Chronic, Non Malignant PainPhase 2NCT00485225
Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-malignant, Chronic Pain
A Phase 2 study testing EN3270 in people with Chronic, Non Malignant Pain, run by Durect at 1 site in United States.
Trial summary
Two stage study looking at different titration schedules in patients with moderate to severe non-malignant chronic pain. Up to 80 patients at approximately 15 centers in the US to be enrolled. Study participation is approximately 3 months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic, Non Malignant Pain
- What is being tested?
- EN3270
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jul 2008
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Opioid experienced
- Hx (min 3 months) of moderate to severe pain of non-malignant that is well controlled with current pain therapy
- On a stable dose of opioid medication for greater than or equal to 14 days
- Have an adequate personal support system including a co-habitant
- Are able and willing to follow verbal and written instructions and provide written informed consent
Who cannot join
- Are pregnant or lactating
- Have pain secondary to a confirmed or suspected neoplasm
- Have a history or physical examination finding incompatible with safe participation in the study
- Have a history of alcohol or drug abuse
- Have a history or physical examination finding of clinically significant skin abnormalities that would preclude use of a transdermal patch (e.g., psoriasis)
- Have a history of or currently manifesting a clinically significant psychiatric disorder
Show all 10Show fewer
- Have a known history of allergy that negatively impacts respiratory function to a clinically significant level
- Plan to have an MRI while on the study
- Have any clinically significant condition that would, in the opinion of the investigator, preclude safe study participation
- Are scheduled for surgery requiring general anesthesia within the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Clinical Research
Berlin, New Jersey, 08009
About this study
Official title: An Open-Label, Two-Stage, Phase II Study to Explore the Titration Schedule for Transitioning Opioid-Experienced Patients With Non-Malignant Moderate to Severe Chronic Pain From Current Opioid Therapy to EN3270.
Two stage study looking at different titration schedules in patients with moderate to severe non-malignant chronic pain. Up to 80 patients at approximately 15 centers in the US to be enrolled. Study participation is approximately 3 months.
- Conditions
- Chronic, Non Malignant Pain
- Being tested
- EN3270
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EN3270Drug
Transdermal Therapeutic System
| Study group | Role | What they receive |
|---|---|---|
| Transdermal patch (EN3270) - Titration 1 | Experimental | Not described Receives: Drug: EN3270 |
| Transdermal patch (EN3270) - Titration 2 | Experimental | Not described Receives: Drug: EN3270 |
| Transdermal patch (EN3270) - Titration 3 | Experimental | Not described Receives: Drug: EN3270 |
| Transdermal patch (EN3270) - Titration 4 | Experimental | Not described Receives: Drug: EN3270 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and minimum titration period
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionApr 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic, Non Malignant 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durect
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485225
- Sponsor's protocol ID
- EN3270-201
- Status last verified
- Dec 2011
- First submitted
- 8 Jun 2007
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Two-Stage, Phase II Study to Explore the Titration Schedule for Transitioning Opioid-Experienced Patients With Non-Malignant Moderate to Severe Chronic Pain From Current Opioid Therapy to EN3270.
- ClinicalTrials.gov ID
- NCT00485225
- Acronym / sponsor ID
- EN3270-201
- Conditions
- Chronic, Non Malignant Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- DurectIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 12 Jun 2007 (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.
Two stage study looking at different titration schedules in patients with moderate to severe non-malignant chronic pain. Up to 80 patients at approximately 15 centers in the US to be enrolled. Study participation is approximately 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transdermal patch (EN3270) - Titration 1 | Experimental | Drug: EN3270 |
| Transdermal patch (EN3270) - Titration 2 | Experimental | Drug: EN3270 |
| Transdermal patch (EN3270) - Titration 3 | Experimental | Drug: EN3270 |
| Transdermal patch (EN3270) - Titration 4 | Experimental | Drug: EN3270 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Opioid experienced
- Hx (min 3 months) of moderate to severe pain of non-malignant that is well controlled with current pain therapy
- On a stable dose of opioid medication for greater than or equal to 14 days
- Have an adequate personal support system including a co-habitant
- Are able and willing to follow verbal and written instructions and provide written informed consent
Key exclusion criteria (10 listed)
- Are pregnant or lactating
- Have pain secondary to a confirmed or suspected neoplasm
- Have a history or physical examination finding incompatible with safe participation in the study
- Have a history of alcohol or drug abuse
- Have a history or physical examination finding of clinically significant skin abnormalities that would preclude use of a transdermal patch (e.g., psoriasis)
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 |
|---|---|---|
| EN3270Transdermal Therapeutic System | Drug | Transdermal patch (EN3270) - Titration 1, Transdermal patch (EN3270) - Titration 2, Transdermal patch (EN3270) - Titration 3, Transdermal patch (EN3270) - Titration 4 |
Primary outcome
Safety and minimum titration period
Time frame: 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 23 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EN3270 in people with Chronic, Non Malignant Pain, run by Durect at 1 site in United States.
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 5 inclusion and 10 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 23 Feb 2012. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety and minimum titration period (time frame: 12 weeks). 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 23 Feb 2012.