Low Back Pain, Osteoarthritis
Conditions
Keywords
Osteoarthritis, Low back pain, Fentanyl transdermal patch, Durogesic-D-Trans
Brief summary
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.
Detailed description
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.
Interventions
DRUGFentanyl
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).
Sponsors
Janssen Pharmaceutica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants diagnosed with osteoarthritis and chronic low back pain * 3 months of persistent moderate to severe pain levels * More than 3 times a week frequency or daily moderate to severe pain * Moderate to severe pain at Baseline (at least a score of 4 in the 11-point numerical pain scale)
Exclusion criteria
* History of allergy to fentanyl transdermal patch or its components and history of illicit drug use for the past 3 months * Active skin disease preventing application of the transdermal system * Chronic pulmonary disease (lung disorder) * Participants susceptible to intracranial (inside the skull) effects of carbon dioxide retention * Pregnant and breastfeeding mothers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 | Baseline and 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. |
| Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | Baseline and 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. |
| Number of Participants Requiring Rescue Medication | Day 30 | 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. |
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician | Day 30 | 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. |
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant | Day 30 | 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. |
Countries
Philippines
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 237 |
| Total | 237 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 27 |
| Overall Study | Death | 1 |
| Overall Study | Diagnosed with metastasis | 1 |
| Overall Study | Lost to Follow-up | 20 |
| Overall Study | No pain | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal of consent | 6 |
| Overall Study | Withdrew consent & had adverse events | 3 |
Baseline characteristics
| Characteristic | Fentanyl |
|---|---|
| Age Continuous | 48.202 Years STANDARD_DEVIATION 11.137 |
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician Minimally improved | 38 Participants |
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician Much improved | 93 Participants |
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician No change | 21 Participants |
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician Not evaluated | 46 Participants |
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician Very Much improved | 5 Participants |
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant Minimally improved | 40 Participant |
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant Much improved | 88 Participant |
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant No change | 21 Participant |
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant Not evaluated | 46 Participant |
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant Very Much improved | 8 Participant |
| Sex: Female, Male Female | 174 Participants |
| Sex: Female, Male Male | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 156 / 237 |
| serious Total, serious adverse events | 5 / 237 |
Outcome results
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.
Time frame: Baseline and Day 30
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | Baseline: General activity | 5.73 Units on a scale | Standard Deviation 2.02 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | Baseline: Mood | 4.94 Units on a scale | Standard Deviation 2.288 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | Baseline: Walking ability | 5.25 Units on a scale | Standard Deviation 2.417 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | Baseline: Normal work | 5.34 Units on a scale | Standard Deviation 2.242 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | Baseline: Relationship w/others | 4.33 Units on a scale | Standard Deviation 2.345 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | Baseline: Sleep | 5.05 Units on a scale | Standard Deviation 2.43 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | Baseline: Enjoyment of life | 4.71 Units on a scale | Standard Deviation 2.513 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | Change at Day 30: General activity | -4.502 Units on a scale | Standard Deviation 2.47 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | Change at Day 30: Mood | -4.118 Units on a scale | Standard Deviation 2.487 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | Change at Day 30: Walking ability | -4.182 Units on a scale | Standard Deviation 2.618 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | Change at Day 30: Normal work | -4.251 Units on a scale | Standard Deviation 2.504 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | Change at Day 30: Relationship w/others | -3.700 Units on a scale | Standard Deviation 2.486 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | Change at Day 30: Sleep | -4.355 Units on a scale | Standard Deviation 2.639 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 | Change at Day 30: Enjoyment of life | -3.966 Units on a scale | Standard Deviation 2.611 |
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.
Time frame: Baseline and Day 30
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 | Baseline: Worst | 7.20 Units on a scale | Standard Deviation 1.922 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 | Baseline: Least | 3.83 Units on a scale | Standard Deviation 1.904 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 | Baseline: Average | 5.59 Units on a scale | Standard Deviation 1.682 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 | Baseline: Right now | 5.49 Units on a scale | Standard Deviation 2.121 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 | Change at Day 30: Worst | -5.000 Units on a scale | Standard Deviation 2.661 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 | Change at Day 30: Least | -3.049 Units on a scale | Standard Deviation 2.124 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 | Change at Day 30: Average | -4.246 Units on a scale | Standard Deviation 2.096 |
| Fentanyl | Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 | Change at Day 30: Right now | -4.404 Units on a scale | Standard Deviation 2.464 |
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.
Time frame: Day 30
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl | Number of Participants Requiring Rescue Medication | 41 Participants |
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.
Time frame: Day 30
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fentanyl | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician | Very much worse | 1 Participants |
| Fentanyl | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician | No change | 5 Participants |
| Fentanyl | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician | Minimally improved | 16 Participants |
| Fentanyl | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician | Much improved | 30 Participants |
| Fentanyl | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician | Very Much improved | 151 Participants |
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.
Time frame: Day 30
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fentanyl | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant | Very much worse | 1 Participants |
| Fentanyl | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant | Minimally worse | 1 Participants |
| Fentanyl | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant | No change | 5 Participants |
| Fentanyl | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant | Minimally improved | 14 Participants |
| Fentanyl | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant | Much improved | 33 Participants |
| Fentanyl | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant | Very Much improved | 149 Participants |