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Open-Label Study in Children 7-17 Years for the Treatment of Moderate to Severe Pain

Last updated on November 16, 2019

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Study Location
University of California, Irvine Health-Medical Specialties
Orange, California, 92868 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Moderate-severe Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
7-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Capsules
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
A placebo is not used in this trial
Duration
The time commitment for participation in the study.
Follow up: 1 weeks
Screening: Up to 2 weeks
Treatment: Up to 10 weeks
Site Visits
Follow up: Up to 1 visits
Screening: 1 visits
Treatment: Up to 8 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Possible
Trial Procedures
Keeping a diary
Electrocardiogram (ECG)
Physical examination
Questionnaire
Urine test
Blood test
Vital signs and measurements
NCT02101554
Pfizer
Completed
Open-Label Study in Children 7-17 Years for the Treatment of Moderate to Severe Pain

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Descriptive Information
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 SummarySafety 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 DescriptionSubjects, 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
  • Drug: Ages 7-11
    Oral/Capsule, once per day or twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 6 week Maintenance Treatment duration.
  • Drug: ages 12-17
    Oral/Capsule, once per day or twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 6 week Maintenance Treatment duration.
Study Arms  ICMJE Experimental: Embeda
One arm, open label, active
Interventions:
  • Drug: Ages 7-11
  • Drug: ages 12-17
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 Completed
Estimated Enrollment  ICMJE
 (submitted: September 22, 2014)
140
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2014)
100
Actual Study Completion Date  ICMJE June 26, 2019
Actual Primary Completion DateJune 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children 7-17 with moderate to severe pain requiring around the clock treatment with an opioid analgesic.
  • Be an experienced opioid user, defined as any subject treated with opioid therapy, equivalent or equal to >20 mg per day of morphine, for a period of 3 consecutive days immediately prior to first day of dosing.

Exclusion Criteria:

  • Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation and behavior in past year.
  • Hypersensitivity to morphine, naltrexone.
  • A life expectancy (assessed by investigator) of less than 6 months or is no longer capable of taking medication orally.
  • Undergone surgery within 3 days prior to the first day of dosing.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CountriesPuerto Rico
 
Administrative Information
NCT Number  ICMJE NCT02101554
Other Study ID Numbers  ICMJE B4541006
EMBEDA ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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