Have you seen the statistics in Florida of the deaths and addictions to controlled substances? 

  Eligibility

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).

Other protocol-specific inclusion/exclusion criteria may apply.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192295

Contacts

Contact: Deborah Steiner, MD

203-588-7413

[email protected]

Locations

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
Estonia
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

  More Information

Additional Information:

Product Information 

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:

Malignant pain Nonmalignant pain Pediatric Opioid Moderate to severe malignant or nonmalignant pain

Additional relevant MeSH terms:

Oxycodone Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs

Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics

ClinicalTrials.gov processed this record on April 14, 2011

All comments and messages are approved by people and self promotional links or unacceptable comments are denied.

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Megan Steiner April 30, 2011 3:07 am (Pacific time)

Miss Skolek, my name is Megan Steiner. I am Deborah Steiner’s daughter, the daughter of the woman you dare to compare to Mengele. I am also a chronically ill teenager - since the age of 12 I have suffered immensely due to a one in ten million condition, and “Aunt Steiner” has suffered by my side, watching her child misdiagnosed, mistreated, and literally screaming in pain more often than not. My mother has indeed been my “protector” - she worked in this field prior to my illness, and she did so and does so because she believes that no child should suffer. If it weren’t for medications such as Oxycontin, which I have been prescribed in the past, though I am currently on another opiate, I would still be bedridden. Without my pain, I have been able to not only get out of bed, but to get into one of the top colleges in the country and battle my illness on my feet. Without people like my mother, who you have so cruelly demonized, children and teens like me could never live, not a real life. Addiction and dependency are real issues, of course, but does that mean that children in severe pain, those who truly need relief from the hell that is chronic pain, should be denied the possibility to escape the prisons that their bodies have become? Opiates were my last resort - nobody wanted to prescribe a child opiates - but they have given me a chance at a real life, one that I cherish. So while you so sarcastically and hatefully call my mother “Steiner the protector,” I do view my mother as a true protector - she protects the hopes for a pain-free, or at least a less painful life for very sick children who so desperately need that hope whilst drowning in the depths of despair and hopelessness that come with a life-sentence of pain when that life has barely begun.
My mother is no Dr. Mengele, Miss Skolek. She is a doctor who believes in helping children, not tricking them. Many drugs can be abused, and many drug companies produce such drugs. I am sorry for your daughter’s fate, but for every girl like your daughter, there is a girl like me. And as you fight for children like your daughter, protecting them from pharmaceutical companies, my mother stands by me and those like me every day, hoping to help build us a better, pain-free future.
Perhaps, Miss Skolek, when you next choose vilify some MD, you will take a moment to consider that, perhaps, behind that MD is a good person with a loving family.Sincerely,
Megan Steiner, or as I may now call myself, [“Steiner the Protector” of my mom”]

Editor: Right, well it is quite obvious that you would rally for this woman under any conditions because she is your MOM.  Funny that nobody else is put out by this, in fact it is quite the opposite.  People are grossed out and sickened by these money grubbing drug pushers who are all in it for the profits.  Hell, I’ll bet you have some digs don’t you?  Unlike all of  the kids resting six feet underground because of overdoses and issues related to good old Oxycontin and its contemporaries, your mom probably has a nice mansion for you to live and and what, the best schools?  There are methods at pain management but obviously you would only know about the ones that are drug induced.  I would like to know if you are even who you claim to be.  I am laughing, calling Marianne ‘cruel’ and claiming she ‘demonizes’ your mom, please… All of you on hard drugs, no matter what, these doctors are making you into addicts.  Medical marijuana is the unaddressed answer because the corporate cronies keep ‘demonizing’ that substance with a high level of inaccuracy.  Write a letter to the drug czar.  

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curtis April 26, 2011 4:30 pm (Pacific time)

I am a former addict to oxycontin and if I only knew how badly it was gonna affect my life I never would have started to take it. I’m not trying to sound like a broken record but every addicted person,when really thinking about it, feels the same way. I was using 2000mg a day, which never got me high anymore and I lost everything I had dear to me including my wife and three kids. I can only say that starting children on this experiment is just asking for more people to become addicted and potentially being responsible for starting them on a path to addiction. So I think its wrong and parents shouldn’t decide their fate,the children should make that decision when they become adults to make the choice for themselves.

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G April 24, 2011 5:52 pm (Pacific time)

Kids dont deserve pain relief??

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Sarah_H April 24, 2011 5:09 pm (Pacific time)

Why on earth would anyone allow or want to put their sick child on a trial of any drug that does not cure illness? unless the parents are junkies and are trying to get to the childs meds. back when i was a practicing addict (heroin) and was stupid enough to get on the methadone clinic- there were so many high school kids there on methadone due to addiction to Oxy. I guess their parents signed consent because they didnt know what else to do and the kids and clinic staff convinced the parents this was “treatment”. most all of the kids i got to know from the clinic have all died from overdoses or are still on methadone (plus oxy, plus xanax, plus various patches). like any methadone clinic- there is a lot of buying/selling/using/trading that goes on in the parking lot- all these kids knew how to shoot Oxy. somethng an old timer like me didnt even know could be done. i sucked it up and went to rehab and have been 100% clean and sober for over 5 years. while it wasnt easy, it’s much easier than staying on these drugs and it’s much less painful than a funeral. this “study” sucks and will bring many new addicts into the world. it’s hard to face the world when you’ve gotten used to the false feel good feeling of an opiate. but it can be done. it’s just a million times harder than if you just left it alone to begin with.

__________________________________________________________

Global News Centre’s Marianne Skolek, is an Investigative Reporter who focuses on the Prescription Opioid/Heroin Epidemic in the U.S. and Canada. In particular, Marianne has covered the criminal marketing of OxyContin going back to 1999 and continuing to the present.

In 2002, Marianne lost her daughter, Jill to prescribed OxyContin which her physician referred to as “mobility in a bottle.” It was, in fact, death in a bottle. After doing extensive research on the maker of OxyContin, Purdue Pharma, Marianne began working with the Department of Justice in Virginia in their criminal investigation into Purdue Pharma and in July 2007 was asked by the U.S. Attorney John Brownlee prosecuting the case to testify against the three CEO’s of Purdue Pharma, Michael Friedman, Paul Goldenheim, MD and Howard Udell, Chief Counsel. The CEO’s pleaded guilty to misleading the medical profession about the dangers of OxyContin. Marianne also testified against Purdue Pharma at a Judiciary Hearing of the U.S. Senate in July 2007.

In addition, a dangerous and highly addictive opioid named Zohydro has been approved by the FDA against their Advisory Committee’s advice and Marianne continues to alert Attorneys General, Senators and Congressmen as to the FDA’s irresponsibility in the out of control prescription opioid/heroin epidemic killing and addicting in the tens of thousands each year. Zohydro has been referred to as “heroin in a capsule” and its lowest dosage (10mg) contains twice as much hydrocodone as found in a Vicodin pill. The highest single dose of Zohydro contains as much hydrocodone as 5 to 10 tablets of Vicodin or Lortab. Zohydro mixed with alcohol can be fatal and has no abuse deterrent built in which will make it easy to crush and deliver a fatal dose of the opioid.

Currently Marianne has been instrumental in calling for the termination of Margaret Hamburg, MD, Commissioner of the FDA as well as Bob A. Rappaport, MD and Douglas Throckmorton, MD for their lack of commitment to safeguarding the American public against the prescription opioid/heroin epidemic. Marianne’s research, writing and contact with government agencies and attorneys has also exposed the heavily funded pain foundations set up by the pharmaceutical industry and their paid physician spokespersons who convinced the medical boards in 50 states and Canada that dangerous opioids such as OxyContin were less likely to be addictive. These physicians — in particular Scott Fishman, MD, J. David Haddox, DDS, MD, Perry Fine, MD, Lynn R. Webster, MD, Russell Portenoy, MD also downplayed the risks of addictive opioids in books as authors. These books are still available for sale and promoted to the medical profession.

Here are links to Marianne’s involvement in exposing the national conspiracy of the prescription opioid/heroin epidemic, the FDA, the pharmaceutical industry, their pain foundations and paid physician spokespersons.

http://www.salem-news.com/by_author.php?reporter=Marianne%20Skolek

http://www.youtube.com/watch?v=tmPG1VjD61U&list=UUWoHUEr4ZAbQOfIqtOArjgg&index=6&feature=plcp

https://www.facebook.com/photo.php?v=855537227796352&set=vb.658186307531446&type=2&theater