Clinical trials: Medication Safety
Actinic Keratosis
To Compare Safety and Efficacy of Perrigo's Drug Compared to an FDA Approved Drug in the Treatment of Actinic Keratosis
The purpose of this study is to compare safety and efficacy of Perrigo's drug compared to an FDA approved drug in the treatment of actinic keratosis.
- Trial name
- NCT02459795
- Testing
- Ingenol Mebutate (Perrigo), Ingenol Mebutate (Reference)
- Volunteers
- 469 people
- Sponsor
- Padagis LLC
Tuberculosis, Pulmonary, Tuberculosis, MDR
Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis
The purpose of this study is to assess the efficacy and safety of 2 repurposed drugs (acetylsalicylic acid and ibuprofen), for use as adjunct therapy added to, and compared with, the standard of care (SoC) WHO-recommended TB…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, MDR, Tuberculosis Infection
- Trial name
- SMA-TB (NCT04575519)
- Testing
- Control group, ASA group, IBU group
- Where
- 3 sites in Georgia, South Africa
- Volunteers
- 426 people
- Sponsor
- Fundació Institut Germans Trias i Pujol
HIV Infections
Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand
The primary goals of this study are to assess the safety and efficacy of daily tenofovir to prevent parenteral HIV infection among injection drug users (IDUs).
- Trial name
- NCT00119106
- Testing
- Tenofovir disoproxil
- Where
- Thailand
- Volunteers
- 2,413 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Open Angle Glaucoma
MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
The study will evaluate the efficacy and safety of the implant and intra-ocular pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery.
- Trial name
- STAR-I (NCT03193736)
- Testing
- MINIject implant
- Where
- 2 sites in India, Panama
- Volunteers
- 26 people
- Sponsor
- iSTAR Medical
Idiopathic Thrombocytopenic Purpura
Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.
The purpose of this study is to investigate the efficacy, safety and tolerability of eltrombopag in children with previously treated chronic immune thrombocytopenia who are between 1 and 17 years of age. This is a 2 part study.
- Trial name
- PETIT2 (NCT01520909)
- Testing
- Eltrombopag
- Where
- 51 sites in United States, Argentina and 11 more
- Volunteers
- 92 people
- Sponsor
- GlaxoSmithKline
Narcolepsy Type 1
A Study of TAK-861 in People With Narcolepsy Type 1
The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment.
- Trial name
- NCT06505031
- Testing
- TAK-861
- Where
- 28 sites in Australia, Austria and 9 more
- Volunteers
- 105 people
- Sponsor
- Takeda
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
Crohn's Disease
Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease
This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in…
- Trial name
- NCT02038920
- Testing
- Vedolizumab
- Where
- 56 sites in Japan
- Volunteers
- 157 people
- Sponsor
- Takeda
Hypertension
Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension
Single-center, single group study of the efficacy and safety of transcatheter renal denervation for treatment of patients with essential hypertension uncontrolled despite combined pharmacotherapy including 3 or more hypotensive…
- Trial name
- NCT01499810
- Testing
- Bilateral radiofrequency sympathetic renal denervation
- Where
- Russia
- Volunteers
- 53 people
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
Type 2 Diabetes Mellitus
A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)
The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A in comparison to a commonly used medication in patients with type 2 diabetes.
- Trial name
- NCT00541450
- Testing
- Comparator: sitagliptin phosphate (sitagliptin), sitagliptin phosphate (+) metformin hydrochloride, Comparator: pioglitazone
- Volunteers
- 492 people
- Sponsor
- Merck Sharp & Dohme LLC
Kidney Transplantation
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based…
- Trial name
- NCT00282568
- Testing
- Tacrolimus Modified Release (MR), tacrolimus
- Where
- 9 sites in United States, Canada
- Volunteers
- 70 people
- Sponsor
- Astellas Pharma Inc
Carcinoid Syndrome, Carcinoid
Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome.
- Conditions
- Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum
- Trial name
- NCT05361668
- Testing
- Randomized: 40 mg Paltusotine, Randomized: 80 mg Paltusotine
- Where
- 35 sites in United States, Argentina and 5 more
- Volunteers
- 36 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
HIV Infections
Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection
The purpose of this study is to determine the safety and effectiveness of an anti-HIV drug regimen followed by treatment interruption in people recently infected with HIV.
- Trial name
- NCT00414518
- Testing
- Tenofovir disoproxil fumarate/Emtricitabine, Lopinavir/Ritonavir
- Where
- 3 sites in United States, Zimbabwe
- Volunteers
- 16 people
- Sponsor
- University of Colorado, Denver
Diabetes Mellitus, Type 2
Pharmacokinetics, Pharmacodynamics, and Safety of Alogliptin in Children, Adolescents and Adults With Type 2 Diabetes Mellitus
The purpose of this study is to determine the pharmacokinetic and safety profile of alogliptin in children, adolescents, and adults with type 2 diabetes mellitus.
- Trial name
- NCT00957268
- Testing
- Alogliptin
- Where
- 7 sites in United States
- Volunteers
- 46 people
- Sponsor
- Takeda
Rheumatoid Arthritis
A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent
This open-label study will evaluate the efficacy and safety of tocilizumab as monotherapy or in combination with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) in participants with active…
- Trial name
- ACT-MOVE (NCT02046603)
- Testing
- Tocilizumab, DMARDs, Oral Corticosteroids
- Where
- 38 sites in United Kingdom
- Volunteers
- 162 people
- Sponsor
- Hoffmann-La Roche
Involutional Osteoporosis
A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets
The present phase II/III, multicenter, randomized, double-blind, parallel group comparative study is designed to evaluate the efficacy and safety of once-monthly oral administration of NE-58095 delayed release (DR) tablets for 12…
- Trial name
- NCT02063854
- Testing
- NE-58095 IR, NE-58095 DR
- Where
- 25 sites in Japan
- Volunteers
- 871 people
- Sponsor
- Takeda
Type 2 Diabetes Mellitus
A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005)
This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in participants with type 2 diabetes mellitus.
- Trial name
- NCT02004886
- Testing
- MK-0893, Metformin
- Volunteers
- 74 people
- Sponsor
- Merck Sharp & Dohme LLC
Relapsed/Refractory, Multiple Myeloma
A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM)
The purpose of this study is to assess the safety and tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-079 monotherapy and when combined with a backbone regimen of pomalidomide and dexamethasone…
- Trial name
- NCT03439280
- Testing
- Mezagitamab, Pomalidomide, Dexamethasone
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Bioavailability
Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants
The purpose of this study is to assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of dexlansoprazole delayed-release orally disintegrating (OD) tablets administered on the tongue and swallowed without water.
- Trial name
- NCT02064907
- Testing
- Dexlansoprazole Delayed Release Orally Disintegrating Tablets, Dexlansoprazole Delayed Release Capsules
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Takeda
Ulcerative Colitis, Crohn's Disease
An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease
The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
- Trial name
- GEMINI LTS (NCT00790933)
- Testing
- Vedolizumab
- Where
- 41 sites in United States, Australia and 8 more
- Volunteers
- 2,243 people
- Sponsor
- Takeda
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