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Long-term Open-Label Safety Study to Evaluate EN3409

NCT01755546 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2018-10-18

Study results available
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Summary

The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.

Conditions

Interventions

DRUG

EN3409

Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily

Sponsors & Collaborators

  • BioDelivery Sciences International

    lead INDUSTRY

Principal Investigators

  • Andrew Finn, PharmD · BioDelivary Sciences Internantional, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-10-31
Completion
2014-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01755546 on ClinicalTrials.gov