A Phase 3 interventional study of Fentanyl Buccal Tablets in Pain, Chronic Pain and Breakthrough Pain, sponsored by Cephalon. Terminated at 33 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-10-22.
Sponsored by Cephalon (part of Teva Pharmaceutical Industries, Ltd.) · Phase 3, Interventional, and Treatment
The primary purpose of the study is to evaluate the impact of treatment with fentanyl buccal tablets on the anxiety symptoms commonly associated with chronic pain in patients with breakthrough pain (BTP). Other purposes are to assess the management of BTP, to evaluate patient functioning, and to determine any influences on the successful dose achieved.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 218 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Cephalon is the lead sponsor of 75 studies on the registry; none are open to participants now.
First submitted before Cephalon became part of Teva Pharmaceutical Industries, Ltd..
Counted across the registry records on this site, refreshed daily.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
Drug: Fentanyl Buccal Tablets
Fentanyl buccal tablets (FBT) placed in the buccal cavity above a rear molar until disintegrated, approximately 14-25 minutes. Dose titration: Participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg as needed. For each breakthrough pain (BTP) episode, participants took a dose, and did not take further study drug if adequate pain relief was achieved. If pain was not controlled within 30 minutes, the same dose level was repeated. If pain relief was inadequate 30 minutes after the second dose, usual rescue medication was taken for that BTP episode. Doses were adjusted until pain relief was adequate and side effects were tolerated. Open-label: Once the successful dose of FBT was identified (100, 200, 400, 600, or 800 mcg), participants were dispensed a 4-week supply at the successful dose. Participants were not to use FBT for more than 6 BTP episodes or take more than 8 FBT daily.
Also known as: Fentora, CEP-25608, Fentanyl citrate
Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Total Score at Approximately Week 5
The change from baseline to approximately week 5 in the PASS total score. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. The total score has a range of 0-200.
Time frame: Day 0 (baseline), approximately week 5
Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Subscale Scores at Approximately Week 5
The change from baseline to approximately week 5 in the PASS subscale scores. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. Those 40 questions are organized into four subscales: fear, cognitive anxiety, somatic anxiety, and escape/avoidance. Each subscale score is obtained by summing the answers to the ten items in the subscore resulting in a range of 0-50.
Time frame: Day 0 (baseline), approximately week 5
Change From Baseline in the Beck Depression Inventory at Approximately Week 5
Change from baseline to endpoint (week 4 of Treatment period or last post baseline visit) in the Beck Depression Inventory (BDI). The BDI is a self-reporting instrument that asks 21 questions regarding how the participant felt in the past few days. Answers are in sentence form, and offer a scale where the first answer (worth 0 points) indicates no depression and the fourth answer (worth 3 points) indicates significant depression. Totals (0-63) are grouped so that totals of 1-10 are interpreted as 'These ups and downs are considered normal' and scores \>40 indicate extreme depression.
Time frame: Day 0 (baseline), approximately week 5
Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5
Change from baseline to endpoint (week 4 of Treatment period or last post baseline visit) in the Multidimensional Pain Inventory Subscales. Answers to questions in the MPI are captured on a 7-point scale, with 0=most positive answer and 6= least positive answer. Twenty questions focus on pain, fourteen on a significant other's response when participant is in pain, and eighteen questions about daily activities. There are a total of 13 subscales with variable ranges. Subscales and corresponding ranges are listed in the results table. The General Activity category combines the Household Chores, Outdoor Work, Activities Away from Home, and Social Activities categories.
Time frame: Day 0 (baseline), approximately week 5
Medication Preference From the Pain Flare Treatment Satisfaction Questionnaire at Approximately Week 5
The summary question from the Pain Flare Treatment Satisfaction Questionnaire asked participants which medication they preferred to use for their break-through pain. Options were 1) Prior medication 2) Study medication 3) no preference
Time frame: approximately week 5
Patient Assessment of Ability to Go to Work at Approximately Week 5
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to go to work.
Time frame: approximately week 5
Patient Assessment of Ability to Perform at Work at Approximately Week 5
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to perform at work and includes both work outside the home and housework.
Time frame: approximately week 5
Patient Assessment of Ability to Walk at Approximately Week 5
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to walk.
Time frame: approximately week 5
Patient Assessment of Ability to Exercise at Approximately Week 5
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to exercise.
Time frame: approximately week 5
Patient Assessment of Ability to Participate in Social Events at Approximately Week 5
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to participate in social events.
Time frame: approximately week 5
Patient Assessment of Ability to Have Sex at Approximately Week 5
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to have sex.
Time frame: approximately week 5
Patient Assessment of Ability to Enjoy Life at Approximately Week 5
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to enjoy life.
Time frame: approximately week 5
Clinical Assessment of Patient Function - General Activities - at Approximately Week 5
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's general activities.
Time frame: approximately week 5
Clinical Assessment of Patient Function - Patient's Walking Ability - at Approximately Week 5
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's walking ability.
Time frame: approximately week 5
Clinical Assessment of Patient Function - Patient's Ability to Work/Perform Activities of Daily Living - at Approximately Week 5
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's ability to work and perform activities of daily living.
Time frame: approximately week 5
Clinical Assessment of Patient Function - Patient's Relationship With Others - at Approximately Week 5
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's relationship with others.
Time frame: approximately week 5
Clinical Assessment of Patient Function - Patient's Enjoyment of Life - at Approximately Week 5
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's enjoyment of life.
Time frame: approximately week 5
Summary of Participants' Successful Dosing Levels of Fentanyl Buccal Tablets to Control Episodes of Breakthrough Pain (BTP)
During the dose titration period, participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg if needed. For each breakthrough pain (BTP) episode, participants took a dose, and did not take further study drug if adequate pain relief was achieved. If pain was not controlled within 30 minutes, the same dose level was repeated. If pain relief was inadequate 30 minutes after the second dose, usual rescue medication was taken for that BTP episode. Doses were adjusted until pain relief was adequate and side effects were tolerated. This outcome summarizes the successful dose levels identified during the titration period.
Time frame: up to 10 days
A total of 327 patients with chronic pain and breakthrough pain (BTP) were screened for enrollment into this study. Of the 327 patients screened, 218 patients at 31 centers in the US met entry criteria and were considered eligible for enrollment into the study.
| Milestone | Fentanyl Buccal Tablets |
|---|---|
| Started | 218 |
| Completed | 180 |
| Not completed | 38 |
| Withdrew: Adverse event | 12 |
| Withdrew: Lack of efficacy | 5 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Noncompliance with study medication | 8 |
| Withdrew: Noncompliance with study procedures | 7 |
| Milestone | Fentanyl Buccal Tablets |
|---|---|
| Started | 180 |
| Full analysis set | 175 |
| Completed | 169 |
| Not completed | 11 |
| Withdrew: Adverse event | 4 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Noncompliance with study medication | 2 |
| Withdrew: Noncompliance with study procedures | 3 |
| Withdrew: Participant reported study drug stolen | 1 |
The change from baseline to approximately week 5 in the PASS total score. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. The total score has a range of 0-200.
| units on a scale | Fentanyl Buccal Tablets |
|---|---|
| Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Total Score at Approximately Week 5 | -1.6 ± 20.71 |
The change from baseline to approximately week 5 in the PASS subscale scores. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. Those 40 questions are organized into four subscales: fear, cognitive anxiety, somatic anxiety, and escape/avoidance. Each subscale score is obtained by summing the answers to the ten items in the subscore resulting in a range of 0-50.
| units on a scale | Fentanyl Buccal Tablets |
|---|---|
| Fear | -0.5 ± 6.14 |
| Cognitive anxiety | -1.1 ± 7.20 |
| Somatic anxiety | 0.4 ± 7.39 |
| Escape/avoidance | -0.4 ± 5.87 |
Change from baseline to endpoint (week 4 of Treatment period or last post baseline visit) in the Beck Depression Inventory (BDI). The BDI is a self-reporting instrument that asks 21 questions regarding how the participant felt in the past few days. Answers are in sentence form, and offer a scale where the first answer (worth 0 points) indicates no depression and the fourth answer (worth 3 points) indicates significant depression. Totals (0-63) are grouped so that totals of 1-10 are interpreted as 'These ups and downs are considered normal' and scores \>40 indicate extreme depression.
| units on a scale | Fentanyl Buccal Tablets |
|---|---|
| Change From Baseline in the Beck Depression Inventory at Approximately Week 5 | -1.1 ± 6.98 |
Change from baseline to endpoint (week 4 of Treatment period or last post baseline visit) in the Multidimensional Pain Inventory Subscales. Answers to questions in the MPI are captured on a 7-point scale, with 0=most positive answer and 6= least positive answer. Twenty questions focus on pain, fourteen on a significant other's response when participant is in pain, and eighteen questions about daily activities. There are a total of 13 subscales with variable ranges. Subscales and corresponding ranges are listed in the results table. The General Activity category combines the Household Chores, Outdoor Work, Activities Away from Home, and Social Activities categories.
| units on a scale | Fentanyl Buccal Tablets |
|---|---|
| Interference (0-54) | -0.2 ± 0.90 |
| Support (0-18) | -0.0 ± 1.02 |
| Pain Severity (0-18) | -0.3 ± 0.97 |
| Life-Control (0-12) | 0.1 ± 1.25 |
| Affective Distress (0-18) | -0.1 ± 1.24 |
| Negative Responses (0-24) | -0.1 ± 1.01 |
| Solicitous Responses (0-24) | 0.1 ± 1.03 |
| Distracting Responses (0-36) | 0.2 ± 1.02 |
| Household Chores (0-30) | 0.1 ± 1.05 |
| Outdoor Work (0-30) | -0.0 ± 0.74 |
| Activities Away from Home (0-24) | 0.1 ± 0.87 |
| Social Activities (0-24) | 0.0 ± 0.86 |
| General Activity (0-108) | 0.0 ± 0.67 |
The summary question from the Pain Flare Treatment Satisfaction Questionnaire asked participants which medication they preferred to use for their break-through pain. Options were 1) Prior medication 2) Study medication 3) no preference
| participants | Fentanyl Buccal Tablets |
|---|---|
| Prior medication | 38 |
| Study medication | 115 |
| No preference | 21 |
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to go to work.
| participants | Fentanyl Buccal Tablets |
|---|---|
| Very much worsened | 2 |
| Much worsened | 0 |
| Slightly worsened | 2 |
| Unchanged | 51 |
| Slightly improved | 14 |
| Much improved | 13 |
| Very much improved | 6 |
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to perform at work and includes both work outside the home and housework.
| participants | Fentanyl Buccal Tablets |
|---|---|
| Very much worsened | 4 |
| Much worsened | 1 |
| Slightly worsened | 6 |
| Unchanged | 69 |
| Slightly improved | 41 |
| Much improved | 45 |
| Very much improved | 9 |
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to walk.
| participants | Fentanyl Buccal Tablets |
|---|---|
| Very much worsened | 3 |
| Much worsened | 1 |
| Slightly worsened | 5 |
| Unchanged | 76 |
| Slightly improved | 42 |
| Much improved | 36 |
| Very much improved | 11 |
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to exercise.
| participants | Fentanyl Buccal Tablets |
|---|---|
| Very much worsened | 3 |
| Much worsened | 1 |
| Slightly worsened | 5 |
| Unchanged | 90 |
| Slightly improved | 46 |
| Much improved | 21 |
| Very much improved | 9 |
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to participate in social events.
| participants | Fentanyl Buccal Tablets |
|---|---|
| Very much worsened | 1 |
| Much worsened | 3 |
| Slightly worsened | 6 |
| Unchanged | 80 |
| Slightly improved | 46 |
| Much improved | 34 |
| Very much improved | 5 |
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to have sex.
| participants | Fentanyl Buccal Tablets |
|---|---|
| Very much worsened | 4 |
| Much worsened | 2 |
| Slightly worsened | 3 |
| Unchanged | 129 |
| Slightly improved | 18 |
| Much improved | 12 |
| Very much improved | 5 |
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to enjoy life.
| participants | Fentanyl Buccal Tablets |
|---|---|
| Very much worsened | 2 |
| Much worsened | 1 |
| Slightly worsened | 6 |
| Unchanged | 66 |
| Slightly improved | 48 |
| Much improved | 38 |
| Very much improved | 14 |
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's general activities.
| participants | Fentanyl Buccal Tablets |
|---|---|
| Very much worsened | 0 |
| Much worsened | 1 |
| Slightly worsened | 4 |
| Unchanged | 58 |
| Slightly improved | 57 |
| Much improved | 46 |
| Very much improved | 9 |
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's walking ability.
| participants | Fentanyl Buccal Tablets |
|---|---|
| Very much worsened | 0 |
| Much worsened | 0 |
| Slightly worsened | 4 |
| Unchanged | 81 |
| Slightly improved | 48 |
| Much improved | 31 |
| Very much improved | 10 |
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's ability to work and perform activities of daily living.
| participants | Fentanyl Buccal Tablets |
|---|---|
| Very much worsened | 0 |
| Much worsened | 1 |
| Slightly worsened | 5 |
| Unchanged | 63 |
| Slightly improved | 55 |
| Much improved | 39 |
| Very much improved | 12 |
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's relationship with others.
| participants | Fentanyl Buccal Tablets |
|---|---|
| Very much worsened | 0 |
| Much worsened | 0 |
| Slightly worsened | 1 |
| Unchanged | 98 |
| Slightly improved | 35 |
| Much improved | 32 |
| Very much improved | 9 |
At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's enjoyment of life.
| participants | Fentanyl Buccal Tablets |
|---|---|
| Very much worsened | 0 |
| Much worsened | 2 |
| Slightly worsened | 1 |
| Unchanged | 69 |
| Slightly improved | 45 |
| Much improved | 43 |
| Very much improved | 15 |
During the dose titration period, participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg if needed. For each breakthrough pain (BTP) episode, participants took a dose, and did not take further study drug if adequate pain relief was achieved. If pain was not controlled within 30 minutes, the same dose level was repeated. If pain relief was inadequate 30 minutes after the second dose, usual rescue medication was taken for that BTP episode. Doses were adjusted until pain relief was adequate and side effects were tolerated. This outcome summarizes the successful dose levels identified during the titration period.
| participants | Fentanyl Buccal Tablets |
|---|---|
| 100 mcg | 18 |
| 200 mcg | 49 |
| 400 mcg | 41 |
| 600 mcg | 31 |
| 800 mcg | 41 |
| None (no successful dose) | 38 |
Collected over Treatment emergent adverse events: Day 1 to approximately 5 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fentanyl Buccal Tablets | — | 4/218 (1.8%) | 21/218 (9.6%) |
| Event | Fentanyl Buccal Tablets |
|---|---|
| BronchitisInfections and infestations | 1/218 |
| Radius fractureInjury, poisoning and procedural complications | 1/218 |
| Diabetic ketoacidosisMetabolism and nutrition disorders | 1/218 |
| Suicide attemptPsychiatric disorders | 1/218 |
| Event | Fentanyl Buccal Tablets |
|---|---|
| NauseaGastrointestinal disorders | 21/218 |
| Age Continuous(years) | Fentanyl Buccal Tablets |
|---|---|
| Mean | 49.9 ± 11.03 |
| Sex: Female, Male(Participants) | Fentanyl Buccal Tablets |
|---|---|
| Female | 124 |
| Male | 94 |
| Ethnicity (NIH/OMB)(Participants) | Fentanyl Buccal Tablets |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 203 |
| Unknown or Not Reported | 11 |
| Race/Ethnicity, Customized(participants) | Fentanyl Buccal Tablets |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 208 |
| Unknown or Not Reported | 1 |
| Primary chronic painful condition(participants) | Fentanyl Buccal Tablets |
|---|---|
| Back pain | 136 |
| Neck pain | 14 |
| Fibromyalgia | 13 |
| Traumatic injury | 12 |
| Osteoarthritis | 11 |
| Complex regional pain syndrome | 9 |
| Diabetic peripheral neuropathy | 3 |
| Cancer | 3 |
| Chronic pancreatitis | 2 |
| Other | 15 |
This study is terminated, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fentanyl