Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-malignant, Chronic Pain
Completed · Phase 2
Conditions studied: Chronic, Non Malignant Pain
In brief
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.
Key facts
- Study ID
- NCT00485225
- Run by
- Durect
- People needed
- 77
- Starts
- 2007-06-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2012-02-23
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- 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
Where it is running
- Comprehensive Clinical Research — Berlin, New Jersey, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.