Conversion From Fast Acting Oral Opioids to Abstral�
Information source: Orexo AB
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: SL fentanyl (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Orexo AB Official(s) and/or principal investigator(s):
Anders Pettersson, MD, PhD, Study Chair, Affiliation: Orexo AB
Overall contact:
Jan Persson, MD, PhD, Phone: +46 8 58580000, Email: jan.persson@karolinska.se
Summary
The purpose of this study is to evaluate safety and efficacy when using a novel dose
conversion strategy to switch from immediate release oral opioids to sublingual (SL)
fentanyl (Abstral) for treatment of breakthrough cancer pain (BTcP).
Clinical Details
Official title: Conversion From Fast Acting Oral Opioids to Abstral® (SL Fentanyl) in Opioid Tolerant Cancer Patients With Breakthrough Pain
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Response rate in patients converted to SL fentanyl.
Secondary outcome: Responder rate in patients converted to SL fentanyl as assessed by the PID15.Edmonton Symptom Assessment System (ESAS) Symptom Distress Score (SDS) Patient's global assessment of treatment (patient satisfaction). Patients preference of treatment (baseline treatment/SL fentanyl). Occurrence of AEs, withdrawals
Detailed description:
The study aims to show that in the advanced stage of cancer the individual patient already
on high doses of BTcP medication will benefit from starting treatment on a higher first dose
of SL fentanyl thus reducing the number of dosing steps with insufficient pain relief.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Signed informed consent obtained.
- 18 years or older, of both genders.
- Opioid tolerant patients
- Estimated frequency of BTcP 0. 5-4 times a day.
Exclusion Criteria:
- Treatment with SL fentanyl within two weeks prior to screening.
- Recent or planned therapy that would alter pain or responses to analgesics.
- Treatment with monoamine oxidase inhibitor < 14 days before or concurrent with SL
fentanyl treatment.
- Significantly reduced liver and/or kidney function.
- Significant prior history of substance abuse.
- Pregnancy, breast feeding or woman of childbearing potential not using adequate
birth control.
Locations and Contacts
Jan Persson, MD, PhD, Phone: +46 8 58580000, Email: jan.persson@karolinska.se
Smärtavdelning B42, Anestesikliniken Karolinska University Hospital, Huddinge, Stockholm SE-141 86, Sweden; Recruiting
Additional Information
Starting date: February 2011
Last updated: August 24, 2011
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