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Phase IV - Post Launch

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GDT in Urgent Abdominal Surgery - A Clinical Randomized Trial
Published:

EudraCT Number: 2015-000563-14
Sponsor Protocol Number: 2014-734
Sponsor Name: Holbæk Sygehus, Region Sjælland i Danmark
Start Date: 2015-07-22
Medical condition: Perforated intestinal diseases and obstructive bowel diseases with an urgent need for surgery.
Disease:
Version: 20.0
SOC Term: 100000023018
Classification Code: 10000663
Term: Acute anaphylactic reaction
Level: LLT
Version: 20.0
SOC Term: 100000019552
Classification Code: 10020680
Term: Hypernatremia
Level: LLT
Version: 20.0
SOC Term: 100000108096
Classification Code: 10007968
Term: Central pontine myelinolysis
Level: LLT
Version: 20.0
SOC Term: 100000028113
Classification Code: 10039910
Term: Seizures
Level: LLT

Population Age: Adults, Elderly
Gender: Male, Female
Trial Protocol: DK (Completed)

A randomised double blind, placebo controlled study of the efficacy of topical menthol for pain relief during topical photodynamic therapy.
Published:

EudraCT Number: 2015-002849-59
Sponsor Protocol Number: 2015PQ01
Sponsor Name: University of Dundee, NHS Tayside
Start Date: 2018-02-07
Medical condition: Actinic keratosis (pre-cancerous sun damage)on the face and scalp
Disease:
Version: 20.0
SOC Term: 10040785 - Skin and subcutaneous tissue disorders
Classification Code: 10000614
Term: Actinic keratosis
Level: PT
Version: 20.0
SOC Term: 10040785 - Skin and subcutaneous tissue disorders
Classification Code: 10000614
Term: Actinic keratosis
Level: PT

Population Age: Adults, Elderly
Gender: Male, Female
Trial Protocol: GB (Prematurely Ended)

A randomized, double-blind, placebo-controlled multicenter study of Secukinumab (AIN457) to examine the clinical efficacy and the NSAID-sparing effect of Secukinumab over 16 weeks in patients with ...
Published:

EudraCT Number: 2015-004575-74
Sponsor Protocol Number: CAIN457FDE03
Sponsor Name: Novartis Pharma GmbH
Start Date: 2016-03-16
Medical condition: Ankylosing Spondylitis
Disease:
Version: 20.0
SOC Term: 10028395 - Musculoskeletal and connective tissue disorders
Classification Code: 10002556
Term: Ankylosing spondylitis
Level: PT

Population Age: Adults, Elderly
Gender: Male, Female
Trial Protocol: DE (Completed)

PharmaSwiss Recalls Emerade Adrenaline Pens
Published: 5 Dec 2019 | 22:09 UTC

The UK’s Medicines and Healthcare products Regulatory Agency advised healthcare professionals to quarantine all remaining stock and return it to the supplier.

Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion
Published: 5 Dec 2019 | 17:00 UTC

Conditions:   Atrial Fibrillation;   Atrial Flutter
Interventions:   Drug: Propofol;   Drug: Methohexital
Sponsor:   Wake Forest University Health Sciences
Not yet recruiting

Inner and Middle Ear Effects of Hyperbaric Oxygen Thrapy
Published: 5 Dec 2019 | 17:00 UTC

Condition:   Otitic Barotrauma
Intervention:   Drug: Hyperbaric oxygen
Sponsor:   Assiut University
Not yet recruiting

Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation
Published: 5 Dec 2019 | 17:00 UTC

Conditions:   DENT IMPLANTS;   LASER
Interventions:   Procedure: Conventional mechanical therapy;   Drug: Saline;   Drug: Methylene Blue;   Device: Light emitting laser;   Device: Non-light emitting laser
Sponsor:   The University of Texas Health Science Center, Houston
Not yet recruiting

Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever
Published: 5 Dec 2019 | 17:00 UTC

Conditions:   Neutropenia, Febrile;   Leukemia;   Pediatric Cancer;   Antibiotic Reaction
Interventions:   Drug: Ceftazidime Injection;   Drug: Cefepime Injection
Sponsor:   Indonesia University
Completed

Zionexa Has Signed an Exclusive Agreement With PETNET Solutions Inc. for Manufacturing and Distribution
Published: 5 Dec 2019 | 0:00 UTC

Zionexa, a radiopharmaceutical company specialized in the development and commercialization of in-vivo biomarkers for use in guiding targeted therapies in oncology, and PETNET Solutions Inc., a Siemens Healthineers company specializing in the manufacturing and distribution of positron emission tomography (PET) biomarkers, have entered into an exclusive agreement for the manufacturing and distribution of Zionexa’s new PET diagnostic drug, Fluoroestradiol

RenovaCare Stockholder Update and 2020 Outlook from the CEO
Published: 5 Dec 2019 | 0:00 UTC

RenovaCare, Inc. (Symbol: RCAR), developer of patented technologies for spraying self-donated stem cells for the regeneration of skin and other organs and tissues, is pleased to provide this update from its new CEO, Mr. Alan L. Rubino, as well as his outlook for 2020.

Generex Biotechnology Announces Funding Update
Published: 5 Dec 2019 | 0:00 UTC

Generex Biotechnology Corporation (OTCQB: GNBT) is pleased to announce that the company has finalized agreements to provide significant funding for ongoing operations, launching new businesses, and advancing the commercial development of new products from the NuGenerex family of companies

Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics
Published: 3 Dec 2019 | 17:00 UTC

Conditions:   Vitamin D Deficiency;   Insulin Resistance;   Diabetes Mellitus, Type 2
Intervention:   Drug: oral vitamin D
Sponsor:   King Edward Medical University
Completed

A Phase 4 Clinical Study of Brodalumab
Published: 3 Dec 2019 | 17:00 UTC

Conditions:   Psoriasis Vulgaris;   Psoriatic Arthritis;   Pustular; Psoriasis, Palmaris Et Plantaris;   Psoriatic Erythroderma
Intervention:   Drug: Brodalumab 210mg SC
Sponsor:   Kyowa Kirin Co., Ltd.
Completed

A Phase 4 Clinical Study of Brodalumab
Published: 3 Dec 2019 | 17:00 UTC

Conditions:   Psoriasis Vulgaris;   Psoriatic Arthritis;   Pustular; Psoriasis, Palmaris Et Plantaris;   Psoriatic Erythroderma
Intervention:   Drug: Brodalumab 210mg SC
Sponsor:   Kyowa Kirin Co., Ltd.
Completed

Let’s run our trials for the real patient populations
Published: 3 Dec 2019 | 12:39 UTC

Keri McDonough, Leader for Advocacy and Patient Relations at Syneos Health shares guidance on how to enroll and retain diverse patient groups

Coloplast Pulls Ureteral Stent Kits Over ‘Packaging Anomaly’
Published: 2 Dec 2019 | 21:51 UTC

All potentially affected inventories were placed on hold.

A Study to Qualify an In-house Reference Standard Batch of Sci-B-Vac™
Published: 27 Nov 2019 | 17:00 UTC

Condition:   Hepatitis B
Intervention:   Biological: Sci-B-Vac™
Sponsor:   VBI Vaccines Inc.
Completed

The need for the patient perspective in clinical trial recruitment
Published: 26 Nov 2019 | 10:39 UTC

Christine Crandall, Head of Strategic Clinical Planning and GlaxoSmithKline offers insight on how we can solve the communication problem present in patient recruitment

TGA Flags Risks for Accu-Chek Blood Glucose Meters
Published: 20 Nov 2019 | 18:44 UTC

The errors could lead to serious medical problems for diabetic patients, the agency said.

GAO Flags How a REMS May Slow Generics
Published: 15 Nov 2019 | 22:47 UTC

Generic drugmakers have acknowledged to the GAO that their inability to access samples of reference drugs because of distribution limitations under certain risk evaluation and mitigation strategies (REMS) delayed or discouraged them from developing generic drugs.

Mallinckrodt Announces New Clinical Data Evaluating Acthar® Gel (Repository Corticotropin Injection) in Rheumatoid Arthritis (RA) at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting
Published: 12 Nov 2019 | 0:00 UTC

New analysis from Phase 4 study in RA showed that statistically significant improvement from baseline in patient-reported outcomes for pain, fatigue, physical functioning and work-related impairment was associated with Acthar Gel treatment

CNS Summit: Discussions on Virtual and Hybrid Clinical Trials
Published: 12 Nov 2019 | 0:00 UTC

Jonathan Cotliar, chief medical officer of Science 37, a leader in virtual clinical trials, took time to speak with BioSpace about virtual and hybrid clinical trials, the CNS Summit and Science 37.

How to retain 500 patients to complete 104 site visits over two years
Published: 5 Nov 2019 | 12:35 UTC

Dr. Harold Shlevin, CEO of Galectin Therapeutics, shares their strategy to engage and retain patients during clinical trials

ICER Questions Cost-Effectiveness of Novo Nordisk’s Diabetes Drug Rybelsus
Published: 1 Nov 2019 | 22:11 UTC

The Institute for Clinical and Economic Review (ICER) has questioned the cost-effectiveness of Novo Nordisk’s recently approved Type 2 diabetes treatment Rybelsus (oral semaglutide) compared to alternatives.

A CRA’s Digital Journey, aka How I Learned to Love my eTMF
Published: 30 Oct 2019 | 0:00 UTC

As a consultant CRA with more than a decade of experience, I took on the assignment of managing the essential TMF documents for two large phase 3 dermatology studies in 2007 thinking “This won’t be so bad!”

GlaxoSmithKline Loses Bid to End Zofran Lawsuits
Published: 25 Oct 2019 | 22:56 UTC

GlaxoSmithKline lost its bid to end multiple lawsuits against the company alleging that its anti-nausea drug Zofran (ondansetron) caused birth defects.

A Study of Baricitinib in Participants With Rheumatoid Arthritis
Published: 12 Sep 2019 | 16:00 UTC

Condition:   Rheumatoid Arthritis
Interventions:   Drug: Baricitinib;   Drug: TNF Inhibitor
Sponsors:   Eli Lilly and Company;   Incyte Corporation
Not yet recruiting

A Clinical Study Investigating the Efficacy of a Stannous Fluoride Dentifrice in Improving Gingival Health After Twice Daily Use for 3 Weeks
Published: 8 Aug 2019 | 16:00 UTC

Condition:   Gingivitis
Interventions:   Drug: Sensodyne Repair and Protect;   Drug: Colgate Cavity Protection
Sponsor:   GlaxoSmithKline
Completed

SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"
Published: 26 Jul 2019 | 16:00 UTC

Condition:   Atopic Dermatitis
Interventions:   Drug: DUPILUMAB;   Drug: PLACEBO
Sponsors:   Sanofi;   Regeneron Pharmaceuticals
Recruiting

Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for Multiple Sclerosis (MS)
Published: 23 May 2019 | 16:00 UTC

Condition:   Multiple Sclerosis
Intervention:   Drug: Cladribine
Sponsors:   EMD Serono Research & Development Institute, Inc.;   Merck KGaA, Darmstadt, Germany
Recruiting

Apremilast and Moderate to Severe Chronic Hand Dermatitis
Published: 15 Nov 2018 | 17:00 UTC

Condition:   Chronic Hand Dermatitis
Intervention:   Drug: Apremilast 30mg
Sponsors:   Alison Ehrlich;   Celgene Corporation
Terminated

Apremilast and Moderate to Severe Chronic Hand Dermatitis
Published: 15 Nov 2018 | 17:00 UTC

Condition:   Chronic Hand Dermatitis
Intervention:   Drug: Apremilast 30mg
Sponsors:   Alison Ehrlich;   Celgene Corporation
Terminated

Safety and Efficacy Study of Oral Fosfomycin Versus Oral Levofloxacin to Treat Complicated Urinary Syndromes (FOCUS)
Published: 5 Oct 2018 | 16:00 UTC

Condition:   Urinary Tract Infection
Interventions:   Drug: Fosfomycin tromethamine;   Drug: Levofloxacin
Sponsor:   National Institute of Allergy and Infectious Diseases (NIAID)
Terminated

Gelclair at Conditioning or After Oral Mucositis Diagnosed vs. Magic Mouth Wash in Stem Cell Transplant Recipients
Published: 6 Apr 2018 | 16:00 UTC

Condition:   Oral Mucositis
Interventions:   Device: Gelclair;   Combination Product: First® Mouthwash BLM
Sponsors:   Midatech Pharma US Inc.;   PharPoint Research, Inc.
Terminated

Gelclair at Conditioning or After Oral Mucositis Diagnosed vs. Magic Mouth Wash in Stem Cell Transplant Recipients
Published: 6 Apr 2018 | 16:00 UTC

Condition:   Oral Mucositis
Interventions:   Device: Gelclair;   Combination Product: First® Mouthwash BLM
Sponsors:   Midatech Pharma US Inc.;   PharPoint Research, Inc.
Terminated

Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects
Published: 10 Mar 2009 | 16:00 UTC

Condition:   Opioid-Induced Constipation
Interventions:   Drug: methylnaltrexone;   Drug: placebo
Sponsors:   Bausch Health Americas, Inc.;   Progenics Pharmaceuticals, Inc.
Withdrawn



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