Expired Study
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Clinical Trial 4290

Oklahoma City, OK 73119


Study Summary:

The study has a multicenter design to facilitate subject enrollment in a reasonable period of time in this difficult to recruit population. The starting dose in Group 1 of the pharmacokinetic, tolerability, and safety study for the 7 to 8 age group, inclusive, was chosen as 2 mg/kg/day. Following completion of all evaluations for this low dose group, the pharmacokinetic data will be evaluated to target a dose for the high dose group that will achieve a level of exposure similar to that seen with a single 200 mg ULTRAM ER dose in adults (AUC ∞ =5000 ng•h/mL). In addition, safety data will be evaluated to show that the 2 mg/kg/day dose is reasonably tolerated. To ensure a reasonable distribution of age in each group of subjects, at least 1/3 of the subjects will be female, at least 1/3 of the subjects will be male, at least 1/3 of the subjects will be below the age of 8 years (up to 7 years 364 days), and at least 1/3 of the subjects will be above the age of 10 years.


Qualified Participants Must:

• Male or female between 7 and 11 years (up to 11 years 364 days) of age, inclusive (subjects may become 12 during the study but must be 11 years of age on Day 1)
• Subject has a medically confirmed need for control of pain due to injury or nonmalignant disease that does not influence fluid shifts and general drug disposition (e.g. a subject who has undergone intra-abdominal surgery less than 3 days prior to planned administration of study drug would not be eligible
• see Section 5.2 Dosage and Administration)
• Weighs at least 20 kg
• Female subjects must be premenarchal and in the opinion of the investigator not sexually active
• Subject is able to swallow the intact tablet with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)
• Subject signed an informed assent document indicating that he/she understands the purpose of and procedures required for the study and is willing to participate in the study
• Parent(s) or the legal guardian(s) of the subject signed an informed consent document indicating that they understand the purpose of and procedures required for the study and give permission for their child’s participation in the study
• If participating in the optional pharmacogenomic research (where local regulations permit), subject signed a pharmacogenomic informed assent document indicating that he/she understands the purpose of and procedures required for this portion of the study and is willing to participate in this portion of the study
• If participating in the optional pharmacogenomic research (where local regulations permit), parent(s) or the legal guardian(s) of the subject signed a pharmacogenomic informed consent document indicating that they understand the purpose of and procedures required for this portion of the study and give permission for their child’s participation in this portion of the study
• Willing to adhere to the prohibitions and restrictions specified in this protocol


Qualified Participants May Receive:

$50 per completed Visit, $250 per overnight stay, $25 Gift Card to Wal-Mart for the subject, for a Total of $925.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.