Clinical trials: Drug Use Disorders
Microscopic Polyangiitis (MPA), Granulomatosis With Polyangiitis (GPA)
Special Drug Use-results Survey for Long-term Use（Avacopan）
The purpose of this survey is evaluating the safety and efficacy of long-term administration of avacopan for Japanese patients with microscopic polyangiitis or granulomatosis with polyangiitis under actual conditions of use.
- Trial name
- NCT06758271
- Testing
- Avacopan
- Where
- Japan
- Volunteers
- 250 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
ARDS Due to COVID-19
Surfactant-BL in Adult Acute Respiratory Distress Syndrome Due to COVID-19
The purpose of this study is to prove the efficacy and safety Surfactant-BL, administered by inhalation in adult hospitalized patients with ARDS due to COVID-19.
- Trial name
- NCT04568018
- Testing
- Surfactant
- Where
- Russia
- Volunteers
- 120 people
- Sponsor
- Biosurf LLC.
Arteriovenous Fistula
Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae
The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm.
- Trial name
- AVR (NCT02746159)
- Testing
- Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9004
- Where
- 26 sites in Austria, France and 11 more
- Volunteers
- 320 people
- Sponsor
- C. R. Bard
Opioid Use Disorder
A Stepped-Wedge Cluster Randomized Trial of a Digital App to Support Medication-Assisted Treatment in Individuals With Opioid Use Disorder
The goal of this clinical trial is to learn if a mobile health app called Recovery Connect can help people stay in treatment for opioid use disorder.
- Trial name
- SMART-OUD (NCT07140926)
- Testing
- Recovery Connect
- Where
- 9 sites in United States
- Volunteers
- 1,524 people
- Sponsor
- Bright Therapeutics
Osteoarthritis, Knee, Osteoarthritis, Hip
Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"
To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.
- Trial name
- NCT00139776
- Testing
- Celecoxib
- Where
- 124 sites in United States, Belgium and 6 more
- Volunteers
- 875 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Antidiuretic Hormone, Inappropriate Secretion
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
The purpose of this study is to confirm the safety of tolvaptan in patients with hyponatremia in syndrome of inappropriate antidiuretic hormone secretion (SIADH) in Japan
- Trial name
- NCT04790175
- Testing
- Tolvaptan (SAMSCA)
- Where
- Japan
- Volunteers
- 300 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Diabetes Mellitus, Type 2
Long Term Daily Use of JARDIANCE® Tablets in Japanese Patients With Type 2 Diabetes Mellitus
Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus
- Trial name
- NCT02489942
- Testing
- Jardiance
- Where
- Japan
- Volunteers
- 8,145 people
- Sponsor
- Boehringer Ingelheim
Acute Myeloid Leukemia
Extension Study, Pilot, Compassionate Use of Azacitidine 300 mg Film Coated Tablets for Acute Myeloid Leukaemia (AML) Patients
Extension study, pilot, single-arm, compassionate use of Hikma Azacitidine 300 mg Film coated tablets test product for the Acute Myeloid Leukaemia (AML) patients who completed Hikma bioequivalence study with protocol number…
- Trial name
- NCT06572982
- Testing
- Azacitidine
- Where
- United Arab Emirates
- Volunteers
- 20 people
- Sponsor
- Hikma Pharmaceuticals LLC
Overactive Bladder, Cardiovascular Disease
Specified Drug Use-results Survey of Betanis Tablets for Patients With Coexisting Cardiovascular Disease
This purpose of this study is to investigate the effects of mirabegron on the cardiovascular system in patients with overactive bladder with current or a history of cardiovascular disease.
- Trial name
- NCT02570035
- Testing
- Mirabegron
- Where
- 28 sites in Japan
- Volunteers
- 316 people
- Sponsor
- Astellas Pharma Inc
Osteoporosis
Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month Treatment Survey)
The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) in osteoporosis patients in daily medical practice, as well as to examine "the status of treatment compliance" …
- Trial name
- NCT02089997
- Testing
- Sodium Risedronate
- Where
- 2 sites in Japan
- Volunteers
- 3,304 people
- Sponsor
- Takeda
Renal Cell Carcinoma
Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
The objective of this investigation is to determine the following items in all patients receiving Torisel for a certain period after marketing: 1. Confirmation of efficacy and safety for medical practice use. 2.
- Trial name
- NCT01210482
- Testing
- Temsirolimus
- Where
- Japan
- Volunteers
- 1,050 people
- Sponsor
- Pfizer
Peripheral Artery Disease (PAD)
Walking Effect of Long Term Ticagrelor in Subjects With PAD Who Have Undergone EVR
To compare the effect of ticagrelor versus aspirin on the change in peak walking time, evaluated on the graded treadmill test, from one to 26 weeks post-revascularization in patients with peripheral artery disease who have…
- Trial name
- TI-PAD EVR (NCT02227368)
- Testing
- Ticagrelor, Comparator
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Non-tuberculous Mycobacterial Diseases, Tuberculosis
Safety And Efficacy Of Rifabutin In HIV Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Conditions
- Non-tuberculous Mycobacterial Diseases, Tuberculosis, Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
- Trial name
- NCT00810446
- Testing
- rifabutin
- Volunteers
- 72 people
- Sponsor
- Pfizer
HIV Infection
Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients
The investigation will be conducted for the purpose of determining the condition of occurrence of Adverse Events under the actual post-marketing use of Zithromac 600mg Tablet, verifying the therapeutic effects, detecting unknown…
- Trial name
- NCT01227395
- Testing
- Azithromycin
- Volunteers
- 476 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
A Real-world Analysis of Concomitant Medication Use Among Metastatic Breast Cancer Patients Treated With CDK4/6 Inhibitors
This is a retrospective cohort study to assess the real-world analysis of concomitant medication use among metastatic breast cancer patients treated with CDK4/6 inhibitors utilizing the US Optum research administrative claims…
- Trial name
- NCT05141240
- Testing
- Ribiciclib, Palbociclib, Abemaciclib
- Where
- United States
- Volunteers
- 4,650 people
- Sponsor
- Novartis Pharmaceuticals
Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use
Food and Insulin Effect on QT/QTC Interval of ECG
Moxifloxacin is routinely used as a probe to confirm assay sensitivity in thorough electrocardiogram (ECG) studies. It has been shown that a meal shortens the QT interval, which may affect pharmacokinetics (PK) and/or…
- Conditions
- Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use, C-Peptide Effects on the QT/QTc Interval, Moxifloxacin ECG Profile in Fed and Fasted State
- Trial name
- C11035 (NCT01642485)
- Testing
- Moxifloxacin 400 mg fasted, FDA breakfast, Continental breakfast
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Richmond Pharmacology Limited
Spinal Cord Injury
Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Spinal Cord Injury
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of pain associated with spinal cord injury.
- Trial name
- NCT01135108
- Testing
- KAI-1678
- Where
- Australia
- Volunteers
- 5 people
- Sponsor
- KAI Pharmaceuticals
Pulmonary Disease, Chronic Obstructive
Drug Utilization Study for Olodaterol
This study aims to characterise the use of single-agent olodaterol and single-agent indacaterol, the only marketed long-acting beta2-agonist (LABA)s authorised for chronic obstructive pulmonary disease (COPD), but not for asthma…
- Trial name
- NCT03030638
- Testing
- Olodaterol, Indacaterol
- Where
- 3 sites in Denmark, France and 1 more
- Volunteers
- 27,606 people
- Sponsor
- Boehringer Ingelheim
Epilepsy
A Survey of Midazolam in People With Status Epilepticus
This study is a survey in Japan of midazolam oromucosal solution used to treat people with status epilepticus. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the…
- Trial name
- NCT05313308
- Testing
- Midazolam
- Where
- Japan
- Volunteers
- 50 people
- Sponsor
- Clinigen K.K.
Hereditary Angioedema (HAE)
Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers
This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of icatibant administered to adult Japanese subjects.
- Trial name
- NCT02045264
- Testing
- Icatibant (30 mg)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Shire