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Kids: the New Guinea Pigs for Oxycontin Maker Purdue Pharma
Marianne Skolek Salem-News.com
"The more we do to you, the less you seem to believe we are doing it." - Dr. Josef Mengele, Infamous Nazi Doctor
(MYRTLE BEACH, Calif.) - Purdue Pharma, maker of the criminally marketed drug, OxyContin is actively "recruiting" participants for clinical studies in the treatment of "moderate" to "severe" pain -- in children ages 6 to 16!!!
Every state in the country - as well as Canada - is fighting an unwinnable war in addiction, death and abuse of OxyContin because of the criminal marketing by Purdue Pharma of this drug -- as less likely to be addictive or abused. The company pleaded guilty to these charges in Federal Court and was sentenced and fined in 2007.
Is the FDA going to allow Purdue Pharma to further addict and kill our most vulnerable and defenseless -- our children? Will members of Congress and the Senate step up and end this greed and madness perpetrated by an out of control private pharmaceutical company - Purdue Pharma?
The reference below in Purdue Pharma's recruitment for children indicates that "Patients must not require more than a 240-mg total daily dose of oxycodone HCI CR tablets." There would be no further requirement of a 240 mg total daily dose to a child -- there would be no tomorrow for that child.
When the "Angel of Death", Dr. Josef Mengele visited his child "experiments" in death camps during the Holocaust, he introduced himself as "Uncle Mengele" -- and offered them sweets. Some survivors remember that despite his grim acts, he was also called "Mengele the Protector."
So Deborah Steiner, MD, Purdue Pharma, when you recruit these children ages 6 to 16 -- and give them the same fate that scores of victims have fallen prey to in every state in the country in death and addiction from OxyContin -- should these same children call you -- "Aunt Steiner" or "Steiner the Protector?"
Here is the recruitment filing Purdue Pharma is using to market for young children.
Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
This study is currently recruiting participants.
Verified on March 2011 by Purdue Pharma LP
|Sponsor: ||Purdue Pharma LP |
|Information provided by: ||Purdue Pharma LP|
|ClinicalTrials.gov Identifier: ||NCT01192295| Purpose
The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.
|Study Type: ||Interventional |
|Study Design: ||Allocation: Non-Randomized|
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title: ||An Open-label, Multicenter Study of the Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children From Ages 6 to 16 Years Old, Inclusive, With Moderate to Severe Malignant and/or Nonmalignant Pain Requiring Opioid Analgesics|
Resource links provided by NLM:
Further study details as provided by Purdue Pharma LP:
Primary Outcome Measures:
- The number of participants with adverse events as a measure of safety. [ Time Frame: Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment). ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To characterize the efficacy and provide additional pharmacokinetics (PK) data of oxycodone hydrochloride controlled-release tablets [ Time Frame: 2-4 and 4-6 hours (hrs) after the first dose on Day 1 and immediately pre-dose and 2-4 hrs after dose at Visit 2 and/or Visit 3. ] [ Designated as safety issue: No ]
To characterize the efficacy and provide additional pharmacokinetics (PK) data for a population PK model of oxycodone hydrochloride controlled-release tablets in opioid tolerant pediatric patients aged 6 to16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.
|Estimated Enrollment: ||135|
|Study Start Date: ||November 2010|
|Estimated Study Completion Date: ||September 2011|
|Estimated Primary Completion Date: ||September 2011 (Final data collection date for primary outcome measure)|
|Arms ||Assigned Interventions |
|Oxycodone HCl controlled-release: Experimental |
Oxycodone hydrochloride (HCl) controlled-release (CR)
Intervention: Drug: Oxycodone HCl controlled-release tablets
|Drug: Oxycodone HCl controlled-release tablets |
Oxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours.
|Ages Eligible for Study: ||6 Years to 16 Years|
|Genders Eligible for Study: ||Both|
|Accepts Healthy Volunteers: ||No|
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).
Other protocol-specific inclusion/exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192295
|United States, Arizona|
|Maricopa Medical Center ||Recruiting|
|Phoenix, Arizona, United States, 85008 |
|Contact: David Rosenberg, MD |
|Principal Investigator: David Rosenberg, MD |
|United States, California|
|Loma Linda University Medical Center ||Recruiting|
|Loma Linda, California, United States, 92354 |
|Contact: Peter Przekop, MD |
|Principal Investigator: Peter Przekop, MD |
|LS Packard Children's Hospital ||Recruiting|
|Palo Alto, California, United States, 94304 |
|Contact: Elliot Krane, MD |
|Principal Investigator: Elliot Krane, MD |
|Bayview Research Group, LLC ||Recruiting|
|Paramount, California, United States, 90723 |
|Contact: Mohammad Riaz, MD |
|Principal Investigator: Mohammad Riaz, MD |
|United States, Colorado|
|The Children's Hospital ||Recruiting|
|Aurora, Colorado, United States, 80045 |
|Contact: Jeffrey Galinkin, MD |
|Principal Investigator: Jeffrey Galinkin, MD |
|United States, Pennsylvania|
|Penn State Hershey Children's Hospital ||Recruiting|
|Hershey, Pennsylvania, United States, 17033 |
|Contact: Andrew S. Freiberg, MD |
|Principal Investigator: Andrew S. Freiberg, MD |
|United States, Texas|
|Children's Medical Ctr of Dallas ||Recruiting|
|Dallas, Texas, United States, 75235 |
|Contact: Peter Szmuk, MD |
|Principal Investigator: Peter Szmuk, MD |
|Tallinn Children's Hospital ||Recruiting|
|Tallinn, Estonia, 13419 |
|Contact: Kadri Saks, MD |
|Principal Investigator: Kadri Saks, MD |
|Tartu University Hospital ||Recruiting|
|Tartu, Estonia, 51014 |
|Contact: Karin Varik, MD, Ph.D. |
|Principal Investigator: Karin Varik, MD, Ph.D. |
Sponsors and Collaborators
Purdue Pharma LP
No publications provided
|Responsible Party: ||Purdue Pharma LP ( Medical Monitor )|
|ClinicalTrials.gov Identifier: ||NCT01192295 History of Changes |
|Other Study ID Numbers: ||OTR3001, 2010-020471-23|
|Study First Received: ||August 30, 2010|
|Last Updated: ||March 28, 2011|
|Health Authority: ||United States: Food and Drug Administration; Estonia: State Agency of Medicines|
Keywords provided by Purdue Pharma LP:
Moderate to severe malignant or nonmalignant pain
Additional relevant MeSH terms:
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Central Nervous System Depressants
ClinicalTrials.gov processed this record on April 14, 2011
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