Low Back PainPhase 4NCT01774903
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Severe Chronic Low Back Pain
A Phase 4 study testing TTS-fentanyl in people with Low Back Pain, run by Janssen-Cilag Ltd.,Thailand at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- TTS-fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2008to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Study of Efficacy and Safety of TTS-Fentanyl in Severe Chronic Low Back Pain
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- TTS-fentanyl
- Keywords
- Low Back Pain, TTS-fentanyl, Durogesic
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTS-fentanylDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| TTS-fentanyl | Experimental | Not described Receives: Drug: TTS-fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 15
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.
Measured: Day 30
Secondary outcomes (2)
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).
Measured: Day 30
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).
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 posted24 Jan 2013 (estimated)
- Study startAug 2008
- Primary completionJun 2009
- Study completionJun 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 Low Back PainStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.,Thailand
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd.,Thailand Clinical trial, Study director, Janssen-Cilag Ltd.,Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774903
- Sponsor's protocol ID
- CR014533
- Other IDs
- FENPAI4051
- Status last verified
- Feb 2013
- First submitted
- 21 Jan 2013
- Last updated
- 25 Mar 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 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Study of Efficacy and Safety of TTS-Fentanyl in Severe Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01774903
- Acronym / sponsor ID
- CR014533
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, TTS-fentanyl, Durogesic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.,ThailandIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Posted 25 Mar 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TTS-fentanyl | Experimental | Drug: TTS-fentanyl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| TTS-fentanylTTS-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. | Drug | TTS-fentanyl |
Primary outcome
Pain Intensity at Day 15
Time frame: 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
Time frame: 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.
2 secondary outcomes
Number of Participants With Investigator Global Assessment
Time frame: Day 30
Number of Participants With Participant Global Assessment
Time frame: Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 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-Cilag Ltd.,Thailand Clinical trial study director
Janssen-Cilag Ltd.,Thailand
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 TTS-fentanyl in people with Low Back Pain, run by Janssen-Cilag Ltd.,Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Mar 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 Thailand. 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 25 Mar 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?
Pain Intensity at Day 15 (time frame: Day 15). The study lists 2 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 25 Mar 2013.