Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain
This study has been completed.
Sponsor:
Cephalon
Information provided by:
Cephalon
ClinicalTrials.gov Identifier:
NCT00228605
First received: September 27, 2005
Last updated: November 9, 2007
Last verified: November 2007
| Tracking Information | |||||
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| First Received Date ICMJE | September 27, 2005 | ||||
| Last Updated Date | November 9, 2007 | ||||
| Start Date ICMJE | March 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients | ||||
| Original Primary Outcome Measures ICMJE |
Safety & Tolerability when used over a 12-monthperiod for the maagement of breakthrough pain in opioid tolerant patients | ||||
| Change History | Complete list of historical versions of study NCT00228605 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain | ||||
| Official Title ICMJE | 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 | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: OraVescent Fentanyl | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 500 | ||||
| Completion Date | May 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00228605 | ||||
| Other Study ID Numbers ICMJE | C25608/3040/BP/US | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Cephalon | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Cephalon | ||||
| Verification Date | November 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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