Clinical trials: Medication Safety
Quality of Life, Injection Site Reaction
Simultaneous mRNA COVID-19 and IIV4 Vaccination Study
This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID-19 vaccine either simultaneously or…
- Conditions
- Quality of Life, Injection Site Reaction, Adverse Drug Event, Systemic Reaction
- Trial name
- NCT05028361
- Testing
- mRNA COVID-19, IIV4
- Where
- 3 sites in United States
- Volunteers
- 348 people, healthy volunteers welcome
- Sponsor
- Duke University
Bacterial Infection, Multiple-drug Resistance
Intravenous Fosfomycin Pharmacokinetics Study
This is a Phase 1, open-label, multiple-dose trial conducted at a single center. The treatment period will consist of three 6 g doses (18 g) of ZTI-01 as a 1-hour intravenous (IV) infusion (+10 minute window).
- Conditions
- Bacterial Infection, Multiple-drug Resistance, Pathogen Resistance
- Trial name
- NCT03910673
- Testing
- Fosfomycin disodium
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Stomach Ulcer, Duodenal Ulcer
Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs
The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with nonsteroid…
- Trial name
- NCT00787254
- Testing
- Lansoprazole, Gefarnate
- Where
- 68 sites in Japan
- Volunteers
- 366 people
- Sponsor
- Takeda
Pulmonary TB
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB
This trial will assess the safety and efficacy of OPC-167832 combined with delamanid and bedaquiline in participants with drug-susceptible tuberculosis (DS-TB) administered for 17 weeks compared to rifampin, isoniazid…
- Trial name
- NCT05221502
- Testing
- Delamanid, Bedaquiline, RHEZ
- Where
- 6 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hypertension
A Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension
The purpose of this study is to determine the long term safety and tolerability of azilsartan medoxomil, once daily (QD), in participants with Essential Hypertension.
- Trial name
- NCT00696384
- Testing
- Azilsartan medoxomil, Azilsartan medoxomil, with or without chlorthalidone and other non-angiotensin II receptor blocker antihypertensive medications.
- Where
- 45 sites in United States, Argentina and 1 more
- Volunteers
- 418 people
- Sponsor
- Takeda
Rheumatoid Arthritis
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)
This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe rheumatoid arthritis who have an inadequate…
- Trial name
- NCT01235507
- Testing
- methotrexate, tocilizumab [RoActemra/Actemra]
- Where
- 3 sites in Bosnia and Herzegovina
- Volunteers
- 71 people
- Sponsor
- Hoffmann-La Roche
Multiple Myeloma
A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma
The main aims of this study are to test for any side effects from modakafusp alfa in combination therapy and to determine the recommended dose of combination therapy with modakafusp alfa.
- Trial name
- iinnovate-2 (NCT05556616)
- Testing
- Modakafusp alfa, Lenalidomide, Bortezomib
- Where
- 21 sites in United States, Belgium and 2 more
- Volunteers
- 15 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
Atrial Fibrillation
Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea
The primary purpose of this study is to evaluate comparative effectiveness and safety outcomes of therapies to prevent thromboembolic events in patients with nonvalvular atrial fibrillation by using Korean nationwide health…
- Trial name
- NCT03572972
- Testing
- Apixaban, Dabigatran, Rivaroxaban
- Where
- South Korea
- Volunteers
- 64,684 people
- Sponsor
- Pfizer
Medication Adherence
Development and Evaluation of an Electronic Health Record-based Medication Complete Communication (EMC2) Strategy
There is a well-documented need for effective interventions that can help patients understand and safely adhere to prescribed medications, particularly those with greater potential for harm if not taken correctly.
- Trial name
- NCT03652272
- Testing
- EMC2
- Where
- United States
- Volunteers
- 301 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Healthy Volunteers
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single- and Multiple-Doses of TAK-020 in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ascending single- and multiple-doses of TAK-020 in healthy participants.
- Trial name
- NCT02413255
- Testing
- TAK-020
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Takeda
Carcinoid Syndrome
Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms
The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.
- Trial name
- TELEPATH (NCT02026063)
- Testing
- Telotristat etiprate
- Where
- 43 sites in United States, Australia and 10 more
- Volunteers
- 124 people
- Sponsor
- Lexicon Pharmaceuticals
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.
Acute Pain
Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction
This study aims to evaluate the analgesic efficacy of single and multiple doses of a new fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in comparison to each single component.
- Trial name
- NCT04622735
- Testing
- nefopam hydrochloride 30mg / paracetamol 500mg X2, Paracetamol 500 Mg Oral Tablet X2, Nefopam HCl 30 MG Oral Tablet X2
- Where
- 19 sites in Belgium, France and 3 more
- Volunteers
- 321 people
- Sponsor
- Unither Pharmaceuticals, France
Coronary Artery Disease
The Dual Antiplatelet Therapy Study (DAPT Study)
The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety…
- Trial name
- NCT00977938
- Testing
- Clopidogrel & Aspirin, Prasugrel & Aspirin
- Where
- 256 sites in United States, Australia and 8 more
- Volunteers
- 25,682 people
- Sponsor
- Baim Institute for Clinical Research
Respiratory Syncytial Virus Infections
A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV
The purpose of the study is to learn about the safety and amount of sisunatovir in the blood of infants and children up to age 60 months.
- Trial name
- NCT06102174
- Testing
- Active
- Where
- 9 sites in United States, Japan and 1 more
- Volunteers
- 10 people
- Sponsor
- Pfizer
Rheumatoid Arthritis
A Study in Participants With Moderate to Severe Rheumatoid Arthritis
The purpose of this study is to determine whether baricitinib therapy alone is noninferior to methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid arthritis (RA) in those who have had limited…
- Trial name
- RA-BEGIN (NCT01711359)
- Testing
- Baricitinib, Methotrexate, Folic Acid
- Where
- 154 sites in United States, Argentina and 17 more
- Volunteers
- 588 people
- Sponsor
- Eli Lilly and Company
Gastric Ulcer, Duodenal Ulcer
Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID
The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily…
- Conditions
- Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis
- Trial name
- NCT00542789
- Testing
- Esomeprazole
- Where
- 39 sites in Japan
- Volunteers
- 343 people
- Sponsor
- AstraZeneca
ECG, Pharmacokinetics
Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML
This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory…
- Conditions
- ECG, Pharmacokinetics, Safety
- Trial name
- NCT03727750
- Testing
- Gemtuzumab Ozogamicin
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 51 people
- Sponsor
- Pfizer
Mucopolysaccharidosis Type 7
An Open-Label Phase 1/2 Study to Assess the Safety, Efficacy and Dose of Study Drug UX003 Recombinant Human Beta-glucuronidase (rhGUS) Enzyme Replacement Therapy in Patients With Mucopolysaccharidosis Type 7 (MPS 7)
UX003-CL201 is an open-label Phase 1/2 study to assess the safety, efficacy, and dose of UX003 in MPS 7 patients via intravenous (IV) administration every other week (QOW) for 36 weeks with up to an additional 36 weeks from the…
- Trial name
- NCT01856218
- Testing
- UX003
- Where
- United Kingdom
- Volunteers
- 3 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Diabetes
Harnessing Health IT for Self-Management Support and Medication Activation in a Medicaid Health Plan
To measure the effects of a Medical health plan-directed automated telephone self-management support system (ATSM) on patient outcomes among ethnically diverse health plan enrollees with diabetes.
- Trial name
- SMARTSteps (NCT00683020)
- Testing
- ATSM Intervention
- Where
- United States
- Volunteers
- 362 people
- Sponsor
- University of California, San Francisco