Purdue Pharma is looking for six year-old kids to take OxyContin
Makers of OxyContin Purdue Pharma are currently recruiting participants for a clinical study in the treatment of moderate and severe pain.
This are the eligibility standards that Purdue Pharma submitted on March of 2011:
Ages Eligible for Study: 6 Years to 16 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria include:
• Male and female patients aged 6 to 16 years, inclusive, who are expected to require ongoing around-the-clock opioid treatment equivalent to at least 20-mg daily dose of oxycodone for at least 2 weeks for management of moderate to severe (based on the investigator’s judgment) malignant or nonmalignant pain.
• Patients must be opioid tolerant, ie, have been treated with opioids for at least the 5 consecutive days prior to dosing and with at least 20 mg daily of oxycodone or the equivalent during at least the last 48 hours prior to the start of study drug dosing and have tolerated the therapy, as demonstrated at the start of study drug dosing.
• Patients who are currently using transdermal fentanyl should have been on the patch for at least 3 days before removing the patch and oxycodone hydrochloride (HCl) controlled-release (CR) treatment can only be initiated at least 18 hours following the removal of the transdermal fentanyl patch.
• Patients must not require more than a 240-mg total daily dose of oxycodone HCl CR tablets.
• Patients must be willing and able to swallow the oxycodone HCl CR tablets whole.
• Patients must not be currently on an investigational medication/therapy at the start of screening or during the study.
Exclusion Criteria include:
• Female patients who are pregnant or lactating.
• Patients who are allergic to oxycodone or have a history of allergies to other opioids (this criterion does not include patients who have experienced common opioid side effects [eg, nausea, constipation]).
• Patients who have received epidural opioids < 2 hours prior to the first dose of study drug or who have received epidural morphine < 12 hours prior to the first dose of study drug.
• Patients who are contraindicated for the use of opioids.
• Patients who are contraindicated for blood sampling.
• Patients who are currently being maintained on methadone for pain.
• Patients who have any planned surgery during the course of the study, with the exception of the placement of central or peripheral venous access devices.
• Patients who have had surgery within 120 hours prior to Day 1 (day of first dose of study drug).
The current hospitals that are helping conduct the study are; Loma Linda University Medical Center, LS Packard Children’s Hospital, and Bayview Research Group LLC.
The other states that are participating are Arizona, Colorado, Pennsylvania, and Texas.
The study started on November of 2010 and hopes to complete the study by September of 2011.
Purdue Pharma is estimated to have 135 participates by the end of the study.
OxyContin has already been proven to be extremely dangerous and addictive.
In 2007 Purdue Pharma pleaded guilty to criminally marketing OxyContin for saying that the pharmaceutical drug was less likely to be addictive or abused. The private pharmaceutical company was sentenced and fined.
– Cesar V.