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| ID | Type | Description | Link |
|---|---|---|---|
| DURO-THAI-3 |
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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 Thai participants with chronic (lasting a long time) non-malignant (non-cancerous) pain.
This is an open label (all people know the identity of the intervention), single arm study to assess the efficacy and safety of TTS-fentanyl in Thai participants with chronic non-malignant pain (except for headaches or central spinal cord mediated pain). The study will consist of 2 phases: stabilization phase (up to 7 days before starting the treatment) and treatment phase (30 days). The first patch will be applied by Investigator then by participants themselves until 30 days. All participants will start the treatment with patch releasing 25 micrograms per hour (mcg/h) of fentanyl . The patches will be replaced every 3 days. On Day 3, and every 3 days thereafter, the TTS-fentanyl dose can be titrated (slow increase in drug dosage, guided by participant's responses) as per participant's need. The duration of the treatment will be 30 days after first patch application. The dose of TTS-fentanyl can be slowly increased if needed, by 25 mcg/h to achieve adequate pain control. No increase in TTS-fentanyl dose will be performed within the 72-hour dosing interval. Participants will be allowed the use of oral morphine syrup for the duration of TTS-fentanyl treatment to enable appropriate TTS-fentanyl dose titration. Primary efficacy assessment will be pain control rated by participants. Assessment time points will be Day 0 (Baseline), Day 15 and Day 30 (trial end). At the end of study, global preference on efficacy, side effects and overall satisfaction will also be rated by Investigator and participants. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transdermal Therapeutic System (TTS)-fentanyl | Experimental | Transdermal Therapeutic System (TTS)-fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS will be calculated based on each participant's opioid requirement. Patches will be usually replaced every 72 hours. Doses will be escalated in steps of 25 mcg/hr, if pain cannot be controlled. Oral morphine syrup is allowed to titrate the dose of TTS-fentanyl. The study duration will be 30 days after first patch application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTS-Fentanyl | Drug | Transdermal Therapeutic System (TTS)-fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS will be calculated based on each participant's opioid requirement. Patches will be usually replaced every 72 hours. Doses will be escalated in steps of 25 mcg/hr, if pain cannot be controlled. The study duration will be 30 days after first patch application. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pain Intensity Rating at Day 15 | Pain intensity was assessed on 11-point Numeric Rating Scale (NRS); score ranges from 0 to 10 where 0=no pain and 10=worst pain. | Baseline and Day 15 |
| Change From Baseline in Pain Intensity Rating at Day 30 | Pain intensity was assessed on 11-point NRS; score ranges from 0 to 10 where 0=no pain and 10=worst pain. | Baseline and Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Investigator's Global Assessment | Investigator would complete a global assessment of the participants treatment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent (%) worse, 0=unchanged and 4=100% improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent). Number of participants with Investigator's assessment with respect to efficacy, safety and overall satisfaction were reported. |
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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 |
|---|---|---|---|---|---|---|
| Department of Anesthesia, Faculty of Medicine, Siriraj Hospital, Mahidol University | Bangkok | Thailand | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Transdermal Therapeutic System (TTS) - Fentanyl | Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant's opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The demographics was reported for only 38 participants who were eligible for the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Transdermal Therapeutic System (TTS) - Fentanyl | Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant's opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application. |
| 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 Pain Intensity Rating at Day 15 | Pain intensity was assessed on 11-point Numeric Rating Scale (NRS); score ranges from 0 to 10 where 0=no pain and 10=worst pain. | Intent-to-treat (ITT) population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Day 15 |
|
From first dose of study medication 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 | Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant's opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Septic shock | Infections and infestations | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flu-like symptom | General disorders | MedDRA | Non-systematic Assessment |
Some limitations of this study were non randomization and uncontrolled design.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Medical Affairs, Janssen-Cilag (Thailand) | 662-792-7200 |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
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|
|
| Morphine | Drug | Participants will be allowed the use of oral morphine syrup for the duration of TTS-fentanyl treatment to enable appropriate dose titration. It is expected that most of the participants will be titrated to an appropriate dose of TTS-fentanyl within 1 week. |
|
| Day 30 |
| Number of Participants With Participant's Global Assessment | Participants global assessment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100% worse, 0=unchanged and 4=100% improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent). Number of participants with participant's global assessment with respect to efficacy, safety and overall satisfaction were reported. | Day 30 |
| Bangkok |
| Thailand |
| Not eligible for the study |
|
| Amputation |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pain Intensity Rating | Pain intensity was assessed on 11-point Numeric Rating Scale (NRS); score ranges from 0 to 10, where 0=no pain and 10=worst pain. | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Change From Baseline in Pain Intensity Rating at Day 30 | Pain intensity was assessed on 11-point NRS; score ranges from 0 to 10 where 0=no pain and 10=worst pain. | The ITT population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Day 30 |
|
|
|
| Secondary | Number of Participants With Investigator's Global Assessment | Investigator would complete a global assessment of the participants treatment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent (%) worse, 0=unchanged and 4=100% improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent). Number of participants with Investigator's assessment with respect to efficacy, safety and overall satisfaction were reported. | The ITT population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | Participants | Day 30 |
|
|
|
| Secondary | Number of Participants With Participant's Global Assessment | Participants global assessment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100% worse, 0=unchanged and 4=100% improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent). Number of participants with participant's global assessment with respect to efficacy, safety and overall satisfaction were reported. | The ITT population set included all participants who received at least one dose of study drug and had at least one post-baseline efficacy assessment. 'N' (number of participants analyzed) = participants who were evaluable for this measure and 'n' = participants who were evaluable for this measure at given time points. | Posted | Number | Participants | Day 30 |
|
|
|
| 1 |
| 39 |
| 25 |
| 39 |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Palpitation | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Drowsiness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dullness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Nightmare | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Hypotension | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Peripheral neuropathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Angular ulcer | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Non pitting edema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
Timing and publication of the results will be subject to mutual agreement in the project between all Investigators participating in the project and Janssen-Cilag., Thailand.
All manuscripts and abstracts utilizing the data from this study are subjected to the approval of Janssen. All manuscripts and abstract must be sent to Janssen at least one month prior to the submission for publication or presentation.
| D009019 |
| Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
|---|---|
|
| Efficacy, 25% Worse |
|
| Efficacy, Unchanged |
|
| Efficacy, 25% Improve |
|
| Efficacy, 50% Improve |
|
| Efficacy, 75% Improve |
|
| Efficacy, 100% Improve |
|
| Safety, No |
|
| Safety, Mild |
|
| Safety, Moderate |
|
| Safety, Severe |
|
| Safety, Most severe |
|
| Overall Satisfaction, No |
|
| Overall Satisfaction, Mild |
|
| Overall Satisfaction, Moderate |
|
| Overall Satisfaction, Severe |
|
| Overall Satisfaction, Most Severe |
|
| Title | Measurements |
|---|---|
|
| Efficacy, 25% Worse (n=34) |
|
| Efficacy, Unchanged (n=34) |
|
| Efficacy, 25% Improve (n=34) |
|
| Efficacy, 50% Improve (n=34) |
|
| Efficacy, 75% Improve (n=34) |
|
| Efficacy, 100% Improve (n=34) |
|
| Safety, No (n=27) |
|
| Safety, Mild (n=27) |
|
| Safety, Moderate (n=27) |
|
| Safety, Severe (n=27) |
|
| Safety, Most severe (n=27) |
|
| Overall Satisfaction, No (n=27) |
|
| Overall Satisfaction, Mild (n=27) |
|
| Overall Satisfaction, Moderate (n=27) |
|
| Overall Satisfaction, Severe (n=27) |
|
| Overall Satisfaction, Most Severe (n=27) |
|