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

Last updated on April 18, 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.
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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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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
Recruiting
Open-Label Study in Children 7-17 Years for the Treatment of Moderate to Severe Pain

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Moderate-severe Pain
NCT02101554
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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