Efficacy Study to Evaluate EN3409 in Opioid-naive Subjects

This study has been completed.
BioDelivery Sciences International
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
First received: July 2, 2012
Last updated: April 14, 2014
Last verified: March 2014

The purpose of this study is to determine if EN3409 is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock pain relief for an extended period of time.

Condition Intervention Phase
Low Back Pain
Drug: EN3409
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3, Double-Blind, Placebo-Controlled, Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of EN3409 in Opioid-Naive Subjects With Chronic Low Back Pain Requiring Opioid Analgesia

Resource links provided by NLM:

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Determine the analgesic efficacy of EN3409 in opioid-naive subjects with moderate to severe CLBP requiring continuous ATC opioid analgesia [ Time Frame: Change from baseline to Week 12 of double-blind treatment phase in the mean of average daily pain intensity scores ] [ Designated as safety issue: No ]

Enrollment: 462
Study Start Date: August 2012
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Twice Daily Dosing
Experimental: EN3409 Drug: EN3409
Twice Daily Dosing


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of moderate to severe low back pain for >/- 6 months
  • Treating chronic low back pain (CLPB) with a stable daily maintenance dose of non-opioid pain medication
  • Stable health, as determine by Principal Investigator
  • Are female who are participating abstinece or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year
  • Willing and able to comply with all protocol required visits and assessments

Exclusion Criteria:

  • Current cancer related pain or received chemotherapy with 6 months of screening
  • Subjects with a history of other chronic painful conditions
  • Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, caudia equina compression, acute nerve root compression, meningitis, or discitis
  • Allergy or contraindications to any opioid or acetaminophen
  • Surgical procedure for relief of pain with 6 months
  • Moderate to severe hepatic impairment
  • Moderate to severe renal impairment
  • Current or past history of alcohol abuse
  • Positive urine toxicology screen for drug of abuse
  • History or abnormalities on physical exam, vital signs, ECG, or lab values
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01633944

  Show 60 Study Locations
Sponsors and Collaborators
Endo Pharmaceuticals
BioDelivery Sciences International
Study Director: Andrew Finn, PharmD BioDelivery Sciences International, Inc.
  More Information

No publications provided

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01633944     History of Changes
Other Study ID Numbers: EN3409-308
Study First Received: July 2, 2012
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
Low Back Pain
Back Pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2015