Eligibility criteria
Condition
Moderate-severe Pain
Sex
Females and Males
Age
7-17 years
Inclusion criteria
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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
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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
Capsules
Placebo
A placebo is not used in this trial
Duration
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