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OpenTrials
Completed

NCT Number: NCT00485225

Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-malignant, Chronic Pain

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.

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Key information

Conditions

Chronic, Non Malignant Pain Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EN3270

Drug

Transdermal Therapeutic System

Primary outcomes

  1. Safety and minimum titration period

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Durect

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 12, 2007
Registry last updated
Feb 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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