Conversion From Fast Acting Oral Opioids to Abstral®

Pain Clinical Trial

Official title:

Conversion From Fast Acting Oral Opioids to Abstral® (SL Fentanyl) in Opioid Tolerant Cancer Patients With Breakthrough Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01315886
• Other study ID #: OX20-005
• Secondary ID: 2010-020239-38
• Status: Terminated
• Phase: Phase 4
• First received: March 14, 2011
• Last updated: April 3, 2017
• Start date: February 21, 2011
• Est. completion date: December 7, 2011

Study information

• Verified date: April 2017
• Source: Orexo AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 7, 2011
• Est. primary completion date: December 7, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• SL fentanyl
SL fentanyl will be administered during 7- 15 BTcP episodes during a maximum period of 21 days, following a baseline period with standard BTcP treatment. The start dose of SL fentanyl is selected individually according to a standardized conversion ratio. The maximum start dose is limited to 400 µg. For a single BTcP episode no more than two (2) tablets or a maximum dose of 800 µg should be given.

Locations

Country	Name	City	State
Sweden	Smärtavdelning B42, Anestesikliniken Karolinska University Hospital, Huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Orexo AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate in patients converted to SL fentanyl.	A subject is defined as responder if the change of Pain Intensity (PI) on the Numerical Rating Scale (NRS) rated from 0 to 10, at 30 minutes (PID30) is similar or higher after the conversion to SL fentanyl compared to baseline PID30 as assessed by standard care rescue treatment of BTcP episodes.	30 minutes post dose
Secondary	Responder rate in patients converted to SL fentanyl as assessed by the PID15.		15 minutes post dose
Secondary	Edmonton Symptom Assessment System (ESAS) Symptom Distress Score (SDS)		24 hour assessment on days with pain episodes
Secondary	Patient's global assessment of treatment (patient satisfaction).		2 occasions
Secondary	Patients preference of treatment (baseline treatment/SL fentanyl).		end of study
Secondary	Occurrence of AEs, withdrawals		during a maximum treatment period of 21 days.