PainPhase 1NCT01173627
Bioequivalence of a Test Troche Formulation of Fentanyl Citrate (400 mcg) Compared to Actiq® 400 mcg, Cephalon, Inc.
A Phase 1 study testing Test fentanyl citrate 400 mcg troche and Actiq 400 mcg in people with Pain, run by Mallinckrodt at 1 site in United States.
Trial summary
The purpose of this study was to evaluate the oral bioequivalence of the Mallinckrodt test fentanyl citrate oral transmucosal 400 mcg troche compared to Actiq 400 mcg (Cephalon, Inc.) under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Test fentanyl citrate 400 mcg troche and Actiq 400 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Aug 2006
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or non-pregnant, non-lactating females, 18 years of age or older with a minimum body weight of 120 pounds and a body mass index (BMI) between 19 and 29 inclusive.
- Female subjects must be postmenopausal for at least one year, surgically sterile, or using a reliable method of contraception (oral, transdermal, or injectable hormonal contraceptive; condom with spermicide; IUD; abstinence, etc.) for at least 30 days prior to and for the duration of study participation.
- Normal, healthy status confirmed by required screening assessments.
- Subjects must be able to provide written consent and agree to abide by the study requirements.
- Subjects must be able to demonstrate they understand and can perform the dosing procedure correctly using a placebo troche at check-in to Period 1.
Who cannot join
- If female, a positive pregnancy test at any time during the study, pregnant, lactating, or likely to become pregnant during the study.
- Female subjects of childbearing potential who have not used adequate forms of birth control within 30 days of dosing.
- History of conditions that might contraindicate or require caution be used in the administration of fentanyl or naltrexone, including: renal impairment, hepatobiliary or pancreatic disease, gastrointestinal obstruction, cardiac disease, obstructive pulmonary disease, acute or severe bronchial asthma, hypercarbia, elevated intracranial pressure, depleted blood volume, paralytic ileus, or hypersensitivity or idiosyncratic reaction to fentanyl, naltrexone, or any opioids.
- History of any drug allergy, hypersensitivity, or intolerance which would compromise the safety of the subject or the study.
- History of chronic alcohol, drug, or narcotic abuse, chronic use of tranquilizers, sedatives, aspirin, antibiotics, or other medications.
- History of malignancy, stroke, or diabetes; cardiac, renal, liver, and pulmonary disease.
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- History of anxiety, tension, severe agitation, psychiatric disorders, psychosis, or mental depression requiring hospitalization, psychotherapy, and/or medication.
- History or diagnosis of epilepsy or other seizure disorder.
- History of abdominal and/or pelvic surgery within the last 5 years, except elective surgical sterilization.
- History of acute abdominal conditions or gastrointestinal disease including, but not limited to, peptic ulcer, diverticulitis, bowel obstructions, adhesions, ileus, gastritis, and chronic diarrhea.
- Subjects presenting with acute illness.
- Administration of any other investigational drug during the 30 days prior to study entry.
- Subjects who have smoked or used nicotine-containing products within 6 months prior to study entry.
- Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to study entry, including that withdrawn during the conduct of any other clinical study.
- Positive test results for HIV, hepatitis B, or hepatitis C.
- Positive test results for drugs of abuse or alcohol.
- Subjects who have taken prescription drugs, except hormonal contraception, within 14 days or over-the-counter medications (including herbal preparations) within 7 days prior to study drug administration except for standard daily dose multivitamins, which are excluded after check-in to Period 2.
- Any subject experiencing adverse events to the -13 and/or -1 hour doses of naltrexone, that in the investigator's opinion, are indicative of possible previous opioid use/abuse, or that would prevent tolerance of additional doses of naltrexone, will be withdrawn from the study prior to dosing with fentanyl.
- Subjects with dental braces or partial dentures.
- Subjects presenting with a history of gum disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Bioequivalence of an Oral Transmucosal Test Troche Formulation of Fentanyl Citrate (400 mcg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Actiq 400 mcg, Cephalon, Inc.) in Normal Human Subjects Under Fasting Conditions
The purpose of this study was to evaluate the oral bioequivalence of the Mallinckrodt test fentanyl citrate oral transmucosal 400 mcg troche compared to Actiq 400 mcg (Cephalon, Inc.) under fasting conditions.
Read the detailed description
Fentanyl is an opioid analgesic with pharmacological effects similar to morphine. Fentanyl interacts predominately with the opioid µ-receptor. In clinical settings, fentanyl exerts its principal pharmacologic effects on the central nervous system. The fentanyl citrate oral transmucosal troche, Actiq (Cephalon, Inc.), is indicated only for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to prior therapy for their underlying persistent cancer pain.
- Conditions
- Pain
- Being tested
- Test fentanyl citrate 400 mcg troche, Actiq 400 mcg
- Keywords
- Bioequivalence, Fentanyl
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test fentanyl citrate 400 mcg trocheDrug
Test fentanyl citrate 400 mcg troche administered as a single dose under fasted conditions
Actiq 400 mcgDrug
Actiq 400 mcg administered as a single dose under fasted conditions
| Study group | Role | What they receive |
|---|---|---|
| A - Test fentanyl citrate 400 mcg troche | Experimental | Test fentanyl citrate 400 mcg troche Receives: Drug: Test fentanyl citrate 400 mcg troche |
| B - Actiq 400 mcg | Active comparator | Actiq 400 mcg Receives: Drug: Actiq 400 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average bioequivalence is established if the 90% confidence interval on the ratio of formulation averages for AUCt, AUCinf, and Cmax are contained in the interval [80%, 125%].
Measured: 30 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startAug 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Herbert Neuman, MD, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173627
- Sponsor's protocol ID
- 9204-06-840
- Status last verified
- Oct 2016
- First submitted
- 29 Jul 2010
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Bioequivalence of an Oral Transmucosal Test Troche Formulation of Fentanyl Citrate (400 mcg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Actiq 400 mcg, Cephalon, Inc.) in Normal Human Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01173627
- Acronym / sponsor ID
- 9204-06-840
- Conditions
- Pain
- Keywords
- Bioequivalence, Fentanyl
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 2 Aug 2010 (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 was to evaluate the oral bioequivalence of the Mallinckrodt test fentanyl citrate oral transmucosal 400 mcg troche compared to Actiq 400 mcg (Cephalon, Inc.) under fasting conditions.
Detailed description
Fentanyl is an opioid analgesic with pharmacological effects similar to morphine. Fentanyl interacts predominately with the opioid µ-receptor. In clinical settings, fentanyl exerts its principal pharmacologic effects on the central nervous system. The fentanyl citrate oral transmucosal troche, Actiq (Cephalon, Inc.), is indicated only for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to prior therapy for their underlying persistent cancer pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - Test fentanyl citrate 400 mcg troche | Experimental | Drug: Test fentanyl citrate 400 mcg trocheTest fentanyl citrate 400 mcg troche |
| B - Actiq 400 mcg | Active comparator | Drug: Actiq 400 mcgActiq 400 mcg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or non-pregnant, non-lactating females, 18 years of age or older with a minimum body weight of 120 pounds and a body mass index (BMI) between 19 and 29 inclusive.
- Female subjects must be postmenopausal for at least one year, surgically sterile, or using a reliable method of contraception (oral, transdermal, or injectable hormonal contraceptive; condom with spermicide; IUD; abstinence, etc.) for at least 30 days prior to and for the duration of study participation.
- Normal, healthy status confirmed by required screening assessments.
- Subjects must be able to provide written consent and agree to abide by the study requirements.
- Subjects must be able to demonstrate they understand and can perform the dosing procedure correctly using a placebo troche at check-in to Period 1.
Key exclusion criteria (20 listed)
- If female, a positive pregnancy test at any time during the study, pregnant, lactating, or likely to become pregnant during the study.
- Female subjects of childbearing potential who have not used adequate forms of birth control within 30 days of dosing.
- History of conditions that might contraindicate or require caution be used in the administration of fentanyl or naltrexone, including: renal impairment, hepatobiliary or pancreatic disease, gastrointestinal obstruction, cardiac disease, obstructive pulmonary disease, acute or severe bronchial asthma, hypercarbia, elevated intracranial pressure, depleted blood volume, paralytic ileus, or hypersensitivity or idiosyncratic reaction to fentanyl, naltrexone, or any opioids.
- History of any drug allergy, hypersensitivity, or intolerance which would compromise the safety of the subject or the study.
- History of chronic alcohol, drug, or narcotic abuse, chronic use of tranquilizers, sedatives, aspirin, antibiotics, or other medications.
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 |
|---|---|---|
| Test fentanyl citrate 400 mcg trocheTest fentanyl citrate 400 mcg troche administered as a single dose under fasted conditions | Drug | A - Test fentanyl citrate 400 mcg troche |
| Actiq 400 mcgActiq 400 mcg administered as a single dose under fasted conditions | Drug | B - Actiq 400 mcg |
Primary outcome
Average bioequivalence is established if the 90% confidence interval on the ratio of formulation averages for AUCt, AUCinf, and Cmax are contained in the interval [80%, 125%].
Time frame: 30 hours
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 19 Oct 2016.
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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.
Herbert Neuman, MD study director
Mallinckrodt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test fentanyl citrate 400 mcg troche and Actiq 400 mcg in people with Pain, run by Mallinckrodt 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 20 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 19 Oct 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Average bioequivalence is established if the 90% confidence interval on the ratio of formulation averages for AUCt, AUCinf, and Cmax are contained in the interval [80%, 125%]. (time frame: 30 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2016.