PainPhase 3NCT00105937
OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
A Phase 3 study testing OraVescent fentanyl citrate in people with Pain and Cancer, run by Cephalon at 43 sites in United States.
Trial summary
The purpose of this study is to evaluate the long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- OraVescent fentanyl citrate
- How many people
- 300 participants
- Where
- 43 sitesUnited States
- Study dates
- Apr 2004to Nov 2006
- 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
- 18-80 years of age
- Average of 1-4 breakthrough pain episodes per day
- Opioid tolerant
- Histologically documented diagnosis of a malignant solid tumor or hematological malignancy
Who cannot join
- Primary breakthrough pain is not related to cancer in any way
- Opioid or fentanyl intolerance
- Chronic obstructive pulmonary disease (COPD) or heart disease
- Sleep apnea or active brain metastases with increased cranial pressure
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Cancer Outreach Associates, PC
Abingdon, Virginia, 24211
Allegheny Pain Management, PC
Altoona, Pennsylvania, 16601
Southeastern Gynecologic Oncology, LLC
Atlanta, Georgia, 30342
St. Agnes Healthcare
Baltimore, Maryland, 21229
City of Hope National Medical Center
Duarte, California, 91010
Oncology Associates of Oregon
Eugene, Oregon, 97401
Kentucky Cancer Clinic
Hazard, Kentucky, 41701
Hot Spring Pain Clinic
Hot Springs, Arkansas, 71913
Saint Joseph's Mercy Cancer Center
Hot Springs, Arkansas, 71913
Center for Pain Management
Huntsville, Alabama, 35801
Florida Institute of Medical Research
Jacksonville, Florida, 32207
University of Florida Shands Cancer Center at Jacksonville
Jacksonville, Florida, 32209
Southwest Oncology Associates
Lafayette, Louisiana, 70503
Hematology Oncology Associates
Lake Worth, Florida, 33461-4710
St. Mary Medical Center
Langhorne, Pennsylvania, 19047
University of Wisconsin Medical School
Madison, Wisconsin, 53792-5669
North Shore University Hospital
Manhasset, New York, 11030
Innovative Medical Research of South Florida
Miami Shores, Florida, 33138
Hematology and Oncology Specialists
New Orleans, Louisiana, 70115
Beth Israel Medical Center
New York, New York, 10003
Mohamed Haq
Pasadena, Texas, 77504
Arkansas Cancer Institute
Pine Bluff, Arkansas, 71603
Huron Medical Center
Port Huron, Michigan, 48067
MedSource Inc
Richmond, Virginia, 23229
Bond Clinic, Inc
Rolla, Missouri, 65407
Hunstman Cancer Institute
Salt Lake City, Utah, 84112
Palliative Care and Pain Medicine
Salt Lake City, Utah, 84157
Cancer Care Centers of South Texas
San Antonio, Texas, 78229
North Shore Cancer Research Association
Skokie, Illinois, 60076
The Cancer Prevention and Treatment Center
Soquel, California, 95073
Providence Cancer Institute
Southfield, Michigan, 48075
HealthCare Research, LLC
St Louis, Missouri, 63141
Gulf Coast Oncology Association
St. Petersburg, Florida, 33705
Clinical Pharmacology Services, Inc
Tampa, Florida, 33617
Northwestern Connecticut Oncology & Hematology Associates
Torrington, Connecticut, 06790
Outcomes Research International
Tucson, Arizona, 85711
Arizona Clinical Research Center
Tucson, Arizona, 85712
PETC Research Group, Inc.
Tulsa, Oklahoma, 74137
UTHCT (ATTN: Clinical Research)
Tyler, Texas, 75708
Palm Beach Research
West Palm Beach, Florida, 33409
Great Basin Clinical Research
West Point, Utah, 84015
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103
Florida Medical Clinic, PA
Zephyrhills, Florida, 33542
About this study
Official title: Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
The purpose of this study is to evaluate the long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant.
Read the detailed description
The objective of this study is to determine the tolerability and safety of OraVescent fentanyl when used long term to relieve breakthrough pain in opioid tolerant cancer patients.
- Being tested
- OraVescent fentanyl citrate
- Keywords
- Cancer, Pain
- Medical subject headings
- Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraVescent fentanyl citrateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability and safety of OraVescent fentanyl when used long-term
Secondary outcomes (2)
Assess the effectiveness of OraVescent fentanyl
Assess the development of incremental tolerance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2005 (estimated)
- Study startApr 2004
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 300 participants
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105937
- Sponsor's protocol ID
- 099-15
- Status last verified
- May 2007
- First submitted
- 18 Mar 2005
- Last updated
- 29 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
- ClinicalTrials.gov ID
- NCT00105937
- Acronym / sponsor ID
- 099-15
- Keywords
- Cancer, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Nov 2006
- First posted
- 21 Mar 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 long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant.
Detailed description
The objective of this study is to determine the tolerability and safety of OraVescent fentanyl when used long term to relieve breakthrough pain in opioid tolerant cancer patients.
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 (4 listed)
- 18-80 years of age
- Average of 1-4 breakthrough pain episodes per day
- Opioid tolerant
- Histologically documented diagnosis of a malignant solid tumor or hematological malignancy
Key exclusion criteria (4 listed)
- Primary breakthrough pain is not related to cancer in any way
- Opioid or fentanyl intolerance
- Chronic obstructive pulmonary disease (COPD) or heart disease
- Sleep apnea or active brain metastases with increased cranial pressure
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 citrate | Drug | – |
Primary outcome
Tolerability and safety of OraVescent fentanyl when used long-term
2 secondary outcomes
Assess the effectiveness of OraVescent fentanyl
Assess the development of incremental tolerance
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 29 Jun 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
43 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 citrate in people with Pain and Cancer, run by Cephalon at 43 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 4 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 29 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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?
Tolerability and safety of OraVescent fentanyl when used long-term. 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 29 Jun 2012.