A Phase 3 interventional study of EN3267 in Pain and Cancer, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in United States. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2024-06-18.
Sponsored by Kyowa Kirin Co., Ltd. · Phase 3, Interventional, and Treatment
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.
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:
34 studies on the registry are indexed under Breakthrough Pain; 4 are open to participants now.
This study's enrollment of 139 is above the median of 91 across 21 interventional studies indexed under Breakthrough Pain.
Browse Breakthrough Pain studies →Kyowa Kirin Co., Ltd. is the lead sponsor of 159 studies on the registry; 8 are open to participants now.
Compared within Breakthrough Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pain. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: EN3267
EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses
Also known as: Fentanyl
Evaluate the Long-term Safety and Effectiveness of EN3267
Time frame: screening, 2 week titration period and 12 monthly study visits
Recruitment period was first patient screened in December 2005 to last patient screened in November 2008. Patients were recruited from Medical Institutions in the US.
| Milestone | Sublingual Fentanyl Tablet |
|---|---|
| Started | 139 |
| Completed | 96 |
| Not completed | 43 |
| Withdrew: Adverse event | 14 |
| Withdrew: Withdrawal by subject | 10 |
| Withdrew: Protocol violation | 9 |
| Withdrew: Sponsor decision | 2 |
| Withdrew: Other | 2 |
| Withdrew: Lack of efficacy | 6 |
| Milestone | Sublingual Fentanyl Tablet |
|---|---|
| Started | 96 |
| Completed | 19 |
| Not completed | 77 |
| Withdrew: Adverse event | 23 |
| Withdrew: Withdrawal by subject | 8 |
| Withdrew: Protocol violation | 4 |
| Withdrew: Lack of efficacy | 4 |
| Withdrew: Physician decision | 6 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Sponsor decision | 24 |
| Withdrew: Other | 7 |
| participants | Titration | Maintenance | Overall |
|---|---|---|---|
| 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 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sublingual Fentanyl Tablet | — | 46/139 (33.1%) | 116/139 (83.5%) |
| Event | Sublingual Fentanyl Tablet |
|---|---|
| deathGeneral disorders | 19/139 |
| DehydrationMetabolism and nutrition disorders | 6/139 |
| Prostate cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 5/139 |
| AnemiaBlood and lymphatic system disorders | 3/139 |
| Febrile neutropeniaBlood and lymphatic system disorders | 3/139 |
| PainGeneral disorders | 3/139 |
| Breast cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/139 |
| Colon cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/139 |
| Lung cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/139 |
| Metastatic carcinoma of the bladderNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/139 |
| Event | Sublingual Fentanyl Tablet |
|---|---|
| NauseaGastrointestinal disorders | 32/139 |
| FatigueGeneral disorders | 21/139 |
| VomitingGastrointestinal disorders | 18/139 |
| DehydrationMetabolism and nutrition disorders | 16/139 |
| Edema peripheralGeneral disorders | 15/139 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 14/139 |
| Back painMusculoskeletal and connective tissue disorders | 13/139 |
| InsomniaPsychiatric disorders | 13/139 |
| ConstipationGastrointestinal disorders | 12/139 |
| AstheniaGeneral disorders | 12/139 |
| Age, Categorical(Participants) | Sublingual Fentanyl Tablet |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 106 |
| >=65 years | 33 |
| Age, Continuous(years) | Sublingual Fentanyl Tablet |
|---|---|
| Mean | 57 ± 11.6 |
| Sex: Female, Male(Participants) | Sublingual Fentanyl Tablet |
|---|---|
| Female | 76 |
| Male | 63 |
| Region of Enrollment(participants) | Sublingual Fentanyl Tablet |
|---|---|
| United States | 139 |
The record gives a start of Dec 2005, a primary completion of Dec 2008 and a completion of Jan 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2020, 11 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fentanyl