Clinical trials: Patient Safety
COPD
Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients
The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with AZD3199 in moderate to severe COPD.
- Trial name
- GLAD (NCT00929708)
- Testing
- AZD3199, formoterol
- Where
- 38 sites in Bulgaria, Canada and 3 more
- Volunteers
- 329 people
- Sponsor
- AstraZeneca
Procedural Sedation, Endoscopy
Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy
The purpose of this study was to assess the safety and efficacy of CNS 7056 as a procedural sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.
- Trial name
- NCT00869440
- Testing
- CNS 7056, Midazolam
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- Paion UK Ltd.
Overactive Bladder, Neurogenic Detrusor Overactivity
Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years
The purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive bladder.
- Trial name
- NCT00857896
- Testing
- Fesoterodine
- Where
- 9 sites in United States
- Volunteers
- 21 people
- Sponsor
- Pfizer
Osteoarthritis, Rheumatoid Arthritis
Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients that require long-term NSAID treatment.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain, Chronic Regional Pain Syndrome
- Trial name
- NCT00984815
- Testing
- HZT-501
- Where
- 4 sites in United States
- Volunteers
- 86 people
- Sponsor
- Amgen
Chemotherapy-Induced Nausea and Vomiting
An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting
PALO-15-17 is a clinical study assessing efficacy and safety of a single dose of palonosetron 0.25 mg administered as a 30-minute IV infusion compared to palonosetron 0.25 mg administered as a 30-second IV bolus (Aloxi, an…
- Trial name
- NCT02557035
- Testing
- Palonosetron, Dexamethasone
- Where
- 76 sites in Belarus, Bosnia and Herzegovina and 7 more
- Volunteers
- 441 people
- Sponsor
- Helsinn Healthcare SA
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB
Acute Coronary Syndrome
Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Patients With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial)
The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the occurrence of death, myocardial infarction (heart…
- Trial name
- NCT00402597
- Testing
- Rivaroxaban
- Volunteers
- 3,490 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bipolar Disorder, Schizophrenia
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
- Conditions
- Bipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder
- Trial name
- NCT06041646
- Testing
- Sublingual film containing Igalmi
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- BioXcel Therapeutics Inc
Major Depressive Disorder
Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD)
The primary objective of this study are to evaluate the synergistic effect of a combination product, consisting of drug BCI-024 (buspirone) and drug BCI-049 (melatonin), in reducing symptoms of depression in patients with Major…
- Trial name
- NCT00705003
- Testing
- BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QD, BCI-024 (Buspirone)
- Where
- 9 sites in United States
- Volunteers
- 142 people
- Sponsor
- Massachusetts General Hospital
Intra-abdominal Infection, Complicated Intra-abdominal Infection
Study of Ceftolozane/Tazobactam (MK-7625A) in Combination With Metronidazole in Japanese Participants With Complicated Intra-abdominal Infection (MK-7625A-013)
This is a Phase 3, multi-site, non-randomized, open-label study evaluating the safety and efficacy of MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) plus metronidazole 500 mg for the treatment of Complicated Intra-abdominal…
- Trial name
- NCT02739997
- Testing
- MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g), metronidazole 500 mg
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Gaucher Disease
A Study of Enzyme Replacement Therapy (VPRIV) in People With Type 1 Gaucher Disease Who Were Previously Treated With Substrate Reduction Therapy
The study will provide information on outcomes in people with type 1 Gaucher disease when they are treated with velaglucarase alfa (also called VPRIV), under standard care.
- Trial name
- SWITCH (NCT04718779)
- Testing
- Digital Engagement Application (GD App), No Intervention
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Takeda
Nail Psoriasis
Comparison of Indigo Naturalis Oil Extract and Calcipotriol Solution in Treating Psoriasis
The purpose of this study is to compare the efficacy and safety of indigo naturalis oil extract and calcipotriol solution in the treatment of psoriatic nails, to show that indigo naturalis oil extract may be a good choice for…
- Trial name
- NCT01445886
- Testing
- Indigo Naturalis Extract in Oil, Calcipotriol Solution
- Where
- Taiwan
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Yin-ku Lin
Metastatic Cancer, Solid Tumor
Sym022 (Anti-LAG-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas
This is the first study to test Sym022 in humans. The primary purpose of this study is to see if Sym022 is safe and tolerable for patients with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas…
- Conditions
- Metastatic Cancer, Solid Tumor, Lymphoma
- Trial name
- NCT03489369
- Testing
- Sym022
- Where
- 3 sites in United States, Canada
- Volunteers
- 15 people
- Sponsor
- Symphogen A/S
Hepatitis B
Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B
This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B vaccine, administered as an add-on therapy to entecavir or tenofovir.
- Trial name
- NCT02496897
- Testing
- FP-02.2 Vaccine, IC31® Adjuvant
- Where
- 21 sites in South Korea, United Kingdom
- Volunteers
- 61 people
- Sponsor
- Altimmune, Inc.
Carcinoma, Non-Small-Cell Lung
Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation
Primary objective of the trial is to evaluate the safety of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR (Epidermal growth factor receptor) mutation(s) and have never…
- Trial name
- NCT01953913
- Testing
- Afatinib
- Where
- 33 sites in China, Hong Kong and 3 more
- Volunteers
- 542 people
- Sponsor
- Boehringer Ingelheim
Palmoplantar Pustulosis
A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
This study is open to people with palmoplantar pustulosis who took part in previous clinical studies of a medicine called spesolimab.
- Trial name
- NCT04493424
- Testing
- Spesolimab
- Where
- 66 sites in United States, Australia and 12 more
- Volunteers
- 108 people
- Sponsor
- Boehringer Ingelheim
Rosacea
A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea
The purpose of the study is to compare the safety and efficacy profiles of a generic Azelaic Acid Gel, 15% to the reference listed Finacea® (azelaic acid) Gel, 15% in the treatment of moderate facial rosacea.
- Trial name
- NCT02120924
- Testing
- Azelaic acid, Vehicle, Finacea
- Where
- 30 sites in United States
- Volunteers
- 1,009 people
- Sponsor
- Actavis Inc.
Hyperkalaemia, Heart Failure With Reduced Ejection Fraction
Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone
The main objective of this study is to evaluate the efficacy of SZC as compared with placebo in keeping potassium levels within the normal range (3.5-5.0 mEq/L) while on spironolactone ≥25 mg daily without assistance of rescue…
- Trial name
- REALIZE-K (NCT04676646)
- Testing
- Sodium zirconium cyclosilicate, Spironolactone
- Where
- 89 sites in United States, Brazil and 6 more
- Volunteers
- 366 people
- Sponsor
- AstraZeneca
Heart Failure
A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure
This was a multicenter, randomized, placebo- and active-controlled, parallel-group, 24-week trial to investigate the efficacy, safety, and tolerability of XXB750 in participants with HFrEF/HFmrEF.
- Trial name
- NCT06142383
- Testing
- XXB750 Low dose, XXB750 Medium Dose, XXB750 High Dose
- Where
- 62 sites in United States, Bulgaria and 10 more
- Volunteers
- 136 people
- Sponsor
- Novartis Pharmaceuticals
Arthritis, Psoriatic
A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis
The purpose of this study is to evaluate the safety and efficacy (improvement of signs and symptoms) of subcutaneous (under the skin) injections of golimumab for the treatment of active psoriatic arthritis (PsA).
- Trial name
- GO-REVEAL (NCT00265096)
- Testing
- golimumab
- Where
- 51 sites in United States, Belgium and 4 more
- Volunteers
- 407 people
- Sponsor
- Centocor, Inc.
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