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| ID | Type | Description | Link |
|---|---|---|---|
| FENPAI 4053 |
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The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants with moderate (medium level of seriousness) to severe (very serious, life threatening) pain of osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-arm, prospective (study following participants forward in time), study of TTS-fentanyl in participants with moderate to severe pain of osteoarthritis. The study will consist of 2 phases: screening phase up to 7 days before starting the treatment and treatment phase of 30 days. The first patch will be applied by investigator then by participants until 30 days. The dose of TTS-fentanyl can be increased, if needed, by 12.5 microgram per hour until adequate (reasonably good) pain control is achieved and taking into account the daily dose of supplemental paracetamol required by the participant. Other concomitant (given at the same time) analgesics (drug used to control pain) will not be used during this phase. Efficacy with regard to pain control will be recorded principally by the participant through questionnaires in a daily diary. This record will be used to support more detailed assessments at study visits on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Participants' safety will be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transdermal Therapeutic System (TTS)-fentanyl | Experimental | TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTS-fentanyl | Drug | TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Score at Day 15 | The pain intensity was assessed by using a 10 centimeter (cm) Visual Analog Scale (VAS) ranging from 0 cm=no pain to 10 cm=worse pain. | Day 15 |
| Pain Intensity Score at Day 30 | The pain intensity was assessed by using a 10 cm VAS ranging from 0 cm=no pain to 10 cm=worse pain. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30 | The WOMAC is a self-administered; participant reported health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a VAS of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score of between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Ltd.,Thailand Clinical Trial | Janssen-Cilag Ltd.,Thailand | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangkok | Thailand |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transdermal Therapeutic System (TTS)-Fentanyl | TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Transdermal Therapeutic System (TTS)-Fentanyl | TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Pain Intensity Score at Day 15 | The pain intensity was assessed by using a 10 centimeter (cm) Visual Analog Scale (VAS) ranging from 0 cm=no pain to 10 cm=worse pain. | Intent to treat (ITT) population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. "N" signifies those participants who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | cm | Day 15 |
|
Baseline up to Day 30
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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 | Transdermal Therapeutic System (TTS)-Fentanyl | TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | General disorders | No coding applied | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Medical Affairs, Janssen-Cilag (Thailand) | 662-792-7200 | 5888 |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Baseline, Day 15 and Day 30 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pain Intensity Score by Visual Analog Scale (VAS) | Assessed by 10 cm of VAS from 0 to 10, where 0 cm=no pain and 10 cm=worse pain. | Mean | Standard Deviation | Centimeter [cm] |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Pain Intensity Score at Day 30 | The pain intensity was assessed by using a 10 cm VAS ranging from 0 cm=no pain to 10 cm=worse pain. | ITT population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. "N" signifies those participants who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | cm | Day 30 |
|
|
|
| Secondary | Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30 | The WOMAC is a self-administered; participant reported health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a VAS of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score of between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best. | ITT population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. "N" signifies those participants who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 15 and Day 30 |
|
|
|
| 0 |
| 35 |
| 23 |
| 35 |
| Nausea | General disorders | No coding applied | Non-systematic Assessment |
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| Constipation | General disorders | No coding applied | Non-systematic Assessment |
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| Abdominal pain | General disorders | No coding applied | Non-systematic Assessment |
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| Dyspepsia | General disorders | No coding applied | Non-systematic Assessment |
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| Drowsiness | General disorders | No coding applied | Non-systematic Assessment |
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| Headache | General disorders | No coding applied | Non-systematic Assessment |
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| Itching | General disorders | No coding applied | Non-systematic Assessment |
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| Irritate | General disorders | No coding applied | Non-systematic Assessment |
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| Fatigue | General disorders | No coding applied | Non-systematic Assessment |
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| Tinnitus | General disorders | No coding applied | Non-systematic Assessment |
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| Vertigo | General disorders | No coding applied | Non-systematic Assessment |
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| Lacrimation increased | General disorders | No coding applied | Non-systematic Assessment |
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| Dysphonia | General disorders | No coding applied | Non-systematic Assessment |
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If an Investigator wishes to publish information from the study, a copy of the manuscript must be provided to the Sponsor for review at least 60 days before submission for publication. If requested by the Sponsor, the Investigator will withhold it up to an additional 60 days to allow for filing of a patent application. The Sponsor will not change or suppress the scientific content. For multicenter study, results may not be published before the primary endpoints of a study have been published.
| Title | Measurements |
|---|---|
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