Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-malignant, Chronic Pain
CompletedPhase 2NCT00485225
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- 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.
- Conditions
- Chronic, Non Malignant Pain
- Interventions
- Drug: EN3270
- Sponsor
- Durect
- Start date
- 2007-06
- Primary completion
- 2008-04
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00485225