A randomized, double-blind, placebo-controlled 12 week trial of acetaminophen extended release for the treatment of signs and symptoms of osteoarthritis.

Objective: Determine efficacy and safety of acetaminophen extended release (ER) 1300 mg given three times daily compared to placebo for relieving signs and symptoms of hip or knee osteoarthritis.

Research Design And Methods: Sixty investigators at 58 private, ambulatory, primary care sites in the US enrolled 542 outpatient adults ≥40 years old with moderate to severe idiopathic osteoarthritis pain into a randomized, placebo-controlled, double-blind 12 week clinical trial. Patients were randomly assigned to treatment given three times daily of acetaminophen 1300 mg (n = 267) or placebo (n = 275).

A randomized, placebo-controlled trial of acetaminophen extended release for treatment of post-marathon muscle soreness.

Objective: To compare the efficacy of acetaminophen extended release (ER) caplets to placebo in treating muscle soreness after a marathon.

Methods: This was a randomized, double-blind, placebo-controlled study of participants ≥ 18 years old, who completed a marathon and experienced muscle soreness rated at least 4 on a 0-to-10 numerical rating scale. The intent-to-treat efficacy analysis included 610 participants.

Multiple-dose pharmacokinetics and safety of an ibuprofen-pseudoephedrine cold suspension in children.

Two studies were conducted to characterize multiple-dose pharmacokinetics and potential drug interactions of ibuprofen and pseudoephedrine combined in a suspension and to evaluate safety of this combination in children with common cold, flu, or sinusitis. In the pharmacokinetic study, 24 healthy children aged 4-11 years were administered ibuprofen -pseudoephedrine suspension at 7.5 and 1.

A randomized, placebo-controlled trial of acetaminophen for treatment of migraine headache.

Objective: To evaluate the efficacy and safety of acetaminophen 1000 mg for the treatment of episodic migraine headache.

Background: While acetaminophen is commonly used to treat migraine, there have been limited published clinical trial efficacy results.

Design/methods: Ten investigators at 13 private, ambulatory, primary care sites in the United States enrolled and treated 346 outpatient adults 18-72 years of age with migraine headache of moderate to severe intensity into a randomized, placebo-controlled, double-blind clinical trial of 6 hours duration.

A randomized, placebo-controlled, exploratory trial of Ibuprofen and pseudoephedrine in the treatment of primary nocturnal enuresis in children.

This exploratory randomized, double-blind, double-dummy, placebo-controlled trial of 14 days duration conducted in 22 primary care practices in the United States was used to compare the efficacy of ibuprofen and pseudoephedrine, administered alone or in combination, to placebo for the treatment of primary nocturnal enuresis (PNE) in children aged 6 to 11 years. Ibuprofen (IBU) and pseudoephedrine (PSE) are not approved for the treatment of PNE. Three hundred eighteen children with PNE were enrolled.

Acetaminophen availability increases in Canada with no increase in the incidence of reports of inpatient hospitalizations with acetaminophen overdose and acute liver toxicity.

In September 1999, several Canadian provinces had place-of-sale restrictions lifted that had limited the sale of acetaminophen >325 mg and packages >24 tablets (any strength) to pharmacies only. This allowed the sale of all strengths of immediate-release acetaminophen in all package sizes in nonpharmacy locations. This study's purpose was to explore the effect that lifting restrictions on acetaminophen place of sale may have had on reported hospitalizations in Canada related to acetaminophen overdose toxicity.