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Evaluate The Pharmacokinetics and Safety Of Oxycodone Oral Solution In Pediatric and Adolescent Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01959204
Recruitment Status : Recruiting
First Posted : October 9, 2013
Last Update Posted : November 28, 2018
Information provided by (Responsible Party):
VistaPharm, Inc.

Brief Summary:
The objective of this study is to characterize the pharmacokinetics and to evaluate the safety of single and multiple doses of Oxycodone Oral Solution in pediatric and adolescent subjects for postoperative pain.

Condition or disease Intervention/treatment Phase
Pain Drug: Oxycodone Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV Study to Evaluate the Pharmacokinetics and Safety of Oxycodone Oral Solution in Pediatric and Adolescent Subjects
Study Start Date : October 2013
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Open label pharmacokinetic study of oxycodone.
Drug: Oxycodone

Primary Outcome Measures :
  1. Cmax of Oxycodone Oral Solution. [ Time Frame: 24 Hours ]
    Cmax of Oxycodone Oral Solution.

Secondary Outcome Measures :
  1. Safety of Oxycodone Oral Solution in Pediatric Patients [ Time Frame: 24 Hours ]
    Safety and tolerability

Other Outcome Measures:
  1. Tmax of Oxycodone Oral Solution. [ Time Frame: 24 Hours ]
    Tmax of Oxycodone Oral Solution.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Is male or female <17 years of age at the time of dosing.
  2. Subject 2 to <17 years of age, be in at least the 25% for weight according to the Center for Disease Control pediatric growth charts and weighs at least 28 lb at the time of dosing with study drug.
  3. Is generally healthy as documented by medical history (except for the condition for which the procedure is being performed); physical examination (including, but not limited to, the cardiovascular, gastrointestinal, respiratory, and central nervous systems); vital sign assessments; 12-lead electrocardiograms; clinical laboratory assessments; and general observations. Has a negative serum pregnancy test at Screening and predose check in for females of childbearing potential.
  4. Is an outpatient for a surgical procedure and is expected to remain hospitalized for at least 24 hours after dosing with study drug.
  5. Is anticipated to have postsurgical pain requiring a parenteral analgesic regimen using a short-acting opioid analgesic and is anticipated to be switched to an oral opioid for at least 1 dose (according to institution standard of care).
  6. Has an indwelling access catheter for blood sampling.
  7. Agrees to comply with all protocol requirements. If not old enough, the legally responsible parent(s) or legal guardian(s) must agree to comply with all protocol requirements.
  8. Has been informed of the nature of the study and informed consent and assent (as appropriate) have been obtained from the legally responsible parent(s) or legal guardian(s) and the subject, respectively, in accordance with institutional review board requirements.

Exclusion Criteria:

  1. Has the presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (except for the condition for which the procedure is being performed) as determined by the clinical investigator.
  2. Has any clinical laboratory test result outside the normal range.
  3. Has a positive test result for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody.
  4. Had a clinically significant illness, except for the condition for which the procedure is being performed, in the 28 days before dosing with study drug as determined by the clinical investigator.
  5. Is a lactating or breastfeeding female.
  6. Uses any medication known to be an inhibitor or inducer of CYP3A4 within 14 days (for inhibitors such as the azole-antifungal agents voriconazole and ketoconazole, macrolide antibiotics such as erythromycin, and protease inhibitors such as ritonavir) or 28 days (for inducers such as rifampin, carbamazepine, and phenytoin) of dosing with study drug. Use of all other prescription medications, except required pre-op medications and birth control, is prohibited within 3 days of dosing with study drug. Use of any over-the-counter medications (including herbal or dietary supplements and therapeutic doses of vitamins), except for required pre-op medications, is prohibited within 24 hours of dosing with study drug, with the exception of topical spermicide. Use of St. John's wort is prohibited from 28 days before dosing until 14 days after dosing. Standard daily dose multivitamins (nontherapeutic doses) may be taken until enrollment into the study but will be restricted during the study.
  7. Consumes alcohol-, caffeine-, or xanthine-containing products within 48 hours before dosing and during periods when blood samples are collected.
  8. Consumes grapefruit, grapefruit products, Seville oranges, or pomelo-containing products within 14 days of dosing. Fruit juices, with the exception of apple and grape, will be prohibited during the study.
  9. Is a smoker or has used nicotine or nicotine-containing products within 30 days of dosing.
  10. Has a history of alcohol or drug addiction or abuse within the last year.
  11. Subject 2 to <17 years of age, has a positive urine test result for drugs of abuse (amphetamines, barbiturates, cannabinoids, cocaine metabolites, opiates, phencyclidine, and benzodiazepines) or alcohol at Screening (not required for subjects less than 2 years of age).
  12. Donated blood within 28 days or plasma within 14 days of dosing or plans to donate them within 4 weeks after completing the study.
  13. Has a history of relevant drug allergies, food allergies, or both (i.e., allergy to oxycodone, allergy to related drugs, or any significant food allergy that could interfere with the study).
  14. Is intolerant to direct venipuncture.
  15. Received an investigational drug within 28 days of dosing.
  16. Has taken oxycodone or oxymorphone within the 48 hours before anticipated dosing with study drug.
  17. Is not suitable for entry into the study in the opinion of the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01959204

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Contact: Thomas Hochadel, Pharm.D 727-897-9000
Contact: Melissa Goodhead, MSc 813-671-8570

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United States, California
CHOC Children's Hospital Recruiting
Orange, California, United States, 92688
Contact: Ofelia Vargas-Shiraishi    714-509-8735      
Principal Investigator: Jeffrey Sarmiento, MD         
United States, Florida
Miami Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Yasameen Kharazmi    786-624-2853      
Principal Investigator: Cathy Burnweit, MD         
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Jerry Owens    813-417-9950      
Principal Investigator: Charles Paidas, MD         
United States, North Carolina
UNC at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Felisha Westbrook    919-966-5136      
Principal Investigator: Robert Valley, MD         
United States, Ohio
Cincinnati Children's Hospital Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Nikki Kamos    513-803-4552      
Principal Investigator: Senthil Sadhasivam, MD         
United States, Tennessee
Vanderbilt Children 's Hospital Recruiting
Nashville, Tennessee, United States, 37232
Contact: Steven Klintworth    615-343-6223      
Principal Investigator: Andrew Franklin, MD         
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 33876
Children's Medical center Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Roxana Ploski         
Contact    214-456-8559      
Principal Investigator: Peter Szmuk, MD         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Farida Khetani    832-824-3388      
Principal Investigator: Chris Glover, MD         
Sponsors and Collaborators
VistaPharm, Inc.

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Responsible Party: VistaPharm, Inc. Identifier: NCT01959204     History of Changes
Other Study ID Numbers: 2012O004
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: October 2018
Keywords provided by VistaPharm, Inc.:
Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents