions
- Movement Disorders, Essential Tremor, Holmes Tremor, Parkinson's Disease
- Trial name
- NCT02252380
- Testing
- Transcranial ExAblate System
- Where
- 2 sites in Canada
- Volunteers
- 10 people
- Sponsor
- InSightec