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

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NCT02101554

Last updated on April 6, 2018
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FOR MORE INFORMATION
Study Location
Gottschalk Medical Plaza
Irvine, California, 92697 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.
Screening: Up to 2 weeks
Follow up: 1 weeks
Treatment: Up to 10 weeks
Site Visits
Screening: 1 visits
Follow up: Up to 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
Recruiting
Open-Label Study in Children 7-17 Years for the Treatment of Moderate to Severe Pain

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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.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Moderate-severe Pain
  • 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.
Experimental: Embeda
One arm, open label, active
Interventions:
  • Drug: Ages 7-11
  • Drug: ages 12-17
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
December 21, 2019
December 21, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
7 Years to 17 Years   (Child)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Puerto Rico,   United States
 
 
NCT02101554
B4541006
EMBEDA ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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