PainPhase 3NCT00263575

Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients

A Phase 3 study testing EN3267 in people with Pain and Cancer, run by Kyowa Kirin Co., Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the long-term safety and effectiveness of EN3267 in treating breakthrough pain episodes in opioid cancer patients who are using stable doses of opioid medication. Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Pain, Cancer
What is being tested?: EN3267
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 139 participants
Where: 1 siteUnited States
Study dates: Dec 2005to Jan 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 17 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Males or females 17 years of age or older.
Stable cancer-related pain.
Are receiving a stable, fixed-schedule oral opioid regimen equivalent to 60 to 1000 mg of oral morphine per day or transdermal fentanyl therapy equivalent to 50 to 300 µg/h, and are on a stable dose of opioid medication for relief of breakthrough pain.
Experiencing 1-4 episodes of breakthrough pain per day.
Meet the criteria defined in the Eastern Cooperative Oncology Group (ECOG) Performance Status for Grade 0, 1, or 2.

Who cannot join

Have previously been exposed to EN3267.
Are pregnant or lactating.
Have uncontrolled or rapidly escalating pain.
Have any clinically significant condition that would, in the investigator's opinion, preclude participation in the study or compromise data collection. These conditions may include cardiopulmonary disease, and/or neurologic/psychologic conditions.
Are scheduled to take MAOIs (monoamine oxidase inhibitors) during the study.
Are scheduled to receive anti-neoplastic therapy that, in the investigator's opinion, will influence assessment of breakthrough pain.

Show all 11Show fewer

Are scheduled to receive an investigational drug other than EN3267 during the course of the study.
Have hypersensitivity, allergy or contraindication to fentanyl.
Have significant prior history of substance abuse or alcohol abuse.
Would have difficulty complying with the protocol, as assessed by the investigator.
Are unable to read, write, or comprehend the English language in order to complete diaries.

Trial locations and contacts

1 site in 1 country.

United States1 site

Carolinas Pain Institute
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Multiple-Dose, Non-Randomized, Open-Label, Multicenter Study to Evaluate the Long-Term Safety and Effectiveness of EN3267 in the Treatment of Breakthrough Pain in Cancer Patients

Read the detailed description

This was a Phase 3 non-randomized, open-label, multicentre study designed to evaluate the long-term safety of EN3267 in the treatment of BTcP in opioid-tolerant cancer patients. The study was conducted in 2 parts:

A Titration Period during which patients had up to 2 weeks to determine a single, effective dose of study medication (EN3267) for adequate treatment of BTcP, and
A maintenance Period of up to 12 months in which episodes of BTcP were treated with study medication.

Conditions: Pain, Cancer
Being tested: EN3267
Keywords: EN3267, Breakthrough Pain, Safety Study, Fentanyl Tablets
Medical subject headings: Pain, Neoplasms, Breakthrough Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EN3267Drug
Also called Fentanyl
EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses

Study groups in NCT00263575
Study group	Role	What they receive
sublingual fentanyl tablet	Experimental	Not described Receives: Drug: EN3267

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate the Long-term Safety and Effectiveness of EN3267
Measured: screening, 2 week titration period and 12 monthly study visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2005Jan 2009

First posted9 Dec 2005 (estimated)
Study startDec 2005
Primary completionDec 2008
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00263575
Sponsor's protocol ID: EN3267-007
Status last verified: Jun 2024
First submitted: 7 Dec 2005
Last updated: 18 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Nalamachu S, Hassman D, Wallace MS, Dumble S, Derrick R, Howell J. Long-term effectiveness and tolerability of sublingual fentanyl orally disintegrating tablet for the treatment of breakthrough cancer pain. Curr Med Res Opin. 2011 Mar;27(3):519-30. doi: 10.1185/03007995.2010.545380. Epub 2011 Jan 6.
PubMed 21208151

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple-Dose, Non-Randomized, Open-Label, Multicenter Study to Evaluate the Long-Term Safety and Effectiveness of EN3267 in the Treatment of Breakthrough Pain in Cancer Patients
ClinicalTrials.gov ID: NCT00263575
Acronym / sponsor ID: EN3267-007
Conditions: Pain, Cancer
Keywords: EN3267, Breakthrough Pain, Safety Study, Fentanyl Tablets
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 139 participants (actual)
Lead sponsor: Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
Study start: Dec 2005
Primary completion: Dec 2008 (actual)
Study completion: Jan 2009 (actual)
First posted: 9 Dec 2005 (estimated)
Results: Posted 19 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

A Titration Period during which patients had up to 2 weeks to determine a single, effective dose of study medication (EN3267) for adequate treatment of BTcP, and
A maintenance Period of up to 12 months in which episodes of BTcP were treated with study medication.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
sublingual fentanyl tablet	Experimental	Drug: EN3267

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Males or females 17 years of age or older.
Stable cancer-related pain.
Are receiving a stable, fixed-schedule oral opioid regimen equivalent to 60 to 1000 mg of oral morphine per day or transdermal fentanyl therapy equivalent to 50 to 300 µg/h, and are on a stable dose of opioid medication for relief of breakthrough pain.
Experiencing 1-4 episodes of breakthrough pain per day.
Meet the criteria defined in the Eastern Cooperative Oncology Group (ECOG) Performance Status for Grade 0, 1, or 2.

Key exclusion criteria (11 listed)

Have previously been exposed to EN3267.
Are pregnant or lactating.
Have uncontrolled or rapidly escalating pain.
Have any clinically significant condition that would, in the investigator's opinion, preclude participation in the study or compromise data collection. These conditions may include cardiopulmonary disease, and/or neurologic/psychologic conditions.
Are scheduled to take MAOIs (monoamine oxidase inhibitors) during the study.

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
EN3267Also: FentanylEN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses	Drug	sublingual fentanyl tablet

Primary outcome

Evaluate the Long-term Safety and Effectiveness of EN3267
Time frame: screening, 2 week titration period and 12 monthly study visits

Results and safety

Results posted to the registry on 19 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sublingual Fentanyl Tablet	139	96

Primary outcome: Evaluate the Long-term Safety and Effectiveness of EN3267

Time frame: screening, 2 week titration period and 12 monthly study visits. Number. Unit: participants

Measure	Titration n = 139	Maintenance n = 96	Overall n = 139
Patients with at least 1 AE	64	87	116
Patients with at least 1 AE causing discontinue	14	23	37
Patients with at least 1 SAE	7	40	46
Patients with an AE resulting in death	4	15	19

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sublingual Fentanyl Tablet	46 of 139 (33.1%)	116 of 139 (83.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21208151Nalamachu S, Hassman D, Wallace MS, Dumble S, Derrick R, Howell J. Long-term effectiveness and tolerability of sublingual fentanyl orally disintegrating tablet for the treatment of breakthrough cancer pain. Curr Med Res Opin. 2011 Mar;27(3):519-30. doi: 10.1185/03007995.2010.545380. Epub 2011 Jan 6.

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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.

Julian Howell study director

Kyowa Kirin Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EN3267 in people with Pain and Cancer, run by Kyowa Kirin Co., Ltd. at 1 site in United States.

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 5 inclusion and 11 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: finished, as of the sponsor's last update on 18 Jun 2024. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Evaluate the Long-term Safety and Effectiveness of EN3267 (time frame: screening, 2 week titration period and 12 monthly study visits). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00263575, which also lists 1 linked publication.

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 18 Jun 2024.