PainPhase 4NCT01315886
Conversion From Fast Acting Oral Opioids to Abstral®
A Phase 4 study testing SL fentanyl in people with Pain, run by Orexo AB at 1 site in Sweden.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- SL fentanyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- 21 Feb 2011to 7 Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent obtained.
- 18 years or older, of both genders.
- Opioid tolerant patients
- Estimated frequency of BTcP 0.5-4 times a day.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Smärtavdelning B42, Anestesikliniken Karolinska University Hospital, Huddinge
Stockholm, SE-141 86
About this study
Official title: Conversion From Fast Acting Oral Opioids to Abstral® (SL Fentanyl) in Opioid Tolerant Cancer Patients With Breakthrough Pain
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).
Read the 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.
- Conditions
- Pain
- Being tested
- SL fentanyl
- Keywords
- sublingual, fentanyl, titration, conversion, breakthrough cancer pain, pain intensity difference, PID, Edmonton Symptom Assessment System, ESAS
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SL fentanylDrug
Also called Abstral
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: SL fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes post dose
Secondary outcomes (5)
Responder rate in patients converted to SL fentanyl as assessed by the PID15.
Measured: 15 minutes post dose
Edmonton Symptom Assessment System (ESAS) Symptom Distress Score (SDS)
Measured: 24 hour assessment on days with pain episodes
Patient's global assessment of treatment (patient satisfaction).
Measured: 2 occasions
Patients preference of treatment (baseline treatment/SL fentanyl).
Measured: end of study
Occurrence of AEs, withdrawals
Measured: during a maximum treatment period of 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study start21 Feb 2011
- Primary completion7 Dec 2011
- Study completion7 Dec 2011
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orexo AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Pettersson, MD, PhD, Study chair, Orexo AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315886
- Sponsor's protocol ID
- OX20-005
- Other IDs
- 2010-020239-38
- Status last verified
- Apr 2017
- First submitted
- 14 Mar 2011
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion From Fast Acting Oral Opioids to Abstral® (SL Fentanyl) in Opioid Tolerant Cancer Patients With Breakthrough Pain
- ClinicalTrials.gov ID
- NCT01315886
- Acronym / sponsor ID
- OX20-005
- Conditions
- Pain
- Keywords
- sublingual, fentanyl, titration, conversion, breakthrough cancer pain, pain intensity difference, PID, Edmonton Symptom Assessment System
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Orexo ABIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2011 (actual)
- Primary completion
- 7 Dec 2011 (actual)
- Study completion
- 7 Dec 2011 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SL Fentanyl conversion | Experimental | Drug: SL fentanyl* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent obtained.
- 18 years or older, of both genders.
- Opioid tolerant patients
- Estimated frequency of BTcP 0.5-4 times a day.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SL fentanylAlso: AbstralSL 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. | Drug | SL Fentanyl conversion |
Primary outcome
Response rate in patients converted to SL fentanyl.
Time frame: 30 minutes post dose
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.
5 secondary outcomes
Responder rate in patients converted to SL fentanyl as assessed by the PID15.
Time frame: 15 minutes post dose
Edmonton Symptom Assessment System (ESAS) Symptom Distress Score (SDS)
Time frame: 24 hour assessment on days with pain episodes
Patient's global assessment of treatment (patient satisfaction).
Time frame: 2 occasions
Patients preference of treatment (baseline treatment/SL fentanyl).
Time frame: end of study
Occurrence of AEs, withdrawals
Time frame: during a maximum treatment period of 21 days.
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Pettersson, MD, PhD study chair
Orexo AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SL fentanyl in people with Pain, run by Orexo AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate in patients converted to SL fentanyl. (time frame: 30 minutes post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.