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WithdrawnNCT01206907Updated Aug 17, 2012

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

A Phase 3 interventional study of oxymorphone IR in Chronic Pain, sponsored by Endo Pharmaceuticals. Withdrawn. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2012-08-17.

Sponsored by Endo Pharmaceuticals · Phase 3, Interventional, and Treatment

Why this study was withdrawn
The study is no longer required for the PREA for this product.
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
2 Years to 6 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Pain

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Keywords

  • sickle cell anemia
  • juvenile rheumatoid arthritis
  • burn victim
  • cancer
  • Chronic pain of malignant or non-malignant etiology
03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

Browse Chronic Pain studies →

Lead sponsor

Endo Pharmaceuticals is the lead sponsor of 100 studies on the registry; none are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Males or females 2 to ≤6 years of age, inclusive
  2. 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)
  3. Expected to continue to require a strong opioid for pain relief for at least 4 months
  4. Able to swallow the oxymorphone HCl immediate-release oral liquid
  5. 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

Exclusion Criteria:

  1. Known allergy to, or a significant reaction to, oxymorphone or another opioid
  2. Life expectancy \<4 months
  3. Any clinical condition in the investigator's opinion that would preclude participation
  4. Plan to undergo a surgical procedure within 1 month of study entry or anytime during study
  5. Currently prescribed a long-acting opioid (eg., Kadian® morphine sulfate extended release) as part of their analgesic regimen
  6. 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
  7. An ileostomy
  8. Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study medication
  9. Investigator anticipates that the subject would be unable to comply with the protocol
  10. Parent/legal guardian is unable to complete the subject's daily study medication diary
  11. Parent/legal guardian is unable to effectively communicate the subject's status to the investigator
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • Drugoxymorphone IR

    oxymorphone IR liquid

06

What researchers measure

Primary outcomes

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

    Time frame: weekly for 1 month during titration

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

    Time frame: bi-weekly for three months in the maintenance phase

Secondary outcomes

  1. Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.

    Time frame: weekly for 1 month during titration

  2. Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.

    Time frame: bi-weekly for 3 months in the maintenance phase

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01206907
Lead sponsor
Endo Pharmaceuticals
First posted
Sep 22, 2010
Start date
Oct 2010
Primary completion
Dec 2013 (estimated)
Completion
Dec 2013 (estimated)
Last update
Aug 17, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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