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Sponsored by: |
Insys Therapeutics Inc |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00538850 |
RATIONALE: Fentanyl sublingual spray may help relieve breakthrough pain in patients receiving opioids for cancer pain.
PURPOSE: This randomized phase III trial is studying how well fentanyl sublingual spray works in treating breakthrough cancer pain.
Condition | Intervention | Phase |
---|---|---|
Cancer |
Drug: fentanyl sublingual spray Procedure: questionnaire administration |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Evaluate the Safety and Efficacy of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain |
Estimated Enrollment: | 130 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual (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 patients or assisted by their caregivers. In addition, there is a questionnaire assessing satisfaction with the treatment. Patients are titrated to an effective-dose of fentanyl SL spray in the open-label titration period and then proceed to the double-blind randomized period. Patients are treated for up to a total of 6-7 weeks (including both the open-label titration and the double-blind randomized periods).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Opioid-tolerant, defined as undergoing opioid treatment for cancer-related pain for ≥ 7 days and meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Arizona | |
InSys Therapeutics, Incorporated | Recruiting |
Phoenix, Arizona, United States, 85044 | |
Contact: Lauryann Aldon 800-365-9610 ext. 333 laldon@clinimetrics.com |
Study Chair: | Ellen Feigal, MD | Insys Therapeutics Inc |
Study ID Numbers: | CDR0000581128, INSYS-INS-05-001, NCT00538850 |
Study First Received: | October 1, 2007 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00538850 |
Health Authority: | Unspecified |
gastrinoma unspecified adult solid tumor, protocol specific pain adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) stage IV chronic lymphocytic leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia chronic myelomonocytic leukemia chronic phase chronic myelogenous leukemia noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult diffuse large cell lymphoma |
noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma noncontiguous stage II small lymphocytic lymphoma noncontiguous stage II marginal zone lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II mantle cell lymphoma stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult immunoblastic large cell lymphoma |
Sezary syndrome Bone Neoplasms Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Lymphoma, large-cell, immunoblastic Lymphomatoid granulomatosis Lung Neoplasms Myelodysplastic syndromes Non-small cell lung cancer Precursor Cell Lymphoblastic Leukemia-Lymphoma Astrocytoma Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Sarcoma, Clear Cell Leukemia, Myeloid |
Urethral cancer Plasmacytoma Leukemia, Myeloid, Accelerated Phase Sarcoma Anaplastic large cell lymphoma Uterine sarcoma Gallbladder Neoplasms Esophageal Diseases Lymphoma, Non-Hodgkin Aggressive fibromatosis Anus Neoplasms Carcinoma, Non-Small-Cell Lung Hairy cell leukemia Neoplasms, Glandular and Epithelial Choroid Plexus Neoplasms |
Anesthetics, Intravenous Neoplasms by Histologic Type Immune System Diseases Neoplasms, Nerve Tissue Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Pharmacologic Actions Adjuvants, Anesthesia |
Neoplasms Anesthetics, General Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Analgesics Neoplasms, Neuroepithelial Central Nervous System Agents Analgesics, Opioid |