| ATOVAQUONE
CHILDREN'S ADVIL
CHILDREN'S ADVIL ALLERGY SINUS
CHILDREN'S ADVIL COLD
CHILDREN'S ADVIL-FLAVORED
|
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.
|
| CHILDREN'S ADVIL
CHILDREN'S ADVIL ALLERGY SINUS
CHILDREN'S ADVIL COLD
CHILDREN'S ADVIL-FLAVORED
CYSTEAMINE HYDROCHLORIDE
|
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.
|
| ADEFOVIR DIPIVOXIL
DIDANOSINE
EFAVIRENZ
EPIVIR
EPIVIR-HBV
LAMIVUDINE
SUSTIVA
|
New Combination |
NCT00002234 ↗ |
Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients |
Completed |
Bristol-Myers Squibb |
Phase 2 |
1969-12-31 |
The purpose of this study is to see if it is safe and effective to give HIV-infected patients
a new combination of anti-HIV drugs taken once daily.
|
| CISPLATIN
GEMCITABINE HYDROCHLORIDE
PACLITAXEL
|
New Combination |
NCT00003589 ↗ |
Combination Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer |
Completed |
European Organisation for Research and Treatment of Cancer - EORTC |
Phase 3 |
1998-08-01 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
yet known which combination chemotherapy regimen is more effective in treating advanced
non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of three different
combination chemotherapy regimens in treating patients who have advanced non-small cell lung
cancer.
|
