OsteoarthritisPhase 4NCT01795898
An Efficacy and Safety Study of Fentanyl Transdermal Patch in Filipino Participants With Osteoarthritis and Chronic Low Back Pain
A Phase 4 study testing Fentanyl in people with Osteoarthritis and Low Back Pain, run by Janssen Pharmaceutica at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoarthritis, Low Back Pain
- What is being tested?
- Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 sitePhilippines
- Study dates
- Jan 2009to Sep 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Chronic pulmonary disease (lung disorder)
- Participants susceptible to intracranial (inside the skull) effects of carbon dioxide retention
- Pregnant and breastfeeding mothers
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy, Safety and Quality of Life Outcome of Fentanyl Transdermal Patch (Durogesic-D-Trans) Among Filipino Patients With Osteoarthritis and Chronic Low Back Pain
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.
Read the 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.
- Conditions
- Osteoarthritis, Low Back Pain
- Being tested
- Fentanyl
- Keywords
- Osteoarthritis, Low back pain, Fentanyl transdermal patch, Durogesic-D-Trans
- Medical subject headings
- Osteoarthritis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called DUROGESIC-D-TRANS
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutica Clinical trial, Study director, Janssen Pharmaceutica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795898
- Sponsor's protocol ID
- CR015268
- Other IDs
- FENPAI4074
- Status last verified
- Jun 2013
- First submitted
- 19 Feb 2013
- Last updated
- 15 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Quality of Life Outcome of Fentanyl Transdermal Patch (Durogesic-D-Trans) Among Filipino Patients With Osteoarthritis and Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01795898
- Acronym / sponsor ID
- CR015268
- Conditions
- Osteoarthritis, Low Back Pain
- Keywords
- Osteoarthritis, Low back pain, Fentanyl transdermal patch, Durogesic-D-Trans
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Janssen PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Posted 15 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fentanyl transdermal patch | Experimental | Drug: FentanylFentanyl 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylAlso: DUROGESIC-D-TRANSFentanyl 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). | Drug | Fentanyl transdermal patch |
Primary outcome
Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutica Clinical trial study director
Janssen Pharmaceutica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl in people with Osteoarthritis and Low Back Pain, run by Janssen Pharmaceutica at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 (time frame: Baseline and Day 30). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2013.