Clinical trials: Withdrawal
Juvenile Idiopathic Arthritis
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to…
- Trial name
- NCT01230827
- Testing
- CNTO 148 (Golimumab), Methotrexate
- Where
- 35 sites in United States, Austria and 10 more
- Volunteers
- 173 people
- Sponsor
- Janssen Research & Development, LLC
Prader-Willi Syndrome
Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome
This is a single-center, open-label, single-arm study with a double-blind, placebo-controlled, randomized withdrawal extension. Patients are initiated on a DCCR dose of about 1.5 mg/kg (maximum starting dose of 145 mg) and are…
- Trial name
- NCT02034071
- Testing
- DCCR
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Essentialis, Inc.
Gastroesophageal Reflux Disease (GERD)
Phase 3/Safety & Efficacy of Esomeprazole in Infants
The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD).
- Trial name
- NCT00468559
- Testing
- Open Label Run In Esomeprazole, Double Blind Esomeprazole
- Where
- 25 sites in United States, France and 2 more
- Volunteers
- 98 people
- Sponsor
- AstraZeneca
Neonatal Opioid Withdrawal Syndrome
CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome
- Trial name
- NOWSHINE (NCT04104646)
- Testing
- CHF6563, Morphine
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Neurostimulation to Improve NOWS Outcomes
The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
- Trial name
- SPROUT (NCT05129020)
- Testing
- Sparrow Fledging Therapy System
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- Spark Biomedical, Inc.
Pain, Pain, Acute
Assessing Opioid Care Practices Using CPV Patient Simulation Modules
This study will test the quality of opioid-related physician care decisions using a patient-simulation based measurement and feedback approach that combines multiple-choice care decisions with real-time, personalized scoring and…
- Conditions
- Pain, Pain, Acute, Pain, Chronic, Pain, Neuropathic
- Trial name
- NCT04080037
- Testing
- Quality IQ Patient Simulations
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Qure Healthcare, LLC
Non-24-Hour Sleep-Wake Disorder
Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder
The purpose of this study is to evaluate the maintenance effect and safety of 20 mg tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder.
- Trial name
- NCT01430754
- Testing
- tasimelteon
- Where
- 22 sites in United States
- Volunteers
- 20 people
- Sponsor
- Vanda Pharmaceuticals
Wilson Disease
Study to Assess Long-Term Outcomes of Trientine in Wilson Disease Patients Withdrawn From Therapy With d-Penicillamine
A study to review Wilson disease patients who have previously been prescribed d- Penicillamine but were changed to trientine as treatment for their disease, and to follow them for a further 12 months.
- Trial name
- NCT02426905
- Testing
- trientine dihydrochloride
- Where
- 4 sites in Germany, Greece and 2 more
- Volunteers
- 90 people
- Sponsor
- Univar BV
Hypertension
Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure
The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months…
- Trial name
- NCT00435162
- Testing
- Valsartan 0.25 mg/kg, Valsartan 1.0 mg/kg, Valsartan 4.0 mg/kg
- Where
- 11 sites in United States, Belgium and 9 more
- Volunteers
- 74 people
- Sponsor
- Novartis Pharmaceuticals
Attention Deficit Hyperactivity Disorder
Efficacy & Safety of KAPVAY™ Extended-Release in Children & Adolescents With Attention Deficit Hyperactivity Disorder
The purpose of this study is to determine the long-term efficacy and safety of KAPVAY™ (clonidine hydrochloride) extended-release in children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD)
- Trial name
- NCT01439126
- Testing
- clonidine hydrochloride
- Volunteers
- 135 people
- Sponsor
- Concordia Pharmaceuticals Inc., Barbados
Autistic Disorder, Autism
Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder…
- Conditions
- Autistic Disorder, Autism, Asperger's Disorder, Asperger Syndrome
- Trial name
- NCT01592747
- Testing
- Memantine Hydrochloride (HCl)
- Where
- 94 sites in United States, Belgium and 13 more
- Volunteers
- 479 people
- Sponsor
- Forest Laboratories
Opioid Withdrawal (Disorder), Opioid Use Disorder
A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects
The goal of this clinical study is to evaluate the pharmacokinetic (PK), safety, and tolerability of LUCEMYRA in adolescents age ≥12 to <18 years old abruptly discontinuing opioid use.
- Trial name
- NCT06711640
- Testing
- LUCEMYRA (lofexidine) tablets
- Where
- United States
- Sponsor
- USWM, LLC (dba US WorldMeds)
Juvenile Psoriatic Arthritis
A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis
The purpose of this study is to evaluate the drug levels, efficacy, and safety of Deucravacitinib (BMS-986165) in pediatric participants with juvenile psoriatic arthritis.
- Trial name
- NCT06869551
- Testing
- Deucravacitinib
- Where
- 48 sites in United States, Brazil and 9 more
- Volunteers
- 60 people
- Sponsor
- Bristol-Myers Squibb
Kidney Failure, Graft vs Host Disease
A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients
This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue…
- Trial name
- NCT00195429
- Testing
- Tacrolimus, Sirolimus, prednisone
- Where
- Brazil
- Volunteers
- 47 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hypertension
Treatment of Pediatric Hypertension With Altace Trial
Ramipril is an ACE inhibitor that has been marketed in the US for the treatment of hypertension since 1991. It has been shown to be effective in reducing both systolic and diastolic blood pressure in adults when used once daily.
- Trial name
- NCT00044265
- Testing
- ramipril
- Where
- 30 sites in United States
- Volunteers
- 310 people
- Sponsor
- Pfizer
Hyponatremia
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
The purpose of this trial was to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent participants with euvolemic or hypervolemic hyponatremia.
- Trial name
- NCT02012959
- Testing
- Tolvaptan
- Where
- 7 sites in United States, Italy and 1 more
- Volunteers
- 9 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Diabetes Mellitus, Type 1
Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients
The study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter trial in subjects with Type 1 diabetes (T1D) followed by a 2-year safety follow-up.
- Trial name
- SUNRISE (NCT03895437)
- Testing
- TOL-3021
- Where
- 23 sites in United States
- Volunteers
- 78 people
- Sponsor
- Tolerion, Inc.
Cystic Fibrosis
A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)
This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme.
- Trial name
- NCT00434278
- Testing
- Dornase alfa
- Where
- 40 sites in United States
- Volunteers
- 27 people
- Sponsor
- Genentech, Inc.
Monocarboxylate Transporter 8 Deficiency, Allan-Herndon-Dudley Syndrome
Withdrawal of Tiratricol Treatment in Males With Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency)
This is a double-blind, randomized phase 3 multicenter placebo-controlled study in at least 16 evaluable male participants diagnosed with MCT8 deficiency.
- Trial name
- ReTRIACt (NCT05579327)
- Testing
- Tiratricol
- Where
- 8 sites in United States, Netherlands and 1 more
- Volunteers
- 20 people
- Sponsor
- Rare Thyroid Therapeutics International AB
Renal Transplant
Study Evaluating Rapamune® Maintenance Regimen
Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients. Secondary : 1.
- Trial name
- NCT00478608
- Testing
- Sirolimus (Rapamune®)
- Where
- 9 sites in South Korea
- Volunteers
- 79 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer