Long-term Open-Label Safety Study to Evaluate EN3409 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Low Back Pain Osteoarthritis Neuropathic Pain	Drug: EN3409	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 3, Open-label, Long-term Study to Evaluate the Safety, Tolerability, and Analgesic Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain Requiring Continuous Around-the-Clock Opioid Analgesia for an Extended Period of Time

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Chronic Pain Osteoarthritis

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:

To determine the long-term safety and tolerability of BEMA Buprenorphine (dosed every 12 hours [Q12h]) in subjects with moderate to severe chronic pain (CP) requiring continuous around-the-clock (ATC) opioid analgesia for an extended period of time [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]


Enrollment:	554
Study Start Date:	December 2012
Study Completion Date:	November 2014
Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: EN3409 Buprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily	Drug: EN3409 Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily Other Name: Buprenorphine HCI Buccal Film 300-900 mcg twice daily

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female subjects who are practicing abstinence or using a medically acceptable form of contraception or have been postmenopausal, biologically sterile, or surgically sterile for more than 1 year
Male subjects who are practicing abstinence, surgically sterile, or are using a medically acceptable form of contraception
De Novo subject with a clinical diagnosis of moderate to severe noncancer-related CP (eg, CLBP, OA, neuropathic pain) for ≥ 3 months
De Novo subject that is treating their CP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥ 60 mg and ≤ 160 mg Morphine Sulfate Equivalent (MSE) per day for ≥ 4 weeks
Stable health, as determined by the Principal Investigator
Subject is willing and able to comply with all protocol required visits and assessments
Rollover subject who has completed the 12-week Double-blind Treatment Phase in the EN3409-307/308 clinical study

Exclusion Criteria:

A history or current evidence of any clinically significant disorder or any other condition, which in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
Females who are pregnant, breastfeeding, or plan to become pregnant during the study
Current cancer-related pain or received chemotherapy within 6 months of screening
Subjects receiving opioid analgesic medication < 60 mg MSE per day within 28 days of screening
De novo subjects receiving opioid analgesic medication at doses of > 160 mg MSE per day within 28 days of screening
Subjects with a history of other chronic painful conditions, other than the index CP condition, which require frequent analgesic medication
Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
History of allergy or contraindications to any opioid or acetaminophen
Surgical procedure for relief of pain within 6 months, or nerve/plexus block within 28 days of screening
Hypokalemia or clinically unstable cardiac disease
Moderate to severe hepatic impairment
Moderate to severe renal impairment
Current or past history of alcohol or substance
Positive urine toxicology screen for drugs of abuse
History of 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: NCT01755546

Show 57 Study Locations

Sponsors and Collaborators

Endo Pharmaceuticals

BioDelivery Sciences International

Investigators


Study Director:	Andrew Finn, PharmD	BioDelivary Sciences Internantional, Inc.

More Information


Responsible Party:	Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01755546 History of Changes
Other Study ID Numbers:	EN3409-309
Study First Received:	December 19, 2012
Last Updated:	June 10, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:


Chronic Pain CLBP Chronic Low Back Pain Back Pain Osteoarthritis	OA Neuropathic Pain Nerve pain Painful neuropathy

Additional relevant MeSH terms:


Osteoarthritis Back Pain Low Back Pain Neuralgia Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms	Peripheral Nervous System Diseases Neuromuscular Diseases Buprenorphine Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists

ClinicalTrials.gov processed this record on September 29, 2016