A Study to Assess the Safety and Effectiveness of Durogesic (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic Pain Requiring Long-term Narcotic Pain Relief Therapy

NCT00271453 | Completed Phase 3

• 1 other identifier: CR005950
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the effectiveness and safety of Durogesic® (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the treatment of children with chronic pain requiring long-term narcotic pain relief therapy.

Conditions

Chronic Pain

Keywords

chronic pain; opioid; fentanyl; transdermal; Durogesic; morphine

Outcome Measures

Primary Outcomes (1)

• Patient assessment of treatment at Day 15; Pain level assessed once in the morning and in the evening; Amount of rescue medication that the patient requires; Pain level at the time rescue medication is given and one hour afterwards

Secondary Outcomes (1)

• Investigator and parent global assessment of the patient's treatment with respect to pain control, side effects and convenience; Pharmacokinetics; Incidence of adverse events

Interventions

Durogesic® (fentanyl transdermal drug delivery system) DRUG

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with a confirmed malignancy (whose pain is judged by the investigator to be caused by the malignancy), or patients with other life-threatening/terminal disease whose pain requires treatment with strong opioid analgesia
• requiring treatment of pain with a strong opioid and who are expected to continue to require treatment with a strong opioid for the duration of the study
• receiving a stable dose of immediate-release oral morphine or sustained-release morphine (minimum daily dose of morphine is 30 mg/day) for at least 48 hours immediately prior to entry into the study

You may not qualify if:

• Patients with a history of allergy or hypersensitivity to fentanyl or morphine
• have active skin disease that precludes application of Durogesic® or which may affect the absorption of fentanyl
• have a clinical condition that in the investigator's judgment prevents participation in the study
• have participated in any other drug trial relating to pain control within one month of study entry
• currently participating in any other study or research project which would interfere with this trial.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Publications (1)

• Hunt A, Goldman A, Devine T, Phillips M; FEN-GBR-14 Study Group. Transdermal fentanyl for pain relief in a paediatric palliative care population. Palliat Med. 2001 Sep;15(5):405-12. doi: 10.1191/026921601680419456.

  PMID: 11591092 RESULT

Related Links

• Click here to view the journal abstract from the study manuscript.
• A study to assess the safety and effectiveness of Durogesic� fentanyl transdermal patch in the treatment of children with chronic pain requiring long-term narcotic pain relief therapy

MeSH Terms

Conditions

Chronic Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 30, 2005
• First Posted: January 2, 2006
• Study Start: February 1, 1996
• Study Completion: October 1, 1998
• Last Updated: May 18, 2011

Record last verified: 2010-04