Clinical trials: Medication Safety
Rheumatoid Arthritis
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis
This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug…
- Trial name
- C-early (NCT01519791)
- Testing
- Certolizumab Pegol, Methotrexate
- Where
- 178 sites in United States, Argentina and 20 more
- Volunteers
- 880 people
- Sponsor
- UCB Pharma SA
Gastroesophageal Reflux
Pharmacokinetic and Safety of Dexlansoprazole in Adolescents With Gastroesophageal Reflux Disease
The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole modified release (MR), once daily (QD), in adolescent subjects (age 12-17 years old) with Symptomatic Gastroesophageal Reflux Disease.
- Trial name
- NCT00847210
- Testing
- Dexlansoprazole MR
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Takeda
Beta-Thalassemia Major, Sickle Cell Disease
A Study Evaluating the Safety and Efficacy of LentiGlobin BB305 Drug Product in β-Thalassemia Major (Also Referred to as Transfusion-dependent β-Thalassemia [TDT]) and Sickle Cell Disease
This is a Phase 1/2, open label, safety, and efficacy study of the administration of LentiGlobin BB305 Drug Product to participants with either transfusion dependent beta-thalassemia (TDT) or sickle cell disease (SCD).
- Trial name
- NCT02151526
- Testing
- LentiGlobin BB305 Drug Product
- Where
- France
- Volunteers
- 7 people
- Sponsor
- Genetix Biotherapeutics Inc.
Opiate Dependence, Drug Dependence
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)
Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.
- Trial name
- NCT00605033
- Testing
- Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484, Subutex, Buprenorphine Hydrochloride, SCH 28444
- Volunteers
- 241 people
- Sponsor
- Indivior Inc.
Tardive Dyskinesia
A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia
The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
- Trial name
- KINECT 3 (NCT02274558)
- Testing
- NBI-98854
- Where
- 54 sites in United States, Canada and 1 more
- Volunteers
- 234 people
- Sponsor
- Neurocrine Biosciences
Central Precocious Puberty
A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants
The purpose of this study is to assess long-term safety and efficacy of leuprorelin in the treatment of Central Precocious Puberty (CPP).
- Trial name
- NCT02427958
- Testing
- Leuprorelin
- Where
- 9 sites in China
- Volunteers
- 307 people
- Sponsor
- Takeda
Hodgkin's Disease
Safety and Efficacy Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma
The purpose of this study is to find the highest safe dose of Iodine-131 Tositumomab (Bexxar®) that can be given to patients who have relapsed/refractory Hodgkin's lymphoma, what side effects these patients get when they take…
- Trial name
- NCT00484874
- Testing
- I-131 Tositumomab therapeutic regimen
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Solid Tumor, Adult, Breast Cancer
PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors
The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced…
- Conditions
- Solid Tumor, Adult, Breast Cancer, Non Small Cell Lung Cancer, Head and Neck Cancer
- Trial name
- NCT03149549
- Testing
- CX-2009
- Where
- 26 sites in United States, Netherlands and 2 more
- Volunteers
- 99 people
- Sponsor
- CytomX Therapeutics
Schizophrenia
Safety and Tolerability Study of Drug to Treat Schizophrenia
The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.
- Trial name
- NCT00044005
- Testing
- Lurasidone 20 mg, Lurasidone 40 mg, Lurasidone 80mg
- Where
- 26 sites in United States
- Volunteers
- 98 people
- Sponsor
- Sumitomo Pharma America, Inc.
Parkinson Disease
Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease
Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily use of Mirapex®-LA Tablets in patients with Parkinson's disease.
- Trial name
- NCT01525641
- Testing
- Mirapex LA
- Where
- 118 sites in Japan
- Volunteers
- 615 people
- Sponsor
- Boehringer Ingelheim
Colitis, Ulcerative, Crohn's Disease
A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease
The main aim of the study is to check for long-term side effects of Vedolizumab Subcutaneous (also known as Vedolizumab SC) in people with ulcerative colitis (UC) and Crohn's disease (CD).
- Trial name
- NCT02620046
- Testing
- Vedolizumab SC
- Where
- 301 sites in United States, Argentina and 31 more
- Volunteers
- 746 people
- Sponsor
- Takeda
Juvenile Idiopathic Arthritis
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to…
- Trial name
- NCT01230827
- Testing
- CNTO 148 (Golimumab), Methotrexate
- Where
- 35 sites in United States, Austria and 10 more
- Volunteers
- 173 people
- Sponsor
- Janssen Research & Development, LLC
Rheumatoid Arthritis, Psoriasis
A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis
The purpose of this study is to investigate experimental medication BMS-986251 taken by mouth in healthy patients and patients with average to very serious Psoriasis (a condition characterized by itchy, dry skin with a scaly…
- Conditions
- Rheumatoid Arthritis, Psoriasis, Ankylosing Spondylitis, Inflammatory Bowel Diseases
- Trial name
- NCT03329885
- Testing
- BMS-986251
- Where
- Netherlands
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Respiratory Syncytial Virus Infections
A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab
The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months.
- Trial name
- JUBILUS (NCT06042049)
- Testing
- Nirsevimab
- Where
- 9 sites in Japan
- Volunteers
- 33 people
- Sponsor
- AstraZeneca
Hypertension
One-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension
This purpose of this study is to evaluate the long-term safety and tolerability of azilsartan medoxomil in individuals with essential hypertension.
- Trial name
- NCT00695955
- Testing
- Azilsartan medoxomil with or without add-on chlorthalidone, Azilsartan medoxomil with or without add-on hydrochlorothiazide
- Where
- 41 sites in United States, Chile and 1 more
- Volunteers
- 669 people
- Sponsor
- Takeda
Diabetes, Diabetes Mellitus, Type 2
Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of liraglutide in subjects with type 2 diabetes and moderate renal impairment.
- Trial name
- NCT01620489
- Testing
- liraglutide
- Where
- 97 sites in United States, France and 4 more
- Volunteers
- 279 people
- Sponsor
- Novo Nordisk A/S
Crohn's Disease, Complex Perianal Fistula
Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.
- Trial name
- NCT04075825
- Testing
- Darvadstrocel
- Where
- 58 sites in United States, Belgium and 7 more
- Volunteers
- 150 people
- Sponsor
- Takeda
Presbyopia, Refractive Errors
Evaluation of the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (LNZ100) in the Treatment of Presbyopia
To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.
- Conditions
- Presbyopia, Refractive Errors, Eye Diseases
- Trial name
- NCT05431543
- Testing
- Aceclidine+Brimonidine combination ophthalmic solution, Aceclidine ophthalmic solution, Vehicle proprietary ophthalmic solution
- Where
- 5 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- LENZ Therapeutics, Inc
Tuberculosis, Pulmonary, Drug Sensitive, Tuberculosis, Pulmonary, Multi Drug-resistant
Shortening Treatment by Advancing Novel Drugs
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and treatment lengths from 4 to 6 months in subjects with…
- Trial name
- STAND (NCT02342886)
- Testing
- Moxifloxacin, PA-824, Pyrazinamide
- Where
- 26 sites in Georgia, Kenya and 6 more
- Volunteers
- 284 people
- Sponsor
- Global Alliance for TB Drug Development
Osteoporosis
Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice
This survey is conducted for preparing application material for re examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, and assessing the safety and efficacy profiles of VIVIANT in usual practice…
- Trial name
- NCT01793142
- Testing
- Viviant
- Where
- 60 sites in South Korea
- Volunteers
- 3,430 people
- Sponsor
- Pfizer
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