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Clinical Trials for Children - OxyContin
Marianne Skolek Salem-News.com
" The corruption scandal is all about energy, Iraq and the prescription drug mess -- the dominant issues for the public." - James Carville
(MYRTLE BEACH, SC) - In April 2011, I wrote an article for Salem-News.com (link provided below) about Purdue Pharma, maker of the deadly drug, OxyContin recruiting children ages 6 to 16 for clinical trials with malignant and nonmalignant pain and the "safety" of administrating children OxyContin.
Below is what appears to be the "final" filing for these trials before the Federal Drug Administration (FDA) reviews the clinical trials information and approves OxyContin for use in children. As criminal and ludicrous as these trials are, I am confident that the FDA will approve this deadly drug to be given to children. Neither Purdue Pharma -- nor the FDA -- has any conscience in the devastation in human life OxyContin has waged in the United States and Canada since it was unleashed on the public in 1996. At the end of this article is the final filing by Purdue Pharma to addict and kill young children for "moderate" "non-cancer" pain.
I am not the only voice of sanity in this outrage of Purdue Pharma putting more profits above human life -- and now the lives of our precious children. Last year, Tim Cheney of Choopers Guide http://www.choopersguide.com/ wrote about these clinical trials for children saying it was not his practice to endorse or oppose issues, products and causes that are politically contentious. He further states that Choopers Guide does not purport to be experts in clinical pharmacology, nor are they physicians. They do understand addiction, the mindset of the addict and the fundamental biological, psychological, social and spiritual facets of addiction and they would be "morally remiss if they withheld commentary." They decided to make an exception and offer a few common sense comments of the clinical trial of OxyContin being administered to children.
• OxyContin abuse statistics surged from 2.1% to 25.6% in age group 12-25 in the last decade
• OxyContin treatment admission by primary drug of abuse increased from 2.2% to 9.8% in the last decade
• OxyContin was listed as the cause of death in 1,185 cases in Florida in 2009
• Purdue Pharma OxyContin Revenues: 2010 - 3.1 billion; 2009 – 2.8 billion
• OxyContin accounts for approximately 90% of Purdue Pharma Revenues
• There are 178 Pill Mills in Southern Florida that generate 85% of the nations OxyContin prescriptions.
Mr. Cheney further stated on the Choopers Guide website "It is not the author’s intention to question the legitimacy or efficacy of this drug as an analgesic but rather to assert the position that the public perception is that OxyContin is no longer just another narcotic pain reliever. It has lost its medical legitimacy due to the incidence and prevalence of abuse and addiction and its association with the disease of addiction.
By allowing this proposed usage of this drug we are in essence conveying our apathy or tacit approval of putting profits ahead of our childrens’ futures.
In closing, I would like to extend my congratulations to Purdue Pharma, the news media and Hollywood. You have successfully created an epidemic based upon deliberate misrepresentation and glamorization of the pharmaceutical properties of an opioid analgesic to the medical industry and to the news media industry for providing the nation with sensationalistic media coverage that is killing people, destroying families, clogging our criminal justice system and costing society hundreds of billions of dollars per year. And, you have done it without one shred of remorse."
I applaud Mr. Cheney for speaking out as an addiction specialist and walking the walk with hundreds of thousands of victims dealing with the addictive qualities of OxyContin and his outrage at the very real possibility that the FDA will approve OxyContin for use in children -- thus continuing their grim reaper relationship with Purdue Pharma -- and yes without one shred of remorse.
LP -- So much to look forward to on our journeys -- and I promise to keep you in chicken noodle soup and apple pie. It feeds the peace, faith, and most of all the love. Thanks for my "Tebow" surprise. You are the best!
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 April 2012 by Purdue Pharma LP
| Sponsor: || Purdue Pharma LP |
|Information provided by (Responsible Party): ||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:||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:||154|
| Study Start Date: ||November 2010|
| Estimated Study Completion Date:||April 2012|
| Estimated Primary Completion Date: ||April 2012 (Final data collection date for primary outcome measure)|
| Arms || Assigned Interventions |
| Experimental: Oxycodone HCl controlled-release |
Oxycodone hydrochloride (HCl) controlled-release (CR)
| 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.
Other Name: OxyContin
|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 5 days prior to Day 1 (day of first dose of study drug).
- Patients who, in the investigator's opinion, have an underlying gastrointestinal condition or other disorder that may predispose them to obstruction.
Other protocol-specific inclusion/exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192295
Contacts Show 98 Study Locations
Sponsors and Collaborators
Purdue Pharma LP
No publications provided
|Responsible Party:||Purdue Pharma LP|
|ClinicalTrials.gov Identifier: ||NCT01192295 History of Changes |
|Other Study ID Numbers:||OTR3001, 2010-020471-23|
|Study First Received:||August 30, 2010 |
|Last Updated:||April 3, 2012|
|Health Authority:||United States: Food and Drug Administration|
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Ministry of Health
New Zealand: Medsafe
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Romania: Ministry of Public Health
Guatemala: Ministry of Public Health and Social Assistance
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Keywords provided by Purdue Pharma LP:
| Malignant pain|
Moderate to severe malignant or nonmalignant pain
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 12, 2012
| Analgesics, Opioid|
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
| Pharmacologic Actions|
Central Nervous System Agents
Central Nervous System Depressants
Salem-News.com Investigative Reporter Marianne Skolek, is an Activist for Victims of OxyContin and Purdue Pharma throughout the United States and Canada. In July 2007, she testified against Purdue Pharma in Federal Court in Virginia at the sentencing of their three CEO's - Michael Friedman, Howard Udell and Paul Goldenheim - who pleaded guilty to charges of marketing OxyContin as less likely to be addictive or abused to physicians and patients. She also testified against Purdue Pharma at a Judiciary Hearing of the U.S. Senate in July 2007. Marianne works with government agencies and private attorneys in having a voice for her daughter Jill, who died in 2002 after being prescribed OxyContin, as well as the voice for scores of victims of OxyContin. She has been involved in her work for the past 8-1/2 years and is currently working on a book that exposes Purdue Pharma for their continued criminal marketing of OxyContin.
Marianne is a nurse having graduated in 1991 as president of her graduating class. She also has a Paralegal certification. Marianne served on a Community Service Board for the Courier News, a Gannet newspaper in NJ writing articles predominantly regarding AIDS patients and their emotional issues. She was awarded a Community Service Award in 1993 by the Hunterdon County, NJ HIV/AIDS Task Force in recognition of and appreciation for the donated time, energy and love in facilitating a Support Group for persons with HIV/AIDS.
Investigative Reporter for Salem-News.com
Victims of OxyContin and Purdue Pharma - a criminally convicted pharmaceutical company
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