Phase 3
Results from a Phase 3 study, published in the March issue of Pediatrics, demonstrate that Metadate CD (Celltech Pharmaceuticals, Inc., Rochester, NY, methylphenidate HCl, USP) Extended-Release Capsules (CII), 20 mg, when administered once daily before school, can control attention deficit hyperactivity disorder (ADHD) symptoms during the school day without the need for a second midday dose. The primary efficacy measure was the difference in severity of ADHD symptoms from baseline on the teacher version of Conners' Global Index. The mean improvement from baseline was 7.9 for the study drug, compared to 1.2 for placebo. The randomized, double-blind, parallel-group, placebo-controlled study involved 314 subjects, ages 6 to 15, who had been diagnosed with ADHD. The study involved a one-week, single-blind, placebo wash-out period followed by a three-week, double-blind titration and treatment period, during which subjects were administered individually titrated doses of 20, 40, or 60 mg daily with matching placebo. The study's primary objective was to compare the efficacy, safety, and tolerability of the study drug with placebo.
Subjects using Estrasorb (Novavax, Inc., Columbia, MD, estradiol topical emulsion) reported an 85% reduction in total number of hot flashes. Approximately half the subjects reported complete cessation of hot flashes during a seven-day period by week 10. Less than 10% of subjects in the placebo group noticed similar improvement in symptoms. Adverse events were similar to placebo and consistent with estrogens as a class, the most common included endometrial disorder, breast pain, vaginal hemorrhage, and vaginal moniliasis. This randomized, double-blind, placebo-controlled, Phase 3 trial enrolled 200 women who were naturally or surgically menopausal, and consisted of a three-week screening period, a one-week placebo period, and a 12-week treatment period. A 3-gram dose of the study drug with 7.5-mg estradiol or placebo emulsion was applied daily to each thigh and calf. Hot flash data was collected and recorded in subject diaries.
Two Phase 3 trials tested a single injection of Vitrase (ISTA Pharmaceuticals, Inc., Irvine, CA) to clear vitrous hemorrhage sufficient to allow the diagnosis and appropriate treatment of the underlying cause of the hemorrhage within three months following treatment. Preliminary results showed no statistically significant improvement in the primary endpoint, but researchers observed clinically relevant improvements in visual acuity. The two randomized, double-masked, placebo-controlled studies involved 1306 subjects. In North America, 750 subjects were assigned to one of four treatment arms; elsewhere, 556 subjects were assigned to three treatment arms.
The January 2002 issue of the Journal of Clinical Oncology reports on Alfacell Corporation's (Bloomfield, NJ) pivotal, multinational, randomized Phase 3 trial of Onconase for the treatment of patients with inoperable malignant mesothelioma. Six of the 81 evaluable subjects showed clear antitumor activity; in an additional 35, mesothelioma growth ceased. Despite the fact that 24 of the 105 subjects were in prognostically poor groups, the median survival of the subjects who entered the trial without symptoms from the cancer was 18.5 months. The drug is being studied as a single agent at 33 U.S. centers and in combination with doxorubicin in...