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| ID | Type | Description | Link |
|---|---|---|---|
| FENPAI4074 |
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The purpose of this study is to evaluate the efficacy and safety of fentanyl among Filipino participants with osteoarthritis (disorder which is seen mostly in older persons in which the joints become painful and stiff) and chronic (lasting a long time) low back pain.
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 and prospective study (study following participants forward in time) of fentanyl in participants with osteoarthritis and Chronic low back pain with moderate (medium level of seriousness) and severe (very serious, life threatening) pain levels. Participants will be treated with fentanyl transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) starting with 12.5 microgram (mcg) dose of fentanyl. The dose will be increased on Day 3, if needed, by 12.5 mcg. Dose adjustments will be done every 3 days. Maximum of 50 mcg dose of fentanyl will be allowed. Participants will be evaluated for pain levels and quality of life using Brief pain inventory (BPI) score and Clinical global impression-severity (CGI-S) score. Tramadol 50 milligram tablet at a maximum of 6 tablets per day will be used as supplemental doses of analgesic (drug used to control pain). Participants' safety will be monitored through out the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl transdermal patch | Experimental | Fentanyl transdermal patches releasing 12.5 microgram of fentanyl will be applied for 3 days. The patches will be replaced every 3 days (Day 3, 7 and 10). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | Fentanyl transdermal patches releasing 12.5 microgram of fentanyl will be applied for 3 days. The patches will be replaced every 3 days (Day 3, 7 and 10). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 | BPI is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI- severity consists of 4 questions (items) that assess pain intensity (worst, least, average, right now). Each question (item) is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Change: Score at Day 30 minus score at Baseline. | Baseline and Day 30 |
| Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | BPI is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-interference consists of 7 questions (items) that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question (item) is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Change: Score at Day 30 minus score at Baseline. | Baseline and Day 30 |
| Number of Participants Requiring Rescue Medication | Rescue medications are periodic supplemental doses of analgesic which might be required to control pain. Tramadol 50mg tablet at a maximum of 6 tablets per day was used as standard rescue medication. | Day 30 |
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician | CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutica Clinical trial | Janssen Pharmaceutica | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quezon City | Philippines |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fentanyl | Fentanyl transdermal (through the skin) patches releasing 12.5 microgram (mcg) of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fentanyl | Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg. |
| 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 | Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 | BPI is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI- severity consists of 4 questions (items) that assess pain intensity (worst, least, average, right now). Each question (item) is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Change: Score at Day 30 minus score at Baseline. | The intent-to-treat (ITT) population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Day 30 |
|
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 | Fentanyl | Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Manager | Janssen Philippines | +632-8247901 |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Day 30 |
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant | CGI-I is a 7-point scale that requires the Participant to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. | Day 30 |
| Diagnosed with metastasis |
|
| No pain |
|
| Death |
|
| Withdrew consent & had adverse events |
|
| Physician Decision |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician | CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Here, 'N' signifies the participants analyzed for this study specific Baseline characteristic and is Intent-to-treat population defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment=203. | Number | Participants |
|
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant | CGI-I is a 7-point scale that requires the participant to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Number of participants analysed for this study specific Baseline characteristic=203. | Number | Participant |
|
|
|
| Primary | Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | BPI is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-interference consists of 7 questions (items) that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question (item) is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Change: Score at Day 30 minus score at Baseline. | The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Day 30 |
|
|
|
| Primary | Number of Participants Requiring Rescue Medication | Rescue medications are periodic supplemental doses of analgesic which might be required to control pain. Tramadol 50mg tablet at a maximum of 6 tablets per day was used as standard rescue medication. | All participants suffering from osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stuff) and chronic (lasting a long time) low back pain and who took at least 1 dose of study medication and had at least 1 follow-up visit during the study. | Posted | Number | Participants | Day 30 |
|
|
|
| Primary | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician | CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. | The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment. | Posted | Number | Participants | Day 30 |
|
|
|
| Primary | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant | CGI-I is a 7-point scale that requires the Participant to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. | The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment. | Posted | Number | Participants | Day 30 |
|
|
|
| 5 |
| 237 |
| 156 |
| 237 |
| Aneurysm ruptured | Vascular disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| Erythema nodosum | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Vomiting | General disorders | Non-systematic Assessment |
|
| Somnolence | General disorders | Non-systematic Assessment |
|
| Pruritus | General disorders | Non-systematic Assessment |
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| Insomnia | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Palpitation | General disorders | Non-systematic Assessment |
|
| Rashes | General disorders | Non-systematic Assessment |
|
| Weakness | General disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Cold clammy perspiration | General disorders | Non-systematic Assessment |
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| Flushing | General disorders | Non-systematic Assessment |
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| Muscle trembling | General disorders | Non-systematic Assessment |
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| Arm heaviness | General disorders | Non-systematic Assessment |
|
| Blurring of vision | General disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
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| Constipation | General disorders | Non-systematic Assessment |
|
| Dryness of mouth | General disorders | Non-systematic Assessment |
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| Dyspepsia | General disorders | Non-systematic Assessment |
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| Hematoma | General disorders | Non-systematic Assessment |
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| Hypertension | General disorders | Non-systematic Assessment |
|
| Swelling of both ankles | General disorders | Non-systematic Assessment |
|
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| D001416 |
| Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Baseline: Normal work |
|
| Baseline: Relationship w/others |
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| Baseline: Sleep |
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| Baseline: Enjoyment of life |
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| Change at Day 30: General activity |
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| Change at Day 30: Mood |
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| Change at Day 30: Walking ability |
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| Change at Day 30: Normal work |
|
| Change at Day 30: Relationship w/others |
|
| Change at Day 30: Sleep |
|
| Change at Day 30: Enjoyment of life |
|
| Title | Measurements |
|---|---|
|
| Much improved |
|
| Very Much improved |
|
| Title | Measurements |
|---|---|
|
| Minimally improved |
|
| Much improved |
|
| Very Much improved |
|