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Last Updated: November 26, 2020

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CLINICAL TRIALS PROFILE FOR CHILDREN'S ADVIL-FLAVORED

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505(b)(2) Clinical Trials for Children's Advil-flavored

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00000773 Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To determine the safety, tolerance, and pharmacokinetics of a new improved microparticulate suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94 amendment, a third dose level was added) daily for 12 days in HIV-infected and perinatally exposed (per 8/9/95 amendment) infants and children who are at risk of developing Pneumocystis carinii pneumonia (PCP). Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has been prepared as a microparticulate suspension. Since studies in adults have demonstrated substantial safety of this drug, evaluation in children is being pursued.
New Formulation NCT00001736 New Cysteamine Eye Drops Formulation to Treat Corneal Crystals in Cystinosis Completed National Eye Institute (NEI) Phase 1 1998-05-01 This study will evaluate the safety and effectiveness of a new formulation of eye drops used to treat cystine crystals that form in the corneas of patients with cystinosis. Cystinosis is an inherited disease caused by a defective enzyme, in which excessive amounts of the amino acid cystine accumulate in the body. Among others, symptoms include poor growth and development of kidney failure. In addition, after 10 to 20 years, the cornea-the outside covering of the eye over the iris and pupils-becomes so packed with cystine crystals that small, painful breaks may develop. This corneal condition is treated with cysteamine eye drops. This study is designed to provide additional information about this medication that the Food and Drug Administration requires before approving it for marketing. The study will examine, in two separate but simultaneous investigations, the safety and effectiveness of a new cysteamine formulation. In both studies, before treatment begins, patients will have a complete eye examination, and photographs of the eye will be taken using a bright flash. Safety Study Children and adults currently enrolled in a cystinosis study at the National Institutes of Health may participate in this trial. They will receive the current cysteamine formulation in one eye and the new preparation in the other eye. The drops will be given every hour during waking hours. Patients will be observed daily for the first week of treatment and will be called at 2 weeks and 4 weeks to check on side effects, if any. At 6 months, they will undergo a repeat eye examination. Patients (or their parents) will keep a daily diary recording the condition of each eye. Effectiveness Study Children and adults from Ann Arbor, Michigan, LaJolla, California, and the NEI clinic may be enrolled in this study. Participants will receive medication as described above for the safety trial. They will be observed daily for the first week and will have repeat eye examinations, including photographs, at months 3, 6, 9 and 12 to see if the crystals have decreased. Patients will keep a daily diary of the condition of both eyes.
New Formulation NCT00054756 Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients With Thyroid or Pituitary Abnormalities Suspended National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2003-02-01 This study will determine the safety and activity of a new formulation of thyrotropin-releasing hormone (TRH), a drug used for diagnosing and evaluating patients with certain thyroid gland abnormalities. Normal thyroid gland function depends on proper chemical signaling between the thyroid gland, the hypothalamus (the part of the brain where TRH is made), and the pituitary (another part of the brain). The TRH test helps assess this interaction. Production of the only FDA-approved preparation of TRH was stopped in July 2002. As a result, to have a continuous source of TRH available for NIH clinical and research purposes, the NIH Clinical Center (CC) Pharmacy Department produced a pharmaceutical grade formulation of TRH for patient use. This study will test the CC formulation in healthy volunteers to show that its activity and side effects are similar to those of the previously available commercial test preparation. It will then be studied in CC patients for whom the diagnostic test is recommended. Healthy volunteers between 18 and 65 years of age and all patients requiring TRH evaluation of hypothalamic-pituitary-thyroid gland interaction may be eligible for this study. Patients include those with pituitary reserve, inconsistent thyroid function test, inappropriate TSH secretion, or pre- and post-operative evaluation of pituitary tumors. Normal volunteers will be screened with a medical history, physical examination, and blood tests. Women of child-bearing potential will be given a pregnancy test; pregnant and breast-feeding women may not participate. The TRH test procedure will be the same for healthy volunteers and patients. All participants fast from midnight before the morning of the test. In the morning, a catheter (flexible plastic tube) is inserted into an arm vein for easy injection of the TRH and collection of blood samples. Blood pressure is monitored before and during the test. A blood sample is drawn, and then TRH is given through the catheter over a 1-minute period. Another nine blood samples are collected over a 3-hour period from the time of the TRH injection for measuring levels of various hormones. A total of less than 4 tablespoons of blood is taken for the test.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Children's Advil-flavored

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000102 Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets Completed National Center for Research Resources (NCRR) Phase 1/Phase 2 1969-12-31 This study will test the ability of extended release nifedipine (Procardia XL), a blood pressure medication, to permit a decrease in the dose of glucocorticoid medication children take to treat congenital adrenal hyperplasia (CAH).
NCT00000115 Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema Completed National Eye Institute (NEI) Phase 2 1990-12-01 To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema.
NCT00000170 Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia Completed National Eye Institute (NEI) Phase 3 1999-04-01 - To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy - To develop more precise estimates of the success rates of amblyopia treatment - To identify factors that may be associated with successful treatment of amblyopia - To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available Extended Follow up of Study Patients - Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years. - Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Children's Advil-flavored

Condition Name

Condition Name for Children's Advil-flavored
Intervention Trials
Asthma 243
HIV Infections 178
Malaria 161
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Condition MeSH

Condition MeSH for Children's Advil-flavored
Intervention Trials
Leukemia 375
Disease 357
Syndrome 309
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Clinical Trial Locations for Children's Advil-flavored

Trials by Country

Trials by Country for Children's Advil-flavored
Location Trials
France 552
Germany 534
United Kingdom 527
Australia 482
Italy 459
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Trials by US State

Trials by US State for Children's Advil-flavored
Location Trials
New York 945
Ohio 879
Pennsylvania 850
Florida 714
Massachusetts 687
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Clinical Trial Progress for Children's Advil-flavored

Clinical Trial Phase

Clinical Trial Phase for Children's Advil-flavored
Clinical Trial Phase Trials
Phase 4 1464
Phase 3 1742
Phase 2/Phase 3 303
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Clinical Trial Status

Clinical Trial Status for Children's Advil-flavored
Clinical Trial Phase Trials
Completed 3556
Recruiting 1580
Not yet recruiting 1142
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Clinical Trial Sponsors for Children's Advil-flavored

Sponsor Name

Sponsor Name for Children's Advil-flavored
Sponsor Trials
National Cancer Institute (NCI) 437
National Institute of Allergy and Infectious Diseases (NIAID) 205
M.D. Anderson Cancer Center 194
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Sponsor Type

Sponsor Type for Children's Advil-flavored
Sponsor Trials
Other 9150
Industry 2739
NIH 1289
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