Long-term Open-Label Safety Study to Evaluate EN3409
This study has been completed.
Sponsor:
Endo Pharmaceuticals
Collaborator:
BioDelivery Sciences International
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01755546
First received: December 19, 2012
Last updated: November 14, 2014
Last verified: November 2014
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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:
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 | Drug: EN3409 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| 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
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
No publications provided
| 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: | November 14, 2014 |
| 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 |
ClinicalTrials.gov processed this record on March 03, 2015