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: June 10, 2015
Last verified: June 2015
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: Buprenorphine
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:
  • Mean change in average daily pain [ Time Frame: Baseline to Week 12 of double-blind treatment phase in the mean of average daily pain intensity scores ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cumulative proportion of subjects who achieved percent pain reductions [ Time Frame: Prior to open label titration to week 12 in double blind treatment phase ] [ Designated as safety issue: No ]
  • Number of subjects with non-opioid and opioid rescue medication use by week [ Time Frame: 12 week double-blind treatment phase ] [ Designated as safety issue: No ]
  • Time to treatment failure in double blind treatment pahse [ Time Frame: 12 week double-blind treatment phase ] [ Designated as safety issue: No ]
  • Time to optimal dose open label study medication [ Time Frame: number of days from the date of the first dose of the study medication to the date of the first dose of the subjects optimal dose of study medication ] [ Designated as safety issue: No ]
  • Patient reported outcome measures [ Time Frame: Change from Baseline to week 12 double blind ] [ 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
Twice Daily Dosing
Drug: Placebo
Matching Placebo Buccal Film twice daily
Other Names:
  • Placebo Buccal Film
  • BEMA Placebo
Experimental: Buprenorphine HCl Buccal Film
Twice Daily Dosing
Drug: Buprenorphine
Buprenorphine HCl Buccal Film at doses ranging from 75-600 mcg twice daily
Other Names:
  • Buprenorphine HCl Buccal Film
  • BEMA Buprenorphine


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: M. Todd Kirby, PhD Endo Pharmaceuticals
  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: June 10, 2015
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
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2015