Clinical trials: Medication Safety
HIV Infections
Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)
The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients.
- Trial name
- NCT00144170
- Testing
- Tipranavir (with low dose ritonavir), Comparator protease inhibitor(CPI)/low dose ritonavir(r)
- Where
- 174 sites in Argentina, Austria and 15 more
- Volunteers
- 882 people
- Sponsor
- Boehringer Ingelheim
Constipation
Lubiprostone for Chronic Idiopathic Constipation Treatment
The purpose of this study is to evaluate the efficacy and safety of oral administration of 24 ug of lubiprostone twice daily (BID) for 4 weeks in participants with chronic idiopathic constipation (CIC) compared with placebo.
- Trial name
- NCT02729909
- Testing
- Lubiprostone
- Where
- 10 sites in Mexico
- Volunteers
- 211 people
- Sponsor
- Takeda
Viral Respiratory Tract Infection
Safety and Tolerability of Single and Multiple Doses of Neumifil
This is a Phase 1, single-centre, randomised, placebo-controlled first in human study in healthy subjects. The study will assess the safety and tolerability of single-ascending (Part A) and multiple-ascending (Part B) doses of…
- Trial name
- NCT05093530
- Testing
- Neumifil
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pneumagen Ltd.
Healthy Volunteers
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4)
The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.
- Trial name
- NCT01758432
- Testing
- PRT064445/Apixaban
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Urinary Bladder, Overactive
A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug
Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults.
- Trial name
- LION (NCT01565707)
- Testing
- Solifenacin Succinate Suspension, Urotherapy
- Where
- 46 sites in United States, Belgium and 14 more
- Volunteers
- 189 people
- Sponsor
- Astellas Pharma Europe B.V.
Rheumatoid Arthritis
A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products
The objective of the current study is to assess the immunogenicity and safety of transitioning subjects with RA to DRL_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab.
- Trial name
- RI-01-007 (NCT04268771)
- Testing
- Experimental: Arm A: DRL_RI, Arm B: Rituxan®/Mabthera®
- Where
- 26 sites in United States
- Volunteers
- 140 people
- Sponsor
- Dr. Reddy's Laboratories Limited
COVID-19
A Study to Learn About a Repeat 5-Day Treatment With the Study Medicines (Called Nirmatrelvir/Ritonavir) in People 12 Years Old or Older With Return of COVID-19 Symptoms and SARS-CoV-2 Positivity After Finishing Treatment With Nirmatrelvir/Ritonavir
The purpose of this study is to learn about the safety and effects of nirmatrelvir/ritonavir for the potential treatment of COVID-19 rebound.
- Trial name
- NCT05567952
- Testing
- nirmatrelvir, ritonavir
- Where
- 84 sites in United States, Canada and 3 more
- Volunteers
- 436 people
- Sponsor
- Pfizer
Rheumatoid Arthritis
A Study to Investigate Safety, Tolerability, and PK of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis
The study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of multiple orally administered TCK-276 in both males and females with Rheumatoid Arthritis (RA).
- Trial name
- NCT05437419
- Testing
- TCK-276
- Where
- 8 sites in United States
- Volunteers
- 32 people
- Sponsor
- Teijin America, Inc.
Diabetic Macular Edema
Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema
The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release OXU-001 (dexamethasone microspheres; DEXAspheres®) using the Oxulumis®…
- Trial name
- OXEYE (NCT05697809)
- Testing
- OXU-001, Semi-automated suprachoroidal illuminated microcatheter, Ozurdex® Ophthalmic Intravitreal Implant
- Where
- 9 sites in United States, Puerto Rico
- Volunteers
- 3 people
- Sponsor
- Oxular Limited
Hidradenitis Suppurativa
Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa
The main purpose of this study is to assess preliminary efficacy and safety of CFZ533/iscalimab (Cohort A), LYS006 (Cohort B), MAS825 (Cohort C), LOU064/remibrutinib (Cohort D) and VAY736/ianalumab (Cohort E) in patients with…
- Trial name
- NCT03827798
- Testing
- CFZ533, LYS006, MAS825
- Where
- 36 sites in United States, Austria and 9 more
- Volunteers
- 248 people
- Sponsor
- Novartis Pharmaceuticals
Neoplasms, Lymphoma
A Study of TAK-981 in People With Advanced Solid Tumors or Cancers in the Immune System
This study is in 2 parts. The main aims of the 1st part of the study are to check if people with advanced solid tumors or cancers in the immune system (lymphomas) have side effects from TAK-981, and to check how much TAK-981 they…
- Conditions
- Neoplasms, Lymphoma, Hematologic Neoplasms
- Trial name
- NCT03648372
- Testing
- TAK-981
- Where
- 8 sites in United States
- Volunteers
- 109 people
- Sponsor
- Takeda
Overactive Bladder
An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).
This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in participants with OAB for up to 52 weeks.
- Trial name
- Empowur (NCT03583372)
- Testing
- Vibegron, Tolterodine Tartrate ER
- Where
- 107 sites in United States
- Volunteers
- 506 people
- Sponsor
- Urovant Sciences GmbH
Sanfilippo Syndrome, Mucopolysaccharidosis (MPS)
An Extension Study to Determine Safety and Efficacy for Pediatric Patients With MPS Type IIIA Disease Who Participated in Study HGT-SAN-093.
This extension study will allow participants to continue receiving treatment with HGT-1410 and to initiate treatment in patients who received no-treatment in Study HGT-SAN-093, and will evaluate the long-term safety and efficacy…
- Trial name
- NCT02350816
- Testing
- HGT-1410
- Where
- 8 sites in United States, France and 5 more
- Volunteers
- 17 people
- Sponsor
- Shire
Spasticity
MEDITOXIN® Versus BOTOX® in the Treatment of Post-stroke Spasticity of the Upper Limb Spasticity
This study is a randomized, double blind, multi-center, active drug controlled, phase III clinical trial to compare the efficacy and safety of MEDITOXIN® versus BOTOX® in treatment of post stroke upper limb(wrist, finger, thumb)…
- Trial name
- NCT01313767
- Testing
- Botulinum toxin type A
- Where
- South Korea
- Volunteers
- 196 people
- Sponsor
- Medy-Tox
Healthy Volunteers
Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the pharmacokinetics (PK), safety and immunogenicity profile of MB02 with US and EU Avastin® in healthy male subjects.
- Trial name
- NCT04238663
- Testing
- MB02 (Bevacizumab Biosimilar), EU approved Avastin®, US licenced Avastin®
- Where
- Germany
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- mAbxience Research S.L.
Infertility
Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)
The study to compare to the efficacy and safety of Crinone versus combination medication in infertile women receive frozen-thawed embryo transfer (FET) in artificial cycles (AC).
- Trial name
- NCT03858049
- Testing
- Crinone, Duphaston
- Where
- China
- Volunteers
- 172 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection
A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)
The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection.
- Conditions
- Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection, Chronic Hepatitis C, Compensated Cirrhosis and Non-cirrhotics
- Trial name
- EXPEDITION-2 (NCT02738138)
- Testing
- ABT-493 coformulated with ABT-530
- Volunteers
- 153 people
- Sponsor
- AbbVie
Acne Vulgaris
A Study of a New Drug Treatment for Acne
A study to determine if three different doses of a new acne treatment are safe and better at reducing facial acne than a treatment without active ingredient.
- Trial name
- NCT01326780
- Testing
- 1.2% JNJ 10229570-AAA, 2.4% JNJ 10229570-AAA, 3.6% JNJ 10229570-AAA
- Where
- 18 sites in United States
- Volunteers
- 431 people
- Sponsor
- Bausch Health Americas, Inc.
Lupus Nephritis
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of Ixazomib in Lupus Nephritis (LN)
The purpose of this study is to characterize the safety and tolerability of ixazomib when administered as multiple oral doses at escalating dose levels in participants with lupus nephritis.
- Trial name
- NCT02176486
- Testing
- Ixazomib
- Where
- 35 sites in United States, France and 5 more
- Volunteers
- 12 people
- Sponsor
- Takeda
Epilepsy
A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on…
- Trial name
- NCT02201251
- Testing
- Topiramate, Levetiracetam
- Where
- 41 sites in United States, Argentina and 12 more
- Volunteers
- 63 people
- Sponsor
- Janssen Research & Development, LLC
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