Open-Label Study in Children 7-17 Years for the Treatment of Moderate to Severe Pain
NCT02101554
ABOUT THIS STUDY
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- Children 7-17 with moderate to severe pain requiring around the clock treatment with an opioid.
- Be an experienced opioid user, equivalent or equal to >20 mg per day of morphine, for a period of 3 consecutive days immediately prior to first day of dosing.
- Allergy to morphine, naltrexone.
- Cannot have a life expectancy of less than 6 months.
- Is not able to take medication orally.
- Undergone surgery within 3 days prior to the first day of dosing.
- Cannot be pregnant or attempting pregnancy.
- Cannot have a positive urine test for illicit drugs.
- Any planned surgery during the course of the study.
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Descriptive Information | |||||||
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Brief Title ICMJE | Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain | ||||||
Official Title ICMJE | AN OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF PF-06412528 IN CHILDREN 7-17 YEARS FOR THE TREATMENT OF MODERATE-TO-SEVERE PAIN | ||||||
Brief Summary | Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of morphine sulfate with a sequestered naltrexone core in children 7-17 with moderate-severe pain. | ||||||
Detailed Description | Subjects, once stabilized to Embeda, need only complete a minimum of 2 of the 6 week study duration to satisfy the PK endpoint. A safety follow-up visit is required at 1 week post-last dose. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Moderate-severe Pain | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Embeda
One arm, open label, active Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE | 19 | ||||||
Original Estimated Enrollment ICMJE | 100 | ||||||
Actual Study Completion Date ICMJE | June 26, 2019 | ||||||
Actual Primary Completion Date | June 26, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 7 Years to 17 Years (Child) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | Puerto Rico | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02101554 | ||||||
Other Study ID Numbers ICMJE | B4541006 EMBEDA ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | June 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |