Clinical trials: Oral Manifestations
Schizophrenia, Bipolar Disorder
Aripiprazole Open-Label, Safety and Tolerability Study
The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.
- Trial name
- APEX 241 (NCT00102518)
- Testing
- Aripiprazole
- Where
- 50 sites in United States
- Volunteers
- 325 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Infectious Diseases
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such…
- Trial name
- NCT00761462
- Testing
- Ciprofloxacin, Non-quinolone antibiotic
- Where
- 67 sites in United States, Canada
- Volunteers
- 1,029 people
- Sponsor
- Bayer
Epilepsy, Seizures
A Study of Intravenous Perampanel in Japanese Participants With Epilepsy
The purpose of the study is to evaluate the safety and tolerability of perampanel administered as a 30-minute intravenous infusion after switching from oral tablets (8 to 12 milligrams per day [mg/day]) as an adjunctive therapy…
- Trial name
- NCT03754582
- Testing
- Perampanel
- Where
- 13 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Eisai Co., Ltd.
Postoperative Pain, Acute Pain
Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pain
To find out if a drug called tapentadol administered by mouth safely relieves pain in children. Look at the amount of tapentadol in the blood after a single oral dose.
- Trial name
- NCT01729728
- Testing
- Tapentadol
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- Grünenthal GmbH
Mucositis, Graft-versus-host Disease
Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX
A comparative trial where all patients will receive daily doses of tacrolimus (TAC) until day +60 when tapering will begin, in the absence of graft-versus-host disease (GVHD), and discontinued by day +180.
- Trial name
- NCT00360685
- Testing
- Tac+MTX, TAC + MMF
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Dravet Syndrome
A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome
The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of ZX008 (fenfluramine hydrochloride) when added to adjunctive antiepileptic stiripentol treatment in children and young adults with Dravet…
- Trial name
- NCT02926898
- Testing
- ZX008 (Fenfluramine Hydrochloride)
- Where
- 28 sites in United States, Canada and 5 more
- Volunteers
- 87 people
- Sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Cerebral Palsy, Neurological Conditions
Safety and Efficacy Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Conditions
This is an open-label clinical research study of an oral glycopyrrolate liquid for the treatment of chronic moderate to severe drooling in patients with cerebral palsy or other neurological conditions.
- Conditions
- Cerebral Palsy, Neurological Conditions, Mental Retardation, Sialorrhea
- Trial name
- NCT00491894
- Testing
- Oral Glycopyrrolate Liquid
- Where
- 7 sites in United States
- Volunteers
- 137 people
- Sponsor
- Shionogi
Epilepsy, Generalized Tonic-clonic Seizures
An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures
The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with Levetiracetam by the investigators and who are willing to continuously receive this drug.
- Trial name
- NCT01398956
- Testing
- Levetiracetam
- Where
- 32 sites in Japan
- Volunteers
- 44 people
- Sponsor
- UCB Pharma
Cytomegalovirus Infection
Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss
This is an international, multi-center, double-blind, placebo-controlled evaluation valganciclovir treatment for up to 54 children (up to 4 years of age) with virologically-confirmed congenital CMV infection and hearing loss.
- Trial name
- NCT01649869
- Testing
- Valganciclovir
- Where
- 18 sites in United States, United Kingdom
- Volunteers
- 54 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Focal Segmental Glomerulosclerosis, Steroid Resistant Nephrotic Syndrome
Oral Galactose in Children With Steroid Resistant Nephrotic Syndrome
Focal Segmental Glomerulosclerosis (FSGS) is a devastating kidney disease which is difficult to treat and carries a poor prognosis, with 50% of affected children progressing to end stage renal disease (ESRD).
- Trial name
- NCT01113385
- Testing
- D-Galactose
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Children's National Research Institute
Prader-Willi Syndrome
Cannabidiol Oral Solution for the Treatment of Patients With Prader-Willi Syndrome
The primary objective of this study is to assess the efficacy of cannabidiol oral solution on hyperphagia-related behavior in patients with Prader-Willi Syndrome (PWS).
- Trial name
- NCT02844933
- Testing
- Cannabidiol
- Where
- 7 sites in United States
- Volunteers
- 7 people
- Sponsor
- Radius Pharmaceuticals, Inc.
Rhinitis
Safety Study of Levocetirizine Oral Solution for Japanese Pediatrics
To evaluate the safety of treatment with levocetirizine oral solution in pediatric patients aged form 6 months to 2 years old with allergic rhinitis or pruritus associated with the skin diseases.
- Trial name
- NCT01563081
- Testing
- Levocetirizine
- Where
- 7 sites in Japan
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
Acute Pain
A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain
The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product…
- Trial name
- NCT02081391
- Testing
- Tapentadol oral solution 4 mg/mL, Tapentadol oral solution 20 mg/mL
- Where
- 43 sites in United States, Bulgaria and 8 more
- Volunteers
- 216 people
- Sponsor
- Grünenthal GmbH
Epilepsy, Generalized Tonic-Clonic Seizures
A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)
The purpose of this study is to evaluate the efficacy, safety and tolerability of levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients aged ≥16 years and with uncontrolled Generalized…
- Trial name
- NCT01228747
- Testing
- Levetiracetam
- Where
- 58 sites in China, Japan
- Volunteers
- 361 people
- Sponsor
- UCB Japan Co. Ltd.
Venous Thromboembolism
EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis
The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. Safety will be assessed by looking at the incidence and types of bleeding events.
- Trial name
- EINSTEINJr (NCT02309411)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 29 sites in United States, Australia and 13 more
- Volunteers
- 46 people
- Sponsor
- Bayer
Seizures Associated With EMAS
Efficacy and Safety of GWP42003-P Oral Solution in Children With Epilepsy With Myoclonic-atonic Seizures
The primary aim of Part A of the study to assess the efficacy and tolerability of GWP42003-P compared to placebo as an adjunctive treatment for children with Epilepsy with myoclonic-atonic seizures (EMAS) -associated seizures.
- Trial name
- NCT05288283
- Testing
- GWP42003-P
- Where
- 14 sites in United States, Italy
- Volunteers
- 3 people
- Sponsor
- Jazz Pharmaceuticals
Dysmenorrhea
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval.
- Trial name
- NCT00196313
- Testing
- levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
- Where
- 13 sites in United States
- Volunteers
- 95 people
- Sponsor
- Duramed Research
Seizures
Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders
This is a Phase 1/2, open-label trial designed to assess the pharmacokinetics, safety, tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral Solution in a sequential fashion.
- Trial name
- NCT02324673
- Testing
- Cannabidiol Oral Solution
- Where
- 10 sites in United States
- Volunteers
- 61 people
- Sponsor
- INSYS Therapeutics Inc
Tourette's Disorder, Tic Disorder
Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
The goal of the current trial is to determine efficacy and safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.
- Trial name
- NCT01727700
- Testing
- Aripiprazole
- Where
- 75 sites in United States, Canada and 7 more
- Volunteers
- 133 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Immune Thrombocytopenia
Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)
This was a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of <30,000/μL (and no single platelet count >35,000/μL) on two counts at least 5 days apart in…
- Trial name
- LUNA 3 (NCT04562766)
- Testing
- Rilzabrutinib
- Where
- 155 sites in United States, Argentina and 24 more
- Volunteers
- 232 people
- Sponsor
- Principia Biopharma, a Sanofi Company