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| ID | Type | Description | Link |
|---|---|---|---|
| FENHYDPAI4014 | |||
| 2008-002074-35 |
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Stopped prematurely in 2008 due to IONSYS withdrawal off the market globally
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The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective spine or orthopedic (related to bones) surgery.
This is an open-label (participants and physicians are told which treatment the participants are receiving), multi-center (when more than one hospital or medical school team work on a medical research study), single-arm study of fentanyl ITS. The study will consist of 2 phases: screening phase and an open-label treatment phase. The duration of participation in the study for an individual participant will be 72 hours. All eligible participants (who require pain treatment with strong opioids [morphine like medications] for at least 48 hours after an elective spine or elective orthopedic surgery) will be treated with fentanyl ITS, delivering 40 microgram (mcg) fentanyl per on-demand dose, each deliver over 10 minutes for a maximum of 6 doses per hour (240 mcg per hour) for 24 hours or a maximum of 80 doses (3.2 milligram). Participants will be analyzed for the use of intravenous (giving a medicine directly into a vein) access during postoperative pain treatment with fentanyl ITS. Participant's safety will be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl ITS | Experimental | 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS). Total duration of treatment will be 72 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl ITS | Drug | 40 mcg per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an ITS. Total duration of treatment will be 72 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24 | Total number of participants who required intravenous administration (when medicine is given directly into a vein) postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed. | Hour 24 |
| Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at Hour 48 | Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed. | Hour 48 |
| Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at End of Study Treatment | Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed. | End of Study treatment (Hour 72) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control | The PGA was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the participants: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?" | Hour 72 or early withdrawal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag N.V./S.A., Belgium Clinical Trial | Janssen Cilag N.V./S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalst | Belgium | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Fentanyl ITS | Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS [a device which uses an electric current to move drug through the skin into the blood]), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Number of Participants With Nurse Global Assessment of Method of Pain Control | The nurse global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the nurses: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?" | Hour 72 or early withdrawal |
| Number of Participants With Physician Global Assessment of Method of Pain Control | The physician global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the Physicians: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?" | Hour 72 or early withdrawal |
| Brussels |
| Belgium |
| Edegem | Belgium |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fentanyl ITS | Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24 | Total number of participants who required intravenous administration (when medicine is given directly into a vein) postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed. | Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination. | Posted | Hour 24 |
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| Secondary | Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control | The PGA was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the participants: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?" | Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination. | Posted | Hour 72 or early withdrawal |
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| Secondary | Number of Participants With Nurse Global Assessment of Method of Pain Control | The nurse global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the nurses: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?" | Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination. | Posted | Hour 72 or early withdrawal |
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| Secondary | Number of Participants With Physician Global Assessment of Method of Pain Control | The physician global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the Physicians: "Overall, would you rate this method of pain control as being poor, fair, good, or excellent?" | Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination. | Posted | Hour 72 or early withdrawal |
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| Primary | Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at Hour 48 | Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed. | Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination. | Posted | Hour 48 |
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| Primary | Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at End of Study Treatment | Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed. | Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination. | Posted | End of Study treatment (Hour 72) |
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From start of study treatment upto Day 14
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fentanyl ITS | Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours. | 1 | 13 | 10 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peroneal nerve palsy (severe) | Nervous system disorders | MedDRA version 12.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 12.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA version 12.0 | Non-systematic Assessment |
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| Application site reaction | General disorders | MedDRA version 12.0 | Non-systematic Assessment |
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| Application site discolouration | General disorders | MedDRA version 12.0 | Non-systematic Assessment |
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| Application site swelling | General disorders | MedDRA version 12.0 | Non-systematic Assessment |
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| Application site pruritus (left side) | General disorders | MedDRA version 12.0 | Non-systematic Assessment |
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| Application site pruritus (right side) | General disorders | MedDRA version 12.0 | Non-systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA version 12.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 12.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 12.0 | Non-systematic Assessment |
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| Inadequate analgesia | Injury, poisoning and procedural complications | MedDRA version 12.0 | Non-systematic Assessment |
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| Peroneal nerve palsy (moderate) | Nervous system disorders | MedDRA version 12.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 12.0 | Non-systematic Assessment |
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| Urinary retension | Renal and urinary disorders | MedDRA version 12.0 | Non-systematic Assessment |
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| Application site reaction (left side) | General disorders | MedDRA version 12.0 | Non-systematic Assessment |
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| Application site reaction (right side) | General disorders | MedDRA version 12.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 12.0 | Non-systematic Assessment |
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No efficacy results were reported because the study was prematurely terminated, following the worldwide voluntary withdrawal of Fentanyl Iontophoretic Transdermal System (IONSYS) by Janssen-Cilag.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Responsible Physician | Janssen-Cilag Belgium | 003214649584 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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