Clinical trials: Patient Safety
Cough
GSK2339345 Hypertussive Challenge Study
This study is designed to evaluate the effect of GSK2339345 relative to placebo on the number of coughs in patients with Chronic Idiopathic Cough (CIC) administered by an Aqueous Droplet Inhaler (ADI).
- Trial name
- NCT01899768
- Testing
- GSK2339345
- Where
- 2 sites in United Kingdom
- Volunteers
- 16 people
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus
Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin
Primary Objective: To demonstrate the superiority of Sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control with metformin.
- Trial name
- NCT02926950
- Testing
- Sotagliflozin (SAR439954), Metformin
- Where
- 93 sites in United States, Canada and 2 more
- Volunteers
- 518 people
- Sponsor
- Lexicon Pharmaceuticals
Macular Edema, Diabetes Mellitus
A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.
- Trial name
- NCT01673191
- Testing
- Dexamethasone intravitreal implant, Steroid plus NSAID eye drop combination therapy
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Retinal Consultants of Arizona
Severe Hypertriglyceridemia
Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment
The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients With Fasting High Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal Impairment.
- Trial name
- NCT03011450
- Testing
- K-877, Fenofibrate
- Where
- 241 sites in United States, Belarus and 7 more
- Volunteers
- 471 people
- Sponsor
- Kowa Research Institute, Inc.
Alzheimer's Disease
Safety Study of TRx0237 in Patients Already Taking Medications for Mild and Moderate Alzheimer's Disease
The primary purpose of this study is to assess the safety and tolerability of TRx0237 when taken at the same time as acetylcholinesterase inhibitors (i.e., donepezil, galantamine, or rivastigmine) and / or memantine to treat…
- Trial name
- NCT01626391
- Testing
- TRx0237
- Where
- 12 sites in Germany, United Kingdom
- Volunteers
- 9 people
- Sponsor
- TauRx Therapeutics Ltd
Cerebral Edema, Brain Metastases
Glyburide vs Placebo as Prophylaxis Against Cerebral Edema in Patients Receiving Radiosurgery for Brain Metastases (RAD 1502/UAB 1593)
Primary Objectives: Pilot Portion: To determine the feasibility and safety of administering oral glyburide to non-diabetic patients receiving stereotactic radiosurgery (SRS) for newly diagnosed brain metastases.
- Trial name
- NCT02460874
- Testing
- Glyburide
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Alabama at Birmingham
Rheumatoid Arthritis
Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study
To continue to assess the clinical safety and efficacy of Certolizumab Pegol as add-on therapy with stable-dose Disease Modifying Anti-Rheumatic Drugs (DMARDs)
- Trial name
- CERTAIN 2 (NCT00843778)
- Testing
- Certolizumab Pegol
- Where
- 25 sites in Austria, France and 3 more
- Volunteers
- 131 people
- Sponsor
- UCB Pharma
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
The primary objectives of this study are to assess the safety and efficacy of MS1819-SD vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
- Trial name
- OPTION (NCT03746483)
- Testing
- MS1819, Porcine PERT
- Where
- 14 sites in United States, Poland
- Volunteers
- 41 people
- Sponsor
- Entero Therapeutics
Hypertension
Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg
This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.
- Trial name
- NCT00529451
- Testing
- Aliskiren, Ramipril
- Where
- 3 sites in China, India and 1 more
- Volunteers
- 1,613 people
- Sponsor
- Novartis
Diabetes Mellitus, Type 2
Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old
The primary objective of this study is to determine if there will be a greater mean reduction from baseline in glycated hemoglobin (HbA1c) achieved after 26 weeks of oral double-blind add-on therapy of dapagliflozin or…
- Trial name
- NCT03199053
- Testing
- Dapagliflozin, Saxagliptin
- Where
- 122 sites in United States, Argentina and 21 more
- Volunteers
- 256 people
- Sponsor
- AstraZeneca
Chronic Idiopathic Urticaria
A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the safety and efficacy of omalizumab administered subcutaneously as an add-on therapy for the treatment…
- Trial name
- NCT01264939
- Testing
- Omalizumab, H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist, Diphenhydramine
- Where
- 73 sites in United States, Australia and 6 more
- Volunteers
- 336 people
- Sponsor
- Genentech, Inc.
Asthma
Evaluation of Safety and Tolerability of BI 894416 in Patients With Mild Asthma
In both parts, the primary comparisons of interest are between the percentage of patients with drug-related adverse events at each dose and placebo during single and multiple dosing regimens.
- Trial name
- NCT03971539
- Testing
- BI 894416
- Where
- Germany
- Volunteers
- 68 people
- Sponsor
- Boehringer Ingelheim
Mucopolysaccharidosis I, Hurler's Syndrome
A Dose-optimization Study of Aldurazyme® (Laronidase) in Patients With Mucopolysaccharidosis I (MPS I) Disease
The main purpose of this study is to evaluate differences in the pharmacodynamic response of 4 Aldurazyme® (laronidase) dose regimens in patients with Mucopolysaccharidosis I (MPS I).
- Conditions
- Mucopolysaccharidosis I, Hurler's Syndrome, Hurler-Scheie Syndrome, Scheie Syndrome
- Trial name
- NCT00144781
- Testing
- Aldurazyme (Recombinant Human Alpha-L-Iduronidase)
- Where
- 5 sites in Brazil, Canada
- Volunteers
- 34 people
- Sponsor
- Genzyme, a Sanofi Company
Rheumatoid Arthritis
A Study of the Safety and Efficacy of Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Methotrexate
This was a Phase II, randomized, double-blind, multicenter study designed to evaluate the safety and efficacy of rituximab, administered at two different regimens for 2 years, in patients with moderate to severe active rheumatoid…
- Trial name
- RUMBA (NCT00243412)
- Testing
- folate, methotrexate, methylprednisolone
- Volunteers
- 42 people
- Sponsor
- Genentech, Inc.
Diabetes Mellitus, Type 2
Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes
The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients…
- Trial name
- NCT01159600
- Testing
- BI 10773
- Where
- 148 sites in United States, Canada and 10 more
- Volunteers
- 1,504 people
- Sponsor
- Boehringer Ingelheim
Stomach Neoplasms
An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy
The study consisted of two parts. In Part 1 the study enrolled 38 patients (Step 1 Simon 2 step design) after which Step 2 was opened and the total enrollment target for the study (n=63) was exceeded due to a rapid enrollment (78…
- Trial name
- NCT00226811
- Testing
- Sunitinib
- Where
- 18 sites in China, Hong Kong and 5 more
- Volunteers
- 78 people
- Sponsor
- Pfizer
Nocturia
Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients
The purpose of this trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose…
- Trial name
- NCT01262456
- Testing
- Desmopressin
- Where
- 56 sites in United States, Canada
- Volunteers
- 395 people
- Sponsor
- Ferring Pharmaceuticals
Peripheral T Cell Lymphoma, Transformed Mycosis Fungoides
Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma.
- Trial name
- REDIRECT (NCT04101331)
- Testing
- AFM13
- Where
- 69 sites in United States, Australia and 8 more
- Volunteers
- 108 people
- Sponsor
- Affimed GmbH
Osteoarthritis of the Knee or Hip
Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip
The primary objective of the study is to describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed OA of the knee or hip.
- Trial name
- FACT LTS & OA (NCT02683239)
- Testing
- Fasinumab
- Where
- 149 sites in United States, Bulgaria and 19 more
- Volunteers
- 5,331 people
- Sponsor
- Regeneron Pharmaceuticals
Melanoma
A Study of Safety and Clinical Activity of Immunotherapy Plus Chemotherapy in Metastatic Melanoma Patients
The purpose of this clinical trial is to find out how successfully, patients with progressive metastatic cutaneous melanoma, are able to develop an immune response to injections with the immunotherapeutic product GSK1572932A when…
- Trial name
- NCT00849875
- Testing
- Immunotherapeutic GSK2132231A, Dacarbazine
- Where
- 14 sites in Belgium, France
- Volunteers
- 48 people
- Sponsor
- GlaxoSmithKline
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