WithdrawnPhase 3

Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects

Stopped: The study is no longer required for the PREA for this product.

0Started 2010-10

Plain-language summary

The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having severe to moderate chronic pain.

Who can participate

Age range2 Years – 6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Males or females 2 to ≤6 years of age, inclusive
✓. Chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose \>1 mg/kg qd oral morphine equivalent)
✓. Expected to continue to require a strong opioid for pain relief for at least 4 months
✓. Able to swallow the oxymorphone HCl immediate-release oral liquid
✓. Have been informed of the nature of the study and informed consent and assent by minor (if IRB required) has been obtained from the legally responsible parent/legal guardian in accordance with IRB requirements

Exclusion criteria

✕. Known allergy to, or a significant reaction to, oxymorphone or another opioid
✕. Life expectancy \<4 months
✕. Any clinical condition in the investigator's opinion that would preclude participation
✕. Plan to undergo a surgical procedure within 1 month of study entry or anytime during study
✕. Currently prescribed a long-acting opioid (eg., Kadian® morphine sulfate extended release) as part of their analgesic regimen
✕. Received any investigational medication within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than oxymorphone during the course of the study
✕. An ileostomy
✕. Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study medication

What they're measuring

Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.

Timeframe: weekly for 1 month during titration

Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.

Timeframe: bi-weekly for three months in the maintenance phase

Trial details

NCT IDNCT01206907

SponsorEndo Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Chronic Pain trials

Who can participate

Age range2 Years – 6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Males or females 2 to ≤6 years of age, inclusive
✓. Chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose \>1 mg/kg qd oral morphine equivalent)
✓. Expected to continue to require a strong opioid for pain relief for at least 4 months
✓. Able to swallow the oxymorphone HCl immediate-release oral liquid
✓. Have been informed of the nature of the study and informed consent and assent by minor (if IRB required) has been obtained from the legally responsible parent/legal guardian in accordance with IRB requirements

Exclusion criteria

✕. Known allergy to, or a significant reaction to, oxymorphone or another opioid
✕. Life expectancy \<4 months
✕. Any clinical condition in the investigator's opinion that would preclude participation
✕. Plan to undergo a surgical procedure within 1 month of study entry or anytime during study
✕. Currently prescribed a long-acting opioid (eg., Kadian® morphine sulfate extended release) as part of their analgesic regimen
✕. Received any investigational medication within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than oxymorphone during the course of the study
✕. An ileostomy
✕. Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study medication

What they're measuring

Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.

Timeframe: weekly for 1 month during titration

Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.

Timeframe: bi-weekly for three months in the maintenance phase