Clinical trials: Drug Safety
Type 2 Diabetes Mellitus
Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy
The purpose of this study was to evaluate the efficacy and safety of 24-week treatment with metformin hydrochloride 500 mg once daily added on to alogliptin (SYR-322) 25 mg in type 2 diabetic patients with inadequate glycemic…
- Trial name
- NCT02068443
- Testing
- Alogliptin, Metformin hydrochloride
- Where
- 27 sites in Japan
- Volunteers
- 374 people
- Sponsor
- Takeda
Central Precocious Puberty
A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants
The purpose of this study is to evaluate the long-term safety and efficacy of Enantone in the treatment of CPP in Chinese participants.
- Trial name
- NCT02993926
- Testing
- Enantone, GnRH agonist
- Where
- 6 sites in China
- Volunteers
- 108 people
- Sponsor
- Takeda
Postoperative Nausea and Vomiting (PONV)
A Study of TAK-951 to Stop Adults Getting Nausea and Vomiting After Planned Surgery
Some adults are at a higher risk of feeling sick (nausea) or being sick (vomiting) after they have surgery. In this study, these adults will have planned surgery.
- Trial name
- NCT04557189
- Testing
- TAK-951, Ondansetron
- Where
- 7 sites in United States
- Volunteers
- 89 people
- Sponsor
- Takeda
Healthy
A Study of Multiple Doses of Lasmiditan in Healthy Participants
The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood stream and how long it takes the body to get rid of it.
- Trial name
- NCT03252015
- Testing
- Probe Drug Cocktail, Lasmiditan
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
Colitis, Ulcerative
A Study to Assess Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis (UC) Korean Participants
The purpose of this study is to assess the clinical effectiveness by the clinical response at 6 weeks and the safety of vedolizumab intravenous in UC Korean participants.
- Trial name
- NCT03535649
- Where
- 15 sites in South Korea
- Volunteers
- 105 people
- Sponsor
- Takeda
Primary Pulmonary Hypertension
Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil
The primary objective of this study is to evaluate the long-term safety and tolerability of LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial Hypertension (PAH).
- Trial name
- INSPIRE (NCT03399604)
- Testing
- LIQ861 Inhaled Treprostinil
- Where
- 38 sites in United States
- Volunteers
- 121 people
- Sponsor
- Liquidia Technologies, Inc.
Diabetes Mellitus, Type 2
Comparison of Fasiglifam (TAK-875) With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 Diabetes
The purpose of this study is to evaluate the efficacy of fasiglifam (TAK-875) plus metformin compared with sitagliptin plus metformin on glycemic control over a 24-week Treatment Period.
- Trial name
- NCT01834274
- Testing
- Fasiglifam (TAK-875), Sitagliptin, Metformin
- Where
- 104 sites in United States, Argentina and 11 more
- Volunteers
- 96 people
- Sponsor
- Takeda
Hypertension
The COREG And Lisinopril Combination Therapy In Hypertensive Subjects (COSMOS) Trial
This is a randomized, double-blind, double-dummy, parallel group trial employing 15 cells of a 4x4 factorial design (no placebo)to compare the hypertensive effects in patients with Stage 1 and Stage 2 hypertension of carvedilol…
- Trial name
- NCT00347360
- Testing
- lisinopril, carvedilol controlled release formulation
- Where
- 151 sites in United States
- Volunteers
- 654 people
- Sponsor
- GlaxoSmithKline
Solid Tumor, Advanced Solid Tumor
First in Human Study of M4344 in Participants With Advanced Solid Tumors
The purpose of this study was to evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered twice-weekly (BIW), twice daily (BID) or once daily dose schedule in participants with advanced…
- Trial name
- NCT02278250
- Testing
- M4344 10 mg BIW, M4344 20 mg BIW, M4344 40 mg BIW
- Where
- 16 sites in United States, Netherlands and 2 more
- Volunteers
- 97 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Diabetes Mellitus, Type 2
A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3)
This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (an insulin taken once daily which is already available on the market) in people with type 2 diabetes.
- Trial name
- ONWARDS 3 (NCT04795531)
- Testing
- Insulin icodec, Insulin degludec
- Where
- 190 sites in United States, Argentina and 10 more
- Volunteers
- 588 people
- Sponsor
- Novo Nordisk A/S
Hand Dermatitis
A Study for a Topical Medication Versus Placebo in Patients With Hand Dermatitis
This is a double-blind, pilot study with 20 subjects to determine the tolerability and efficacy of topical AFX 5931 in the treatment of mild to moderate hand dermatitis.
- Trial name
- AFX5931 (NCT03703895)
- Testing
- Topical AFX5931
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- The Center for Clinical and Cosmetic Research
Scar Prevention, Scar Reduction
A Phase 2a Study to Evaluate the Safety and Efficacy of AZX100 in Trocar Sites of Arthroscopic Shoulder Surgery Patients
The purpose of this study was to determine the safety of AZX100 Drug Product and to determine whether it was effective in preventing or reducing scars that were made from trocars following arthroscopic shoulder surgery.
- Trial name
- NCT00811577
- Testing
- AZX100
- Where
- 5 sites in United States
- Volunteers
- 150 people
- Sponsor
- Capstone Therapeutics
Crohn's Disease
Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease
This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in…
- Trial name
- NCT02038920
- Testing
- Vedolizumab
- Where
- 56 sites in Japan
- Volunteers
- 157 people
- Sponsor
- Takeda
Pain, Cancer
Study to Compare the Safety and Tolerability of Sativex® in Patients With Cancer Related Pain
The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® and GW-2000-02.
- Trial name
- NCT00675948
- Testing
- Sativex, GW-2000-02
- Where
- United Kingdom
- Volunteers
- 43 people
- Sponsor
- Jazz Pharmaceuticals
Epilepsy
Ataluren for Nonsense Mutation in CDKL5 and Dravet Syndrome
This is a phase 2, crossover study of Ataluren for the treatment of nonsense mutation Dravet syndrome or cyclin-dependent kinase-like 5 (CDKL5) deficiency, resulting in drug-resistant epilepsy.
- Trial name
- NCT02758626
- Testing
- ataluren
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- NYU Langone Health
Inflammatory Bowel Diseases
Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib
Patients with ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD), have been shown to be at increased risk of developing certain infections, such as shingles from the Herpes Zoster (HZ) virus, as a result of their…
- Trial name
- NCT03591770
- Testing
- SHINGRIX
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Boston Medical Center
Carcinoma, Non-Small-Cell Lung
Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung Cancer
The purpose of this study is to determine whether the combination therapy of CC-486 (oral azacitidine) and pembrolizumab provides improved patient outcomes compared to pembrolizumab alone in patients with previously treated…
- Trial name
- NCT02546986
- Testing
- CC-486, Pembrolizumab
- Where
- 33 sites in United States, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Celgene
Duodenal Ulcer
Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection
The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus lansoprazole in the treatment of participants with duodenal ulcer.
- Trial name
- NCT03050359
- Testing
- TAK-438, Lansoprazole, Bismuth-Containing Quadruple Therapy
- Where
- 81 sites in China, Philippines and 2 more
- Volunteers
- 533 people
- Sponsor
- Takeda
Type 2 Diabetes Mellitus
Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea in Participants With Type 2 Diabetes in Japan
The purpose of this study was evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an Sulfonylurea taken QD or twice daily (BID) in type 2 diabetic patients with uncontrolled blood glucose.
- Trial name
- NCT01318083
- Testing
- Alogliptin and glimepiride, Glimepiride
- Volunteers
- 312 people
- Sponsor
- Takeda
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