Low Back Pain
Conditions
Keywords
Low Back Pain, TTS-fentanyl, Durogesic
Brief summary
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 severe (very serious, life threatening) chronic (lasting a long time) low back pain in Thai participants.
Detailed description
This is an open label (all people know the identity of the intervention), single arm, prospective (study following participants forward in time) study conducted to assess the efficacy and safety of TTS-fentanyl in Thai participants with chronic low back pain. All participants start treatment with 12.5 micrograms (µg) per hour patch. The patches will be replaced every 3 days. On Day 3, and every 3 days thereafter, the TTS-fentanyl dose increases will be considered based on rescue medication consumption and pain assessment. No increase in TTS-fentanyl dose will be performed within the 72-hour dosing interval. The duration of the treatment will be 30 days. Primary efficacy assessment will be pain control rated by participants. Assessment time points will be at Day 0 (baseline), on 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.
Interventions
DRUGTTS-fentanyl
TTS-fentanyl patches releasing drug at the rate of 12.5 microgram (µg) per hour for 3 days. The patches will be replaced every 3 days until 30 days.
Sponsors
Janssen-Cilag Ltd.,Thailand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Chronic low back pain with moderate to severe pain at least 3 months -Participants needed to be treated with strong opioid and haven't been treated with strong opioid in the past -Participants who still had moderate to severe pain (Visual Analog Scale \[VAS\] \>= 4), which was not adequately controlled by weak opioids such as tramadol or codeine at optimal doses (at least 120 milligram \[mg\] per day for tramadol or 200 mg per day for codeine) for at least 7 consecutive days -Participants who failed from other treatments such as operation or lack of efficacy of current treatment -Participant who has signed the informed consent form
Exclusion criteria
-Skin disease that prevent the use of the transdermal system or which could affect the absorption of fentanyl or local tolerability -History or suspicion of alcohol or drug abuse within the past 5 years -History of cardiac, nervous system or respiratory disease which in the investigator's judgment precludes participation in the study because of the potential for respiratory depression -Concomitant use of Non Steroidal Anti-Inflammatory Drugs (NSAIDs), Cyclooxygenase - 2 (COX-2), muscle relaxant, topical analgesic during the previous week (unless on stable drug dose for at least 1 month before study entry) -Pregnancy or breast-feeding female; female participants of childbearing potential without adequate contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity at Day 15 | Day 15 | Pain control was assessed by using a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain. |
| Pain Intensity at Day 30 | Day 30 | Pain control was assessed by using a 10 cm VAS ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Investigator Global Assessment | Day 30 | Investigator completed 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 percent 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 Global Assessment | Day 30 | Participants completed a global assessment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent worse, 0=unchanged and 4=100 percent 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). |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days. | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Ineligible to continue the trial | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Transdermal Therapeutic System (TTS)-Fentanyl |
|---|---|
| Age Continuous | 55.80 years STANDARD_DEVIATION 11.53 |
| Pain Intensity Score by Visual Analog Scale (VAS) | 6.57 centimeter (cm) STANDARD_DEVIATION 1.44 |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 37 / 45 |
| serious Total, serious adverse events | 1 / 45 |
Outcome results
Primary
Pain Intensity at Day 15
Pain control was assessed by using a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.
Time frame: Day 15
Population: Intent-to-treat (ITT) population included all participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl | Pain Intensity at Day 15 | 4.85 cm | Standard Deviation 2.13 |
Primary
Pain Intensity at Day 30
Pain control was assessed by using a 10 cm VAS ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.
Time frame: Day 30
Population: ITT population included all participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl | Pain Intensity at Day 30 | 4.89 cm | Standard Deviation 2.46 |
Secondary
Number of Participants With Investigator Global Assessment
Investigator completed 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 percent 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).
Time frame: Day 30
Population: Per protocol (PP) population included all participants who completed the 30-day study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Efficacy, 100 percent worse | 0 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Efficacy, 75 percent worse | 1 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Efficacy, 50 percent worse | 2 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Efficacy, 25 percent worse | 1 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Efficacy, unchanged | 6 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Efficacy, 25 percent improvement | 6 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Efficacy, 50 percent improvement | 11 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Efficacy, 75 percent improvement | 6 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Efficacy, 100 percent improvement | 1 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Safety, no | 17 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Safety, mild | 15 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Safety, moderate | 1 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Safety, severe | 1 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Safety, most severe | 0 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Overall satisfaction, no | 6 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Overall satisfaction, mild | 8 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Overall satisfaction, moderate | 11 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Overall satisfaction, good | 7 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Investigator Global Assessment | Overall satisfaction, excellent | 2 participants |
Secondary
Number of Participants With Participant Global Assessment
Participants completed a global assessment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent worse, 0=unchanged and 4=100 percent 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).
Time frame: Day 30
Population: PP population included all participants who completed the 30-day study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Efficacy, 100 percent improvement | 1 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Efficacy, 100 percent worse | 1 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Efficacy, 75 percent worse | 0 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Efficacy, 50 percent worse | 2 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Efficacy, 25 percent worse | 1 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Efficacy, unchanged | 4 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Efficacy, 25 percent improvement | 13 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Efficacy, 50 percent improvement | 11 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Efficacy, 75 percent improvement | 1 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Safety, no | 12 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Safety, mild | 15 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Safety, moderate | 6 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Safety, severe | 0 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Safety, most severe | 1 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Overall satisfaction, no | 3 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Overall satisfaction, mild | 10 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Overall satisfaction, moderate | 15 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Overall satisfaction, good | 5 participants |
| Transdermal Therapeutic System (TTS)-Fentanyl | Number of Participants With Participant Global Assessment | Overall satisfaction, excellent | 1 participants |