Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients
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ClinicalTrials.gov Identifier: NCT00263575 |
Recruitment Status :
Completed
First Posted : December 9, 2005
Results First Posted : November 19, 2020
Last Update Posted : December 16, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain Cancer | Drug: EN3267 | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 139 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | December 2005 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | January 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: sublingual fentanyl tablet |
Drug: EN3267
EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses
Other Name: Fentanyl |
- Evaluate the Long-term Safety and Effectiveness of EN3267 [ Time Frame: screening, 2 week titration period and 12 monthly study visits ]

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Ages Eligible for Study: | 17 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263575
United States, North Carolina | |
Carolinas Pain Institute | |
Winston-Salem, North Carolina, United States, 27103 |
Study Director: | Julian Howell | Prostrakan Pharmaceuticals |
Responsible Party: | Prostrakan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00263575 |
Other Study ID Numbers: |
EN3267-007 |
First Posted: | December 9, 2005 Key Record Dates |
Results First Posted: | November 19, 2020 |
Last Update Posted: | December 16, 2020 |
Last Verified: | January 2014 |
EN3267 Breakthrough Pain Safety Study Fentanyl Tablets |
Breakthrough Pain Pain Neurologic Manifestations Fentanyl Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |