Low Back PainPhase 3NCT00228605
Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain
A Phase 3 study testing OraVescent Fentanyl in people with Low Back Pain and Migraine, run by Cephalon at 38 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl for the potential treatment of breakthrough pain episodes in patients who have chronic noncancer pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain, Migraine, Diabetic Neuropathies
- What is being tested?
- OraVescent Fentanyl
- How many people
- 500 participants
- Where
- 38 sitesUnited States
- Study dates
- Mar 2005to May 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pain diagnosis
- Opioid tolerant
- Has on average 1-4 breakthrough pain episodes per day
Who cannot join
- Drug abuse history
- Cardiopulmonary disease
- Monoamine oxidase inhibitors (MAOIs)
- Expected to have surgery to relieve the pain
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Center for Prospective Outcome Studies, Inc.
Atlanta, Georgia, 30327
Advent Clinical Research Centers, Inc.
Atlanta, Georgia, 30342
Northwest Clinical Research Center
Bellevue, Washington, 98004
Northshore University Hospital
Bethpage, New York, 11714
Orthopedic Health Care
Boise, Idaho, 83702
Brigham Women's Hospital, Attn: Pain Trials Center
Boston, Massachusetts, 02115
MedSearch
Calera, Alabama, 35040
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80909
Radiant Research-Daytona Beach
Daytona Beach, Florida, 32114
Iowa Pain Management Clinic, PC
Des Moines, Iowa, 50265
Medisphere Medical Research Center, LLC
Evansville, Indiana, 47714
Tri-State Arthritis & Rheumatology Center, LLC
Evansville, Indiana, 47714
Clinical Research Consultants, Inc.
Hoover, Alabama, 35216
NEA Clinic
Jonesboro, Arkansas, 72404
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104
Center for Prospective Outcome Studies, Inc.
Marietta, Georgia, 30060
Southern Oregon Health & Wellness
Medford, Oregon, 97504
Healthstar Physicians
Morristown, Tennessee, 37813
NYU Pain Management Center
New York, New York, 10016
Research Across America
New York, New York, 10022
The Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Mid-America Physiatrists, PA
Overland Park, Kansas, 66211
Arizona Research Center
Phoenix, Arizona, 85023
Capital Clinical Research Associates, LLC
Rockville, Maryland, 20852
North Fulton Regional Hospital Pain Center
Roswell, Georgia, 30076
Lifetree Clinical Research
Salt Lake City, Utah, 84106
Radiant Research
Salt Lake City, Utah, 84107
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Carmen Research
Smyrna, Georgia, 30080
Pain Management Center
South Burlington, Vermont, 05403
Rowan Research
Spokane, Washington, 99207
Medex Healthcare Research Center
St Louis, Missouri, 63108
Radiant Research - St. Louis
St Louis, Missouri, 63141
Advent Clinical Research Centers, Inc.
St. Petersburg, Florida, 33703
Biopharma Research Associates
Sugar Land, Texas, 77479
MedVadis Research
Wellesley Hills, Massachusetts, 02481-2106
Clinical Research Center of Reading, LLP
West Reading, Pennsylvania, 19611
Gold Coast Research
Weston, Florida, 33331
About this study
Official title: An Open-Label 12 Month Study to Evaluate the Safety, Tolerability and Efficacy of OraVescent Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Noncancer Pain
The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl for the potential treatment of breakthrough pain episodes in patients who have chronic noncancer pain.
- Conditions
- Low Back Pain, Migraine, Diabetic Neuropathies, Osteoarthritis
- Being tested
- OraVescent Fentanyl
- Keywords
- Pain, Sudden Pain, Flares, noncancer, low back pain, neuropathic pain, osteoarthritis pain, migraine, chronic headache, diabetic peripheral neuropathy
- Medical subject headings
- Low Back Pain, Migraine Disorders, Diabetic Neuropathies, Osteoarthritis, Pain, Neuralgia, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraVescent FentanylDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients
Secondary outcomes (3)
Assess the patients' quality of life through questionnaires
Assess the patients' overall medication preferences
Assess the patients' overall medication performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startMar 2005
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gwendolyn Neibler, DO, Study director, Cephalon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228605
- Sponsor's protocol ID
- C25608/3040/BP/US
- Status last verified
- May 2014
- First submitted
- 27 Sep 2005
- Last updated
- 9 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label 12 Month Study to Evaluate the Safety, Tolerability and Efficacy of OraVescent Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Noncancer Pain
- ClinicalTrials.gov ID
- NCT00228605
- Acronym / sponsor ID
- C25608/3040/BP/US
- Conditions
- Low Back Pain, Migraine, Diabetic Neuropathies, Osteoarthritis
- Keywords
- Pain, Sudden Pain, Flares, noncancer, low back pain, neuropathic pain, osteoarthritis pain, migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- May 2007 (actual)
- First posted
- 29 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl for the potential treatment of breakthrough pain episodes in patients who have chronic noncancer pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic pain diagnosis
- Opioid tolerant
- Has on average 1-4 breakthrough pain episodes per day
Key exclusion criteria (4 listed)
- Drug abuse history
- Cardiopulmonary disease
- Monoamine oxidase inhibitors (MAOIs)
- Expected to have surgery to relieve the pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OraVescent Fentanyl | Drug | – |
Primary outcome
Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients
3 secondary outcomes
Assess the patients' quality of life through questionnaires
Assess the patients' overall medication preferences
Assess the patients' overall medication performance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwendolyn Neibler, DO study director
Cephalon
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OraVescent Fentanyl in people with Low Back Pain and Migraine, run by Cephalon at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2014.