You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 9, 2024

CLINICAL TRIALS PROFILE FOR CHILDREN'S ADVIL COLD


✉ Email this page to a colleague

« Back to Dashboard


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

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 Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2003-02-07 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.
OTC NCT00124787 ↗ A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis Completed Canadian Association of Emergency Physicians Phase 4 2005-04-01 Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
OTC NCT00124787 ↗ A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis Completed St. Justine's Hospital Phase 4 2005-04-01 Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Children's Advil Cold

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
NCT00000170 ↗ Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia Completed Jaeb Center for Health Research 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
NCT00000363 ↗ Acute Otitis Media: Adjuvant Therapy to Improve Outcome Completed National Institute on Deafness and Other Communication Disorders (NIDCD) Phase 3 1969-12-31 Acute otitis media is one of the most common diseases of childhood and is one of the major causes of hearing loss in children. Despite the availability of effective antibiotic therapy for otitis media, treatment failures, persistent effusions, and recurrences are common. This Phase III outpatient study aims to test whether adjuvant therapy (an antihistamine or a corticosteroid), in addition to antibiotic therapy, improves the acute and long-term outcomes of patients with acute otitis media. This study is targeted to recruiting 200 infants (age less than one year); patient (and parent) participation is estimated to continue for one year after enrollment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Children's Advil Cold

Condition Name

Condition Name for Children's Advil Cold
Intervention Trials
Asthma 258
Malaria 188
HIV Infections 184
Leukemia 150
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Children's Advil Cold
Intervention Trials
Leukemia 421
Syndrome 384
Disease 381
Attention Deficit Disorder with Hyperactivity 324
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Children's Advil Cold

Trials by Country

Trials by Country for Children's Advil Cold
Location Trials
France 744
Australia 735
United Kingdom 722
Germany 713
Italy 658
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Children's Advil Cold
Location Trials
Florida 918
Massachusetts 867
Illinois 824
North Carolina 780
Maryland 766
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Children's Advil Cold

Clinical Trial Phase

Clinical Trial Phase for Children's Advil Cold
Clinical Trial Phase Trials
Phase 4 1733
Phase 3 2020
Phase 2/Phase 3 396
[disabled in preview] 2521
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Children's Advil Cold
Clinical Trial Phase Trials
Completed 4997
Recruiting 1369
Not yet recruiting 781
[disabled in preview] 1408
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Children's Advil Cold

Sponsor Name

Sponsor Name for Children's Advil Cold
Sponsor Trials
National Cancer Institute (NCI) 471
National Institute of Allergy and Infectious Diseases (NIAID) 230
M.D. Anderson Cancer Center 190
[disabled in preview] 362
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Children's Advil Cold
Sponsor Trials
Other 12098
Industry 3436
NIH 1454
[disabled in preview] 154
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.