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| Tracking Information | |||||
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| First Received Date ICMJE | October 1, 2007 | ||||
| Last Updated Date | November 14, 2007 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
The primary objective is to assess the safety of Fentanyl SL Spray in subjects on efficacious doses of Fentanyl SL Spray [ Time Frame: 90 days ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00538863 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Tolerability Acceptability [ Time Frame: 90 days ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Long Term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain | ||||
| Official Title ICMJE | Open-Label Multi-Center Safety Trial of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain | ||||
| Brief Summary | The purpose of this study is to assess up to 90 days the safety of Fentanyl SL Spray for the treatment of breakthrough cancer pain in subjects on around-the-clock opioids for their persistent cancer pain |
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| Detailed Description | This is an open-label multi-center study of the safety of Fentanyl SL Spray as a treatment for breakthrough cancer pain. The study medication is administered under the tongue as a simple spray and can be self-administered by subjects or assisted by their caregivers. In addition, there is a questionnaire assessing satisfaction with the treatment. A total of 300 opioid-treated subjects will be enrolled. Subjects may enter this study by one of two routes:
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Supportive Care, Open Label, Single Group Assignment, Safety Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Fentanyl Sublingual Spray | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 225 | ||||
| Estimated Completion Date | March 2009 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: All subjects who have completed the Double-blind period and final visit of protocol INS-05-001, Multicenter Randomized Double-blind Trial of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain are eligible for participation in INS-06-007 as an open-label extension study. All de novo subjects must meet all of the following criteria to be eligible for participation in the study:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00538863 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | INS-06-007 | ||||
| Study Sponsor ICMJE | Insys Therapeutics Inc | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Insys Therapeutics Inc | ||||
| 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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