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NCT ID: NCT03732820 Not yet recruiting - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer

Start date: October 31, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.

NCT ID: NCT03730662 Not yet recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk

SURPASS-4
Start date: November 19, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits.

NCT ID: NCT03728764 Recruiting - Preterm Infant Clinical Trials

Growth and Safety of a Two-stage Feeding System in Preterm Infants

Start date: October 10, 2018
Phase: N/A
Study type: Interventional

This study evaluates the safety and suitability of the two-stage feeding system in preterm infants.

NCT ID: NCT03725852 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

A Clinical Study to Test How Effective and Safe GLPG1205 is for Patients With Idiopathic Pulmonary Fibrosis (IPF)

PINTA
Start date: September 27, 2018
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, parallel group, placebo-controlled, multicenter, exploratory Phase II study including subjects with Idiopathic Pulmonary Fibrosis (IPF), investigating GLPG1205 of top of local standard of care (defined as receiving nintedanib, pirfenidone, or neither nintedanib or pirfenidone).

NCT ID: NCT03702777 Recruiting - Underactive Bladder Clinical Trials

A Study of ASP8302 in Participants With Underactive Bladder

Start date: October 15, 2018
Phase: Phase 2
Study type: Interventional

The study objectives of this study are to evaluate the efficacy of ASP8302 compared with placebo in participants with underactive bladder (UAB), to investigate the safety and tolerability of ASP8302 compared with placebo in participants with UAB, to investigate the pharmacokinetics of ASP8302 in participants with UAB and to support the development of the UAB - Patient Reported Outcome (PRO).

NCT ID: NCT03689374 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

SUSTAIN 11
Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin and insulin glargine in people with type 2 diabetes. Participants will either get insulin glargine and semaglutide or insulin glargine and insulin aspart - which treatment the participant get is decided by chance. Insulin glargine is taken once a day and semaglutide once a week. Insulin aspart is taken three times per day before a meal. All three medicines come in pre-filled pens for injection under the skin. The study will last for about 71 weeks. If participant's blood sugar gets under or over certain values participant will only participate in 14 weeks. The study doctor will inform the participant about this. The participant will have 15 clinic visits and 22 phone calls with the study doctor.

NCT ID: NCT03687827 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Compare the Effect of Insulin Degludec and Insulin Glargine on Blood Sugar Levels in People With Type 2 Diabetes - the SWITCH PRO Study

SWITCH PRO
Start date: October 2, 2018
Phase: Phase 4
Study type: Interventional

This study compares the effect on blood sugar levels of two medicines: insulin degludec and insulin glargine in people with type 2 diabetes. Participants will be treated with insulin degludec and insulin glargine during two different periods. Which treatment participants get first is decided by chance. Both medicines are approved for use in humans and available on the market. They can already be prescribed by participants' doctors. Participants will get pre-filled insulin pens to inject these insulins with. The study will last for about 41 weeks. Participants will visit the clinic 13 times and have 27 phone calls with the study doctor or study staff. At 12 of the clinic visits they will take blood samples. In order to evaluate the changes in participants' blood sugar level over time, participants will be asked to wear a small (35 millimetres (mm) x 5 mm) sensor on the back of participants' upper arm 3 times during the study. Each time participants must wear the sensor for 2 weeks. This sensor is called FreeStyle Libre Pro®. It has a very small tip which is 0.4 mm thick and is inserted 5 mm under participants' skin. Please note that participants will not be able to see the sensor readings while wearing it. The study doctor will show participants the readings when participants return to the clinic. Participants will be asked to fill in a diary in between visits. Participants will have contact with the study doctor or study staff each week. This is to adjust the dose of participants' study medicines and to ensure that participants are well. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

NCT ID: NCT03687268 Recruiting - Clinical trials for Opioid-Induced Constipation

Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation

Naxos
Start date: July 31, 2017
Phase: Phase 3
Study type: Interventional

Prospective, randomised, double-blind, double-dummy, placebo-controlled, parallel-group, multi-centre, phase III trial of Naloxone HCl PR Tablets (12 mg and 24 mg) administered twice daily. The trial will consist of four phases: Screening phase (Week -4 to Week -3): Confirmation phase (Week -2 to Week -1): Double-blind treatment phase Follow-up phase (Week 13-14):

NCT ID: NCT03687255 Recruiting - Clinical trials for Urinary Tract Infections

Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections

Start date: September 24, 2018
Phase: Phase 3
Study type: Interventional

Multi-center, randomized, double-blind, non-inferiority study of cefepime 2 g/AAI101 500 mg combination compared to piperacillin 4 g/tazobactam 500 mg in a population of adult patients with cUTI or AP. The study will be conducted in approximately 115 sites located in the EU, the US, Central, South America and South Africa.

NCT ID: NCT03680612 Completed - Clinical trials for Urinary Tract Infections

Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI

Start date: September 5, 2017
Phase: Phase 2
Study type: Interventional

Phase 2, randomised, double-blind, 2-cohort study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis. All study cohorts were randomised in a 2:1 ratio. Treatment duration for each cohort was 7 to 10 days. Patients were not permitted to switch to oral therapy. Cohort 1: 15 patients treated with cefepime 1 g/AAI101 500 mg intravenous (i.v.) infusion over 2 hours once every 8 hours (q8h), and 7 patients treated with cefepime 1 g i.v. infusion over 2 hours q8h. Cohort 2: 15 patients treated with cefepime 2 g/AAI101 750 mg i.v. infusion over 2 hours q8h, and 8 patients treated with cefepime 2 g i.v. infusion over 2 hours q8h.