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Efficacy Study to Evaluate EN3409 in Opioid-naive Subjects

This study is currently recruiting participants.
Verified October 2012 by Endo Pharmaceuticals
Sponsor:
Collaborator:
BioDelivery Sciences International
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01633944
First received: July 2, 2012
Last updated: January 11, 2013
Last verified: October 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

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 ]

Estimated Enrollment: 444
Study Start Date: August 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633944

Contacts
Contact: BEMA EN3409-308 800-982-3379

  Show 59 Study Locations
Sponsors and Collaborators
Endo Pharmaceuticals
BioDelivery Sciences International
Investigators
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: January 11, 2013
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
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 19, 2013