Completed
Phase 3, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia
What is being tested
Placebo
+ Buprenorphine
Drug
Who is being recruted
Neurologic Manifestations+4
+ Pain
+ Signs and Symptoms
Over 18 Years
+18 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 3
Interventional
Study Start: September 2012
Summary
Principal SponsorBioDelivery Sciences International
Last updated: February 27, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.The purpose of the study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-experienced subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.
Principal SponsorBioDelivery Sciences International
Last updated: February 27, 2017
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
815 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Neurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsBack PainLow Back PainChronic Pain
Criteria
5 inclusion criteria required to participate
Diagnosis of moderate to severe low back pain for >= 6 months
Females are practicing abstinence, using a medically acceptable form of contraception, or post-menopausal, biologically sterile, or surgically sterile for more than 1 year
Stable health, as determine by Principal Investigator
Treating CLBP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to >= 30 mg and <= 160 mg morphine sulfate equivalents (MSE) per day for >= 4 weeks. (Additional as needed [PRN] analgesic rescue medications permitted on top of the stable daily maintenance dose of >= 30 mg MSE opioid analgesic, but must be included in the total daily MSE calculation and in combination with the stable daily maintenance dose not to exceed 160 mg MSE per day)
Show More Criteria
13 exclusion criteria prevent from participating
Allergy or contraindications of any opioid or acetaminophen
Current cancer related pain or received chemotherapy within 6 months of screening
Current or past history of alcohol abuse
History of long QT syndrome or a family member with this condition
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboTwice Daily Dosing
Group II
ExperimentalTwice Daily Dosing
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 66 locations
Haleyville Clinical Research LLC
Haleyville, United StatesHorizon Research Group. Inc / Alabama Orthopedice
Mobile, United StatesArizona Research Center
Phoenix, United StatesCompleted66 Study Centers