Low Back PainPhase 3NCT00346047
Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back Pain
A Phase 3 study testing Buprenorphine Transdermal System in people with Low Back Pain, run by Mundipharma K.K. at 29 sites in Japan.
Trial summary
The primary objective of this study is to evaluate the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe low back pain. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Buprenorphine Transdermal System
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 29 sitesJapan
- Study dates
- May 2006to Jul 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females age 20 years or older.
- Clinical diagnosis of low back pain for 4 weeks or longer with non-malignant pain etiology.
Who cannot join
- Subjects who have a current chronic disease(s) or who have a past history and high possibilities to relapse, in addition to low back pain, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, osteoarthritis and diabetic neuropathy).
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Japan29 sites
Investigational Site
Adachi City, Tokyo
Investigational Site
Arakawa City, Tokyo
Investigational Site
Asakura, Fukuoka
Investigational Site
Edogawa City, Tokyo
Investigational Site
Fukuoka, Fukuoka
Investigational Site
Hanamaki, Iwate
Investigational Site
Hikone, Shiga
Investigational Site
Ichikawa, Chiba
Investigational Site
Kanazawa, Ishikawa-ken
Investigational Site
Kobe, Hyōgo
Investigational Site
Komatsu, Ishikawa-ken
Investigational Site
Koshigaya, Saitama
Investigational Site
Matsudo, Chiba
Investigational Site
Morioka, Iwate
Investigational Site
Niigata, Niigata
Investigational Site
Noda, Chiba
Investigational Site
Osaka, Osaka
Investigational Site
Ōta-ku, Tokyo
Investigational Site
Sapporo, Hokkaido
Investigational Site
Sendai, Miyagi
Investigational Site
Suginami, Tokyo
Investigational Site
tabashi City, Tokyo
Investigational Site
Takasaki, Gunma
Investigational Site
Tokorozawa, Saitama
Investigational Site
Toshima City, Tokyo
Investigational Site
Wakasugi, Fukuoka
Investigational Site
Yao, Osaka
Investigational Site
Yokohama, Kanagawa
Investigational Site
Yūki, Ibaraki
About this study
Official title: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Determine the Efficacy and Safety of BTDS Compared to Placebo in Subjects With Moderate to Severe Low Back Pain
The primary objective of this study is to evaluate the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe low back pain.
Read the detailed description
The primary objective of this study is to evaluate the efficacy and safety of buprenorphine transdermal system (BTDS) compared to placebo in subjects with moderate to severe low back pain who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.
- Conditions
- Low Back Pain
- Being tested
- Placebo, Buprenorphine Transdermal System
- 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.
PlaceboDrug
Corresponding placebo is applied for 12weeks
Buprenorphine Transdermal SystemDrug
Buprenorphine Transdermal System 5, 10 or 20 mg/patch is applied for 12weeks
| Study group | Role | What they receive |
|---|---|---|
| 0 | Placebo comparator | Not described Receives: Drug: Placebo |
| 1 | Experimental | Not described Receives: Drug: Buprenorphine Transdermal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to the development of inadequate analgesia.
Measured: Up to 12weeks
Secondary outcomes (1)
Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mutsukuni Kataoka, Study chair, Department Head, Clinical Trial Operations, Clinical Development, Mundipharma K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346047
- Sponsor's protocol ID
- BUP3802
- Status last verified
- Apr 2008
- First submitted
- 27 Jun 2006
- Last updated
- 15 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Determine the Efficacy and Safety of BTDS Compared to Placebo in Subjects With Moderate to Severe Low Back Pain
- ClinicalTrials.gov ID
- NCT00346047
- Acronym / sponsor ID
- BUP3802
- Conditions
- Low Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Mundipharma K.K.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 29 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe low back pain.
Detailed description
The primary objective of this study is to evaluate the efficacy and safety of buprenorphine transdermal system (BTDS) compared to placebo in subjects with moderate to severe low back pain who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0 | Placebo comparator | Drug: Placebo |
| 1 | Experimental | Drug: Buprenorphine Transdermal System |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males or females age 20 years or older.
- Clinical diagnosis of low back pain for 4 weeks or longer with non-malignant pain etiology.
Key exclusion criteria (1 listed)
- Subjects who have a current chronic disease(s) or who have a past history and high possibilities to relapse, in addition to low back pain, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, osteoarthritis and diabetic neuropathy).
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 |
|---|---|---|
| PlaceboCorresponding placebo is applied for 12weeks | Drug | 0 |
| Buprenorphine Transdermal SystemBuprenorphine Transdermal System 5, 10 or 20 mg/patch is applied for 12weeks | Drug | 1 |
Primary outcome
The time to the development of inadequate analgesia.
Time frame: Up to 12weeks
1 secondary outcome
Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2008.
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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.
Mutsukuni Kataoka study chair
Department Head, Clinical Trial Operations, Clinical Development, Mundipharma K.K.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Buprenorphine Transdermal System in people with Low Back Pain, run by Mundipharma K.K. at 29 sites in Japan.
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 2 inclusion and 1 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 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Japan. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The time to the development of inadequate analgesia. (time frame: Up to 12weeks). 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 Apr 2008.