Clinical trials: Adverse Effect
Carcinoid Syndrome
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week…
- Trial name
- NCT01677910
- Testing
- Telotristat etiprate
- Where
- 75 sites in United States, Australia and 10 more
- Volunteers
- 135 people
- Sponsor
- Lexicon Pharmaceuticals
Schizophrenia, Bipolar Disorder
A Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children
The purpose of this study is to evaluate the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children, and the risk of prolactin-related adverse events…
- Conditions
- Schizophrenia, Bipolar Disorder, Autistic Disorder, Conduct and Other Disruptive Behavior Disorders
- Trial name
- NCT01050582
- Testing
- Risperidone, Other atypical antipsychotic drugs
- Where
- 28 sites in United States, Belgium and 4 more
- Volunteers
- 244 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3
The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with…
- Trial name
- GAUSS-3 (NCT01984424)
- Testing
- Atorvastatin, Ezetimibe
- Where
- 58 sites in United States, Australia and 11 more
- Volunteers
- 511 people
- Sponsor
- Amgen
Ototoxicity
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing…
- Trial name
- NCT02819856
- Testing
- SPI-1005 Ebselen 200mg Capsule x1, SPI-1005 Ebselen 200mg Capsule x2, SPI-1005 Ebselen 200mg Capsule x3
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Sound Pharmaceuticals, Incorporated
Smallpox Vaccine Adverse Reaction
VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV
The purpose of this study is to vaccinate plasma donors with ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).
- Trial name
- NCT01158157
- Testing
- ACAM2000
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use
Food and Insulin Effect on QT/QTC Interval of ECG
Moxifloxacin is routinely used as a probe to confirm assay sensitivity in thorough electrocardiogram (ECG) studies. It has been shown that a meal shortens the QT interval, which may affect pharmacokinetics (PK) and/or…
- Conditions
- Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use, C-Peptide Effects on the QT/QTc Interval, Moxifloxacin ECG Profile in Fed and Fasted State
- Trial name
- C11035 (NCT01642485)
- Testing
- Moxifloxacin 400 mg fasted, FDA breakfast, Continental breakfast
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Richmond Pharmacology Limited
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.
Hyperphosphatemia
Long-term Effect of Lanthanum Carbonate on Bone
Patients enrolled in a previous study (SPD405-309), who were exposed to lanthanum carbonate (Fosrenol), were eligible to continue on any prescribed treatment for hyperphosphatemia, including lanthanum carbonate (Fosrenol), for an…
- Trial name
- NCT00557323
- Testing
- Lanthanum carbonate
- Where
- 19 sites in United States, Germany and 1 more
- Volunteers
- 34 people
- Sponsor
- Shire
Prostate Cancer
Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy
The purpose of the study is to determine the safety and clinical benefit of the combinations of abiraterone acetate and prednisone or abiraterone and dexamethasone in prostate cancer patients.
- Trial name
- NCT01867710
- Testing
- Abiraterone Acetate, Prednisone 5 mg twice daily, Prednisone 5 mg once daily
- Where
- 17 sites in Belgium, Germany and 2 more
- Volunteers
- 164 people
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
Pain, Osteoarthritis, Hip
Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee
This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who are suffering from pain due to osteoarthritis of the hip or the knee…
- Conditions
- Pain, Osteoarthritis, Hip, Osteoarthritis, Knee
- Trial name
- NCT00980798
- Testing
- OROS hydromorphone HCl
- Where
- 12 sites in Czechia, Romania and 2 more
- Volunteers
- 288 people
- Sponsor
- Janssen-Cilag International NV
Small Cell Lung Cancer, Soft Tissue Sarcoma
Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells.
- Conditions
- Small Cell Lung Cancer, Soft Tissue Sarcoma, Triple-negative Breast Cancer, Ovarian Cancer
- Trial name
- EDO-S101 (NCT03345485)
- Testing
- Tinostamustine 60mg/m2 over 30min, Tinostamustine 80mg/m2 over 30min, Tinostamustine 100mg/m2 over 30min
- Where
- 13 sites in United States, Canada and 3 more
- Volunteers
- 71 people
- Sponsor
- Mundipharma Research Limited
Physician Education
A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes?
Randomized trial to evaluate impact of healthcare provider( clinician and nursing staff) support and education on treatment discontinuation rates in the absence of progression in patients with metastatic colorectal cancer treated…
- Trial name
- SMART (NCT02287025)
- Testing
- Regorafenib (Stivarga, BAY73-4506), iPAD application, Bayer specialist
- Where
- 17 sites in United States
- Volunteers
- 23 people
- Sponsor
- Bayer
Cardiovascular Disease, High Cardiovascular Risk
A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in overweight and obese subjects with cardiovascular (CV) disease and/or multiple CV risk factors.
- Conditions
- Cardiovascular Disease, High Cardiovascular Risk, Obesity, Overweight
- Trial name
- CAMELLIA-TIMI (NCT02019264)
- Testing
- Lorcaserin hydrochloride
- Where
- 499 sites in United States, Australia and 6 more
- Volunteers
- 14,673 people
- Sponsor
- Eisai Inc.
Carcinoid Syndrome
Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO
The primary objective of the study is to estimate the proportion of carcinoid syndrome (CS) patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO).
- Trial name
- RELAX (NCT03223428)
- Testing
- Xermelo
- Where
- United States
- Volunteers
- 223 people
- Sponsor
- TerSera Therapeutics LLC
Dry Eye Disease
Research Study To See How Well An Eye Drop (SURF-200) Works, What Side Effects There Are, And To Compare It With Vehicle In Subjects With An Episodic Flare-Up of Dry Eye Disease
SURF-200 is being studied in people experiencing an episodic flare-up of their dry eye disease. SURF-200 is an investigational drug (which means the study drug is currently being tested) in the form of a sterile eye drop.
- Trial name
- NCT04734210
- Testing
- 0.02% Betamethasone Sodium Phosphate, 0.04% Betamethasone Sodium Phosphate
- Where
- 28 sites in United States
- Volunteers
- 139 people
- Sponsor
- Surface Ophthalmics, Inc.
Ventilator Adverse Event, Ventilator Associated Pneumonia
Effect of Angulus on Patient-elevation Compliance
Ventilator-associated events (VAE) are a scourge of critical care settings and hospital systems at large. There is extensive evidence that ventilator-associated pneumonia (VAP) and related VAEs increase mortality rates in…
- Conditions
- Ventilator Adverse Event, Ventilator Associated Pneumonia, Hospital Acquired Condition, Hospital-acquired Pneumonia
- Trial name
- NCT03496220
- Testing
- Angulus
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Angulus, LLC
Carcinoid Syndrome
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy
The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide…
- Trial name
- NCT00853047
- Testing
- Telotristat etiprate, Octreotide LAR Depot
- Where
- 9 sites in United States
- Volunteers
- 23 people
- Sponsor
- Lexicon Pharmaceuticals
Acromegaly, Neuroendocrine Tumors
Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)
This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid…
- Trial name
- NCT02299089
- Testing
- octreotide FluidCrystal® injection depot
- Where
- 10 sites in France, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Camurus AB
Forehead Lines
A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants With Forehead Lines
Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin.
- Trial name
- NCT05152576
- Testing
- OnabotulinumtoxinA X
- Where
- 8 sites in United States
- Volunteers
- 124 people
- Sponsor
- Allergan
Hypercholesterolemia, Atherosclerosis
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)
The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.
- Conditions
- Hypercholesterolemia, Atherosclerosis, Statin Adverse Reaction
- Trial name
- NCT03001076
- Testing
- Bempedoic acid, Ezetimibe
- Where
- United States
- Volunteers
- 269 people
- Sponsor
- Esperion Therapeutics, Inc.