PainPhase 3NCT00105287
Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
A Phase 3 study testing OraVescent fentanyl (OVF) in people with Pain and Cancer, run by Cephalon at 26 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl when used long-term to relieve breakthrough pain in opioid tolerant cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- OraVescent fentanyl (OVF)
- How many people
- 100 participants
- Where
- 26 sitesUnited States
- Study dates
- Jan 2005to Sep 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
- Documented diagnosis of a malignant solid tumor or hematological malignancy causing cancer related pain
- Currently taking around the clock opioid therapy for pain
- Experience on average, 1-4 breakthrough pain episodes per day
Who cannot join
- Opioid or fentanyl intolerance
- Sleep apnea or active brain metastases with increased intracranial pressure
- COPD (chronic obstructive pulmonary disease); cardiopulmonary disease; heart disease
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Advanced Clinical Research Institute
Anaheim, California, 92801
Pacific Cancer Medical Center
Anaheim, California, 92801
Gabrail Cancer Center
Canton, Ohio, 44718
Charleston Hematology Oncology, PA
Charleston, South Carolina, 29403
Compassionate Cancer Care Medical Group
Corona, California, 92882
Cullman Oncology and Hematology
Cullman, Alabama, 35058
Iowa Pain Management Clinic, PC
Des Moines, Iowa, 50265
Compassionate Cancer Center
Fountain Valley, California, 92708
Donald Berdeaux
Great Falls, Montana, 59405
Great Falls Clinic, LLP
Great Falls, Montana, 59405
Brody School of Medicine
Greenville, North Carolina, 27858
Southern Nevada Cancer Research
Las Vegas, Nevada, 89106
Center for Prospective Outcome
Marietta, Georgia, 30060
Lovelace Scientific Resources
Miami, Florida, 33143
Clinical Trials & Research Associates, Inc.
Montebello, California, 90640
NYU Pain Management Center
New York, New York, 10016
Research Across America
New York, New York, 10021
Gulf Coast Pain Specialists
Pensacola, Florida, 32503
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, 34952
Lifetree Clinical Research
Salt Lake City, Utah, 84106
University of Rochester
San Antonio, Texas, 78229
San Diego Hospice & Palliative Care
San Diego, California, 92103
Pacific Clinical Research
Santa Monica, California, 90404
Cache Valley Cancer Treatment and Research Clinic, Inc.
West Point, Utah, 84015
About this study
Official title: Multi-center Study Evaluating OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl when used long-term to relieve breakthrough pain in opioid tolerant cancer patients.
- Being tested
- OraVescent fentanyl (OVF)
- Keywords
- cancer, pain, Breakthrough Pain in cancer patients
- 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 (OVF)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2005 (estimated)
- Study startJan 2005
- Primary completionSep 2006
- Study completionSep 2007
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
- 100 participants
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105287
- Sponsor's protocol ID
- C25608/3039/BP/US
- Status last verified
- May 2014
- First submitted
- 11 Mar 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
- Multi-center Study Evaluating OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
- ClinicalTrials.gov ID
- NCT00105287
- Acronym / sponsor ID
- C25608/3039/BP/US
- Keywords
- cancer, pain, Breakthrough Pain in cancer patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 14 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 safety and tolerability 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 (3 listed)
- Documented diagnosis of a malignant solid tumor or hematological malignancy causing cancer related pain
- Currently taking around the clock opioid therapy for pain
- Experience on average, 1-4 breakthrough pain episodes per day
Key exclusion criteria (3 listed)
- Opioid or fentanyl intolerance
- Sleep apnea or active brain metastases with increased intracranial pressure
- COPD (chronic obstructive pulmonary disease); cardiopulmonary disease; heart disease
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 (OVF) | Drug | – |
Primary outcome
Not reported in the source record.
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.
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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.
26 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 (OVF) in people with Pain and Cancer, run by Cephalon at 26 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 3 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 26 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.
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.