A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin FlexPro in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period
Rationale: The aim of the project is to develop a long-acting once-weekly GH product which is a safe and efficacious but has greater convenience and thus potentially better compliance compared to standard once daily GH treatment.
Intervention: Subjects will receive subcutaneous injection of study drug ( NNC0195-0092, Norditropin FlexPro or placebo. ) and being monitored efficacy and safety with AE, MRI, DEXA scan, Vital signs, Hts and weights, Hematology, Biochemistry, thyroid function, Hormones ,ECG and Eye exams.
Objectives or purpose: The primary objective is to access the efficacy and the secondary objective is to evaluate the clinical safety.
Study population or sample characteristics: This study is aiming for subjects who is between age of 23-79 with diagnosis of GHD who has no history of or active malignant disease.
Study methodology: Two hundred and eighty will be randomized in a 2:2:1 (NNC0195-0092: Norditropin FlexPro: placebo) ratio. The trial will compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily dosing of Norditropin FlexPro in adults with GHDs during the 35-week period (8 week dose titration, 26 week fixed dose treatment followed by 1 week washout), with a 53-week extension period (8 week dose titration, 44 week fixed dose treatment followed by 1 week washout). After the main trial period placebo subjects will be switched to NNC0195-0092 treatment and Norditropin FlexPro subjects will be randomised 1:1 to NNC0195-0092 or Norditropin FlexPro.
Study endpoints or outcomes: The primary endpoint will be at week 34 for the main trial and the secondary endpoint will be at 86 weeks for the extension period of trial. The study is looking for the outcome of changing in truncal fat mass and truncal lean body mass after the treatment, as well as to evaluate the safety of this drug.
Follow-up: Follow up visit will be scheduled 2 weeks after last treatment.
Statistics and plans for analysis: For each of the complete data sets, the change from baseline to 34 weeks is analysed using an ANCOVA model with treatment, GHD onset type, sex, region, DM and sex by region by DMinteraction as factors and the baseline truncal fat value as a covariate. From the pooled estimates, the treatment difference at Week 34 between NNC0195-0092 and placebo willbe estimated and the corresponding 95% CI and p-value will be calculated.Superiority of NNC0195-0092 over placebo will be considered confirmed if the upper boundary of
the two-sided 95% CI of the treatment difference (NNC0195-0092 placebo) is below 0. Sensitivity analysis will also be completed. Two partial database locks are planned during the trial.
A Phase 3, Randomized, Double Blind, Placebo And Active‑Controlled, Multicenter, Parallel‑Group Study Of The Analgesic Efficacy And Safety Of Tanezumab In Adult Subjects With Chronic Low Back Pain
This is a randomized, double blind, placebo and active controlled, multicenter, parallel
group Phase 3 study of the efficacy and safety of tanezumab when administered by SC
injection for up to 56 weeks in subjects with chronic low back pain. Approximately 1800
subjects will be randomized to 1 of 4 treatment groups in a 2:2:2:3 ratio (ie, 400 subjects
per treatment group for the placebo, tanezumab 5 mg and tanezumab 10 mg treatment groups and
600 subjects in the tramadol PR treatment group). Treatment groups will include: 1.) Placebo
administered SC at an 8 week interval plus placebo matching tramadol PR up to Week 16. At
the Week 16 visit, subjects in this group who meet the efficacy responder criteria will be
switched in a blinded fashion in a 1:1 ratio to either tanezumab 5 mg or tanezumab 10 mg
administered SC at an 8 week interval plus placebo matching tramadol PR to Week 56;
2.)Tanezumab 5 mg SC administered at an 8 week interval plus placebo matching tramadol PR to
Week 56; 3.) Tanezumab 10 mg SC administered at an 8 week interval plus placebo matching
tramadol PR to Week 56; 4.) Oral tramadol PR plus placebo administered SC at an 8 week
interval to Week 56. The study is designed with a total duration (post randomization) of up
to 80 weeks and will consist of three periods: Screening (up to a maximum of 37 days;
includes a Washout Period and an Initial Pain Assessment Period), a Double blind Treatment
Period (comprised of a 16 week Primary Efficacy Phase and a 40 week Long Term Safety and
Efficacy Phase), and a Follow up Period (24 weeks). The Screening Period (beginning up to 37
days prior to Randomization) includes a Washout Period (lasting 2 32 days), if required, and
an Initial Pain Assessment Period (the 5 days prior to Randomization/Baseline). Prior to
entering the study, subjects must have a documented history of previous inadequate treatment
response to medications in 3 different categories of agents commonly used to treat and
generally considered effective for the treatment of chronic low back pain.
Inspire Upper Airway Stimulation Post-FDA Approval Study
The purpose of this study is to obtain additional long-term safety and efficacy data on the use of the Inspire Upper Airway Stimulation System to treat obstructive sleep apnea.
Assessing the safety and efficacy of Macitentan in patients with portopulmonary hypertension
Several drugs (blood vessel dilators), including macitentan, are currently approved for the treatment of pulmonary arterial hypertension (PAH) in many parts of the world. These drugs have significantly improved the outcome of the condition. However, none of these treatments have been evaluated in portopulmonary hypertension, a form of PAH caused by liver disease. The purpose of this study is to assess the safety and effectiveness of macitentan in portopulmonary hypertension by looking at several clinical indicators, including the pressures within the arteries of the lungs and a person’s capacity for exercise.
Recruiting | High Blood Pressure / Hypertension | Not Multisite
A Placebo-controlled Study of a Targeted Immune Therapy Drug in Subjects with Moderate to Severe Ulcerative Colitis (UC)
The primary objective of this study is to study the effectiveness of a novel targeted immune therapy (biologic) called LY3074828 in treating moderate to severe ulcerative colitis. This study will take place over 120 weeks and all study visits and procedures will be provided at no cost to you. During the initial part of this study, patients will either receive LY3074828, or placebo ("dummy" treatment). Patients who receive placebo initially will have the opportunity to receive the study drug LY3074828 later in the study.
Investigating efficacy and safety of adjunctive therapy in Parkinson’s Disease patients
Parkinson’s Disease involves the loss of brain cells that produce dopamine, a messenger that sends information to the parts of the brain that control movement and coordination. Lower than normal levels of dopamine in the brain causes the symptoms of Parkinson’s, including muscle stiffness, resting tremor (uncontrollable shaking), and slowing of movements. Parkinson’s patients may have “on” periods where they are able to control their muscle movement, and “off” times when controlling these movements is harder.
Levodopa is a medication used to help treat Parkinson’s by increasing dopamine levels in the brain. We are looking for participants who have these “on” and “off” periods, and who are on Levodopa and at least one other medication. We are looking at whether adding tozadenant, a drug that hasn’t been approved by the U.S. FDA, will help improve Parkinson’s symptoms.
Recruiting | parkinsons adjunctive therapy | Not Multisite
ENRICH: A Multi-center, Randomized, Clinical Trial Comparing Standard Medical Management to Early Surgical Hematoma Evacuation Using Minimally Invasive Parafascicular Surgery (MIPS) in the Treatment of Intracerebral Hemorrhage (ICH).
The ENRICH trial will compare the outcomes between early surgical intervention using the
BrainPath® Approach (i.e., MIPS) and a medically managed cohort. The integrated surgical
approach includes a combination of available technologies, including the FDA-cleared NICO
BrainPath® for non-disruptive access and NICO Myriad® to achieve the goal of maximum clot
evacuation. The medically managed cohort will be treated according the Clinical
Standardization Guidelines (CSG) as adapted by Emory University from the 2015 AHA/ASA
Guidelines for the Management of Spontaneous Intracerebral Hemorrhage. Clinical efficacy
will be determined by demonstrating a 10% improvement in functional outcome, as determined
by a blinded-assessment of the 180-day utility-weighted modified Rankin Scale (mRS).
Data suggests improved mortality rates and potential functional benefits of surgical ICH
evacuation. The methodology proposed for this trial was tested in a preliminary series of 39
patients treated for supratentorial spontaneous ICH and retrospectively reviewed (Labib et
al.). These results were replicated in a single center retrospective series of 18 patients
(Bauer et al.). Despite positive results of both studies and the widely accepted benefit of
the BrainPath Approach (i.e., MIPS) for subcortical lesions, stronger evidence supporting
the use of these techniques in ICH is needed for the technique to become universally
validated.
Recruiting | Subcortical Intracerebral Hemorrhage | Site Unknown
Spectroscopic detection of colon polyps (Spy Colonic Neoplasia)
The purpose of this study is to determine if colon cancer or precancerous colon polyps can be predicted from examining the lining of the rectum with a special harmless light. If so, primary care physicians will be able to determine from this simple test which of their patients actually needs a colonoscopy instead of referring 100% of their patients simply because they turn 50 years old.
Healthy Minds Volunteer Database
The Healthy Minds Volunteers (http://healthyminds.usc.edu) help research labs at the University of Southern California. These labs are working towards a greater understanding of how aging can affect physical, mental and emotional health. The goal is to learn how we can maintain healthy minds and bodies across our lifespan.
Assessing brain response to sugar
This study is aimed at understanding brain and hunger responses to different types of sugars and how this influences feeding behavior in lean and obese people.
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