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Sponsored by: |
Insys Therapeutics Inc |
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Information provided by: | Insys Therapeutics Inc |
ClinicalTrials.gov Identifier: | NCT00538863 |
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
Condition | Intervention | Phase |
---|---|---|
Cancer Pain |
Drug: Fentanyl Sublingual Spray |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label, Single Group Assignment, Safety Study |
Official Title: | Open-Label Multi-Center Safety Trial of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain |
Estimated Enrollment: | 225 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | March 2009 |
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:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Contact: Lauryann Aldon | 800 365-9610 ext 333 | laldon@clinimetrics.com |
United States, California | |
Multiple sites | Recruiting |
United States, California, United States, 00000 |
Study Director: | Ellen G. Feigal, MD | Chief Medical Officer, Insys Therapeutics Inc |
Study ID Numbers: | INS-06-007 |
Study First Received: | October 1, 2007 |
Last Updated: | November 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00538863 |
Health Authority: | United States: Food and Drug Administration |
Fentanyl Pain |
Anesthetics, Intravenous Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Narcotics Pharmacologic Actions Adjuvants, Anesthesia |
Sensory System Agents Anesthetics, General Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |