Chronic, Non Malignant Pain Clinical Trial
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.
| Verified date | December 2011 |
| Source | Durect |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 77 |
| Est. completion date | July 2008 |
| Est. primary completion date | April 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Comprehensive Clinical Research | Berlin | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Durect |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety and minimum titration period | 12 weeks | Yes |