Efficacy and safety of topiramate for the treatment of chronic migraine: a randomized, double-blind, placebo-controlled trial.

Objective: To evaluate the efficacy and safety of topiramate (100 mg/day) compared with placebo for the treatment of chronic migraine.

Methods: This was a randomized, placebo-controlled, parallel-group, multicenter study consisting of 16 weeks of double-blind treatment. Subjects aged 18 to 65 years with 15 or more headache days per month, at least half of which were migraine/migrainous headaches, were randomized 1:1 to either topiramate 100 mg/day or placebo.

Randomized study of tramadol/acetaminophen versus placebo in painful diabetic peripheral neuropathy.

Objective: To examine the efficacy and safety of tramadol/acetaminophen (APAP) for the management of painful diabetic peripheral neuropathy (DPN).

Methods: Adults with painful DPN involving the lower extremities received 37.5 mg tramadol/325 mg APAP or placebo, up to 1-2 tablets four times daily, for 66 days.

Tramadol/acetaminophen or hydrocodone/acetaminophen for the treatment of ankle sprain: a randomized, placebo-controlled trial.

Study Objective: This randomized, multicenter study compares the analgesic efficacy and safety of tramadol/acetaminophen versus hydrocodone/acetaminophen versus placebo for the treatment of acute musculoskeletal pain caused by ankle sprain.

Methods: Adults were enrolled with ankle sprain with a diagnosis of partial ligament tear, pain visual analog scale score of 50 to 100 mm (0="no pain," 100="extreme pain"), and pain numeric rating scale score of 2 to 3 (0="none," 3="severe"). Patients reported pain intensity on these scales and pain relief (-1="pain worse," 4="complete relief") hourly for 4 hours after the first dose of tramadol/acetaminophen 75 mg/650 mg, hydrocodone/acetaminophen 7.

Tramadol/acetaminophen for the treatment of acute migraine pain: findings of a randomized, placebo-controlled trial.

Objective: To compare tramadol/acetaminophen (APAP) and placebo for the management of acute migraine pain.

Background: Tramadol/APAP tablets reduced moderate-to-moderately severe acute pain in controlled studies of other painful conditions.

Methods: This randomized, double-blind, placebo-controlled, parallel group study enrolled adults with migraine pain as per International Headache Society criteria.

Topiramate for migraine prevention in children: a randomized, double-blind, placebo-controlled trial.

Objective: To assess the efficacy and safety of topiramate for the prevention of pediatric migraine with or without aura in a double-blind, randomized, placebo-controlled trial.

Background: Treatment options for pediatric migraine are currently limited, and no migraine preventive agents are approved for use in children in the United States. Topiramate is an effective migraine preventive therapy in adults, as demonstrated in several large, randomized, placebo-controlled trials.

Safety and effectiveness of topiramate for the management of painful diabetic peripheral neuropathy in an open-label extension study.

Objective: The aim of this study was to further assess the long-term safety and effectiveness of open-label topiramate therapy in subjects with moderately to severely painful diabetic peripheral neuropathy (DPN).

Methods: Adults aged 18 to 75 years received open-label topiramate (25-600 mg/d for 26 weeks) in an extension of a previously published randomized, double-blind trial comparing topiramate with placebo. Safety analyses included adverse event (AE) reports and clinical laboratory tests.

Impact of fibromyalgia pain on health-related quality of life before and after treatment with tramadol/acetaminophen.

Objective: To assess health-related quality of life (HRQOL) in patients with moderate-to-severe fibromyalgia pain compared with the general population, and to assess the relationship between pain severity and HRQOL before and after treatment with an analgesic.

Methods: Data were obtained from a randomized, double-blind study of patients with moderate-to-severe fibromyalgia pain. Patients received either tramadol/acetaminophen or placebo 4 times/day as needed for 91 days.

A double-blind placebo-controlled comparison of tramadol/acetaminophen and tramadol in patients with postoperative dental pain.

The objective of this study was to compare the analgesic efficacy of tramadol/acetaminophen (APAP) (total dose 75 mg/650 mg) and tramadol (total dose 100 mg) for the control of pain after oral surgery. A total of 456 patients with moderate-to-severe pain within 5 h after extraction of two or more third molars were randomized to receive two identical encapsulated tablets containing tramadol/APAP 37.5 mg/325 mg, tramadol 50 mg, or placebo.