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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00485225
Other study ID # EN3270-201
Secondary ID
Status Completed
Phase Phase 2
First received June 8, 2007
Last updated February 21, 2012
Start date June 2007
Est. completion date July 2008

Study information

Verified date December 2011
Source Durect
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
EN3270
Transdermal Therapeutic System

Locations

Country Name City State
United States Comprehensive Clinical Research Berlin New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Durect

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and minimum titration period 12 weeks Yes