Clinical trials: Safety Study
Exocrine Pancreatic Insufficiency
Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)
Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis.
- Trial name
- NCT02598128
- Testing
- RELiZORB
- Where
- 11 sites in United States
- Volunteers
- 34 people
- Sponsor
- Alcresta Therapeutics, Inc.
Clostridium Infections
Safety and Immunogenicity Study of GSK's Clostridium Difficile Vaccine 2904545A When Administered in Healthy Adults Aged 18-45 Years and 50-70 Years
The purpose of this study is to generate safety, reactogenicity (assessment of any expected or unexpected side effect of the vaccine) and immunogenicity (ability to induce an immune response) data for the development of a…
- Trial name
- NCT04026009
- Testing
- C. difficile investigational vaccine based on the F2 antigen (GSK2904545A), C. difficile investigational vaccine based on the F2 antigen (GSK2904545A) adjuvanted with AS01B
- Where
- Belgium
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Spinal and Bulbar Muscular Atrophy
Safety, Tolerability, and Efficacy of BVS857 in Patients With Spinal and Bulbar Muscular Atrophy
The purpose of this study was to determine if BVS857 is safe, tolerable and increases thigh muscle thickness in patients with spinal bulbar and muscular atrophy (SBMA).
- Trial name
- NCT02024932
- Testing
- BVS857
- Where
- 6 sites in United States, Denmark and 2 more
- Volunteers
- 37 people
- Sponsor
- Novartis Pharmaceuticals
Influenza
Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu)
This was a Phase 1/2, randomized, observer-blinded, active-controlled trial to assess the Safety and Tolerability of a Recombinant Trivalent Nanoparticle Influenza Vaccine (Tri-NIV) with Matrix M1™ Adjuvant in Healthy Older…
- Trial name
- NCT03293498
- Testing
- NanoFlu, Fluzone HD - Day 0, Fluzone HD - Day 21
- Where
- 3 sites in United States
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Novavax
Tuberculosis, HIV Infections
Safety and Immunogenicity of AERAS-402 in HIV-infected, Bacillus Calmette-Guerin (BCG)-Vaccinated Adults
This was a Phase II, randomized, double-blind, placebo-controlled trial conducted at 1 site in South Africa. A total of 26 subjects were randomized 1:1 to receive 2 doses of either AERAS-402 at 3 x 10^10 vp (N=13) or placebo…
- Trial name
- NCT01017536
- Testing
- AERAS-402
- Where
- South Africa
- Volunteers
- 26 people
- Sponsor
- Aeras
Chronic Hepatitis C
Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care
The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24…
- Trial name
- NCT01359644
- Testing
- PSI-7977, Daclatasvir, Ribavirin
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 350 people
- Sponsor
- Bristol-Myers Squibb
Pulmonary Disease, Chronic Obstructive
A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC)…
- Trial name
- NCT01822899
- Testing
- Umeclidinium bromide/Vilanterol, Fluticasone propionate/Salmeterol
- Where
- 78 sites in Czechia, Denmark and 6 more
- Volunteers
- 717 people
- Sponsor
- GlaxoSmithKline
Rett Syndrome, RTT
Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome
To evaluate the efficacy of cannabidiol oral solution (GWP42003-P, CBD-OS) in reducing symptom severity when compared with placebo, in participants with Rett syndrome.
- Trial name
- ARCH (NCT03848832)
- Testing
- GWP42003-P
- Where
- 26 sites in United States, Italy and 2 more
- Volunteers
- 29 people
- Sponsor
- Jazz Pharmaceuticals
Obesity, Overweight
A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)
This is a study of tirzepatide in Chinese participants without Type 2 Diabetes who have obesity or overweight. The main purpose is to learn more about how tirzepatide affects body weight.
- Conditions
- Obesity, Overweight, Metabolism and Nutrition Disorder
- Trial name
- SURMOUNT-CN (NCT05024032)
- Testing
- Tirzepatide
- Where
- 29 sites in China
- Volunteers
- 210 people
- Sponsor
- Eli Lilly and Company
Back Pain, Low Back Pain
Tapentadol Prolonged Release (PR) Versus Oxycodone/Naloxone Prolonged Release in Severe Chronic Low Back Pain With a Neuropathic Component.
This was a clinical effectiveness trial designed to compare the effectiveness, safety, and tolerability of treatment with tapentadol prolonged release with that of oxycodone/naloxone prolonged release in non-opioid pre-treated…
- Conditions
- Back Pain, Low Back Pain, Neuropathic Pain
- Trial name
- NCT01838616
- Testing
- Tapentadol Prolonged Release, Oxycodone/Naloxone Prolonged Release
- Where
- 50 sites in Austria, Germany and 2 more
- Volunteers
- 367 people
- Sponsor
- Grünenthal GmbH
Coronavirus Disease 2019 COVID-19
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19)
This is a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety and efficacy of TJ003234 administered as an intravenous (IV) infusion in subjects with severe COVID-19 under supportive care, and…
- Trial name
- NCT04341116
- Testing
- TJ003234
- Where
- 14 sites in United States
- Volunteers
- 149 people
- Sponsor
- I-Mab Biopharma US Limited
Evaluation of a Rotavirus Vaccine
Phase I/II Descending Age Study of P2VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers and Infants
This is is a study of a parenteral rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study will examine the safety and immunogenicity of this vaccine first in healthy South African toddlers.
- Trial name
- NCT02109484
- Testing
- P2-VP8 Subunit Vaccine 10mcg, P2-VP8 Subunit Vaccine 30 mcg, P2-VP8 Subunit Vaccine 60mcg
- Where
- South Africa
- Volunteers
- 204 people, healthy volunteers welcome
- Sponsor
- PATH
Differentiated Thyroid Cancer (DTC)
Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer
The purpose of this study is to assess the efficacy and safety of dabrafenib in combination with trametinib for treating adult patients with locally advanced or metastatic Differentiated Thyroid Cancer (DTC) harboring the…
- Trial name
- NCT04940052
- Testing
- Dabrafenib, Trametinib
- Where
- 41 sites in United States, Argentina and 9 more
- Volunteers
- 153 people
- Sponsor
- Novartis Pharmaceuticals
COVID-19
Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older
The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a…
- Trial name
- VAT00008 (NCT04904549)
- Testing
- SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent D614) (primary series), SARS-CoV-2 adjuvanted recombinant protein vaccine (bivalent D614 + B.1.351) (primary series), SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination
- Where
- 86 sites in United States, Colombia and 9 more
- Volunteers
- 23,670 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Acquired Bleeding Disorder, Trauma
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding
This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and…
- Trial name
- CONTROL (NCT00184548)
- Testing
- eptacog alfa (activated)
- Where
- 14 sites in United States, Brazil and 12 more
- Volunteers
- 554 people
- Sponsor
- Novo Nordisk A/S
Anesthesia
Dose-Finding Pediatric and Adult Trial With Sugammadex (Org 25969, MK-8616, SCH 900616) (19.4.306) (MK-8616-034) (P05961)
The purpose of this study is: to explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616) given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult participants…
- Trial name
- NCT00421148
- Testing
- Sugammadex 0.5 mg/kg, Sugammadex 1 mg/kg, Sugammadex 2 mg/kg
- Volunteers
- 94 people
- Sponsor
- Merck Sharp & Dohme LLC
Acne Vulgaris
A Efficacy and Safety of Duac™Compared With Clindamycin Phosphate Gel in the Treatment of Mild to Moderate Acne Vulgaris
This is a multicentre, randomized, assessor-blind, comparator-controlled evaluation of the efficacy, safety, and tolerability of Duac™Once Daily Gel and clindamycin phosphate gel in the topical treatment of mild to moderate…
- Trial name
- NCT01915732
- Testing
- Duac™Once Daily Gel, 1% clindamycin phosphate gel
- Where
- 24 sites in China
- Volunteers
- 1,018 people
- Sponsor
- GlaxoSmithKline
Papulopustular Rosacea
Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea
Rosacea is a common chronic inflammatory relapsing-remitting skin condition almost exclusively affecting the central area of the face and the eyes.
- Trial name
- NCT05150587
- Testing
- Rifaximin
- Where
- 38 sites in United States
- Volunteers
- 216 people
- Sponsor
- Alfasigma S.p.A.
Skin and Subcutaneous Tissue Bacterial Infections, Gram-Positive Bacterial Infections
TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
The purpose of this study is to evaluate safety, tolerability, pharmacokinetic characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens.
- Trial name
- P2_ABSSSI (NCT03964493)
- Testing
- TNP-2092, Vancomycin
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- TenNor Therapeutics Limited
Acute, Uncomplicated Human Influenza
A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza
The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.
- Trial name
- NCT00705406
- Testing
- Peramivir
- Where
- 123 sites in United States, Australia and 2 more
- Volunteers
- 405 people
- Sponsor
- BioCryst Pharmaceuticals