PainPhase 3NCT00262678
Efficacy and Safety of Sublingual Fentanyl Tablets in Treatment of Breakthrough Pain 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.
Trial summary
The purpose of this study is to determine the effectiveness and safety of sublingual fentanyl tablets in relieving breakthrough pain in cancer patients. Read more about this study
- Who is it for?
- Ages 17 years and older
- What is being tested?
- EN3267
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jan 2009
- Phase
- Phase 3
- 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 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 for at least 14 days prior to screening.
- 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
- Are pregnant or lactating.
- Have uncontrolled or rapidly escalating pain.
- Have moderate to severe ulcerative mucositis.
- Have a cardiopulmonary disease that would increase the risk of administering potent opioids.
- Have neurologic or psychologic disease that would compromise data collection
- Have any clinically significant condition that would, in the investigator's opinion, preclude study participation.
Show all 13Show fewer
- Are currently taking monoamine oxidase inhibitors (MAOIs), or have taken MAOIs within 14 days prior to enrolling in the study.
- Have received strontium 89 therapy within 60 days prior to entering the study.
- Have received anti-neoplastic therapy within 2 weeks of study entry that, in the investigator's opinion, will influence assessment of breakthrough pain
- Have received any investigational drug (non-approved) within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than EN3267 during the course of the study.
- Have hypersensitivities, allergies, or contraindications to fentanyl.
- Have a significant prior history of substance abuse or alcohol abuse.
- May have difficulty complying with the protocol, as assessed by the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Pain Institute
Winston-Salem, North Carolina, 27103
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of EN3267 for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients.
The purpose of this study is to determine the effectiveness and safety of sublingual fentanyl tablets in relieving breakthrough pain in cancer patients.
- Being tested
- EN3267
- Medical subject headings
- Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EN3267Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262678
- Sponsor's protocol ID
- EN3267-005
- Status last verified
- Jun 2009
- First submitted
- 6 Dec 2005
- Last updated
- 4 Jun 2009
- Results posted
- No
Publications
Rauck RL, Tark M, Reyes E, Hayes TG, Bartkowiak AJ, Hassman D, Nalamachu S, Derrick R, Howell J. Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain. Curr Med Res Opin. 2009 Dec;25(12):2877-85. doi: 10.1185/03007990903368310.
PubMed 19814586
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of EN3267 for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients.
- ClinicalTrials.gov ID
- NCT00262678
- Acronym / sponsor ID
- EN3267-005
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- 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
- 7 Dec 2005 (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 determine the effectiveness and safety of sublingual fentanyl tablets in relieving breakthrough pain in cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
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 for at least 14 days prior to screening.
- 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 (13 listed)
- Are pregnant or lactating.
- Have uncontrolled or rapidly escalating pain.
- Have moderate to severe ulcerative mucositis.
- Have a cardiopulmonary disease that would increase the risk of administering potent opioids.
- Have neurologic or psychologic disease that would compromise data collection
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 |
|---|---|---|
| EN3267 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2009.
- Derived from this study: PubMed 19814586Rauck RL, Tark M, Reyes E, Hayes TG, Bartkowiak AJ, Hassman D, Nalamachu S, Derrick R, Howell J. Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain. Curr Med Res Opin. 2009 Dec;25(12):2877-85. doi: 10.1185/03007990903368310.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
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 13 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 4 Jun 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00262678, 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 4 Jun 2009.