Conversion From Fast Acting Oral Opioids to Abstral®

NCT01315886 | Terminated Phase 4

• 2 other identifiers: OX20-0052010-020239-38
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pain

Keywords

sublingual; fentanyl; titration; conversion; breakthrough cancer pain; pain intensity difference; PID; Edmonton Symptom Assessment System; ESAS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Responder rate in patients converted to SL fentanyl as assessed by the PID15.

  15 minutes post dose

• Edmonton Symptom Assessment System (ESAS) Symptom Distress Score (SDS)

  24 hour assessment on days with pain episodes

• Patient's global assessment of treatment (patient satisfaction).

  2 occasions

• Patients preference of treatment (baseline treatment/SL fentanyl).

  end of study

• Occurrence of AEs, withdrawals

  during a maximum treatment period of 21 days.

Study Arms (1)

SL Fentanyl conversion

EXPERIMENTAL

* Baseline period: 7-15 episodes of breakthrough cancer pain treated with prior IR opioid medication * Treatment period: Conversion to SL Fentanyl at a Fentanyl:Prior opioid conversion factor of 1:50 (using the estimated Morphine Sulphate Equivalent dose for the prior opioid). SL Fentanyl use was followed for 8-15 episodes of breakthrough cancer pain. SL Fentanyl dose could be titrated between episodes.

Drug: SL fentanyl

Interventions

SL fentanyl DRUG

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.

Also known as: Abstral

SL Fentanyl conversion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent obtained.
• years or older, of both genders.
• Opioid tolerant patients
• Estimated frequency of BTcP 0.5-4 times a day.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orexo AB: lead

Study Sites (1)

Smärtavdelning B42, Anestesikliniken Karolinska University Hospital, Huddinge

Stockholm, SE-141 86, Sweden

Location

MeSH Terms

Conditions

Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Anders Pettersson, MD, PhD

  Orexo AB

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 15, 2011
• Study Start: February 21, 2011
• Primary Completion: December 7, 2011
• Study Completion: December 7, 2011
• Last Updated: April 5, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)