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Trial record 2 of 56 for:    insys

Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis

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ClinicalTrials.gov Identifier: NCT00956254
Recruitment Status : Completed
First Posted : August 11, 2009
Results First Posted : September 5, 2013
Last Update Posted : September 5, 2013
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Mucositis
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Intervention Drug: Fentanyl sublingual spray
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fentanyl Sublingual Spray 100 µg
Hide Arm/Group Description Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
Period Title: Overall Study
Started 18
Completed 18
Not Completed 0
Arm/Group Title Fentanyl Sublingual Spray 100 µg
Hide Arm/Group Description Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
Safety population: All subjects who received study drug.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
46.6  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
10
  55.6%
Male
8
  44.4%
1.Primary Outcome
Title Cmax of Fentanyl
Hide Description Cmax is defined as the maximum drug concentration in plasma and was determined from individual plasma concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.
Time Frame Pre-dose to 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population: All subjects who had evaluable plasma profiles to calculate reliable estimates of PK parameters and who had no major protocol deviations. One subject in the non-mucositis group self-administered a fentanyl product before receiving the study drug and was excluded from the PK population due to this protocol deviation.
Arm/Group Title Fentanyl Sublingual Spray 100 µg - Mucositis Fentanyl Sublingual Spray 100 µg - Non-mucositis
Hide Arm/Group Description:
Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.67  (0.60) 0.26  (0.15)
2.Secondary Outcome
Title Tmax of Fentanyl
Hide Description Tmax is defined as the time to reach the maximum concentration of fentanyl in plasma and was determined from individual concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; and 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.
Time Frame Pre-dose to 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population: All subjects who had evaluable plasma profiles to calculate reliable estimates of PK parameters and who had no major protocol deviations. One subject in the non-mucositis group self-administered a fentanyl product before receiving the study drug and was excluded from the PK population due to this protocol deviation.
Arm/Group Title Fentanyl Sublingual Spray 100 µg - Mucositis Fentanyl Sublingual Spray 100 µg - Non-mucositis
Hide Arm/Group Description:
Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: hr
0.53  (0.57) 0.56  (0.59)
3.Secondary Outcome
Title AUC0-last of Fentanyl
Hide Description AUC0-last is defined as the area under the plasma concentration-time curve from time-zero to the time of the last quantifiable concentration of fentanyl, was calculated using the linear trapezoidal rule, and was determined from individual concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; and 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.
Time Frame Pre-dose to 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic evaluable population: All subjects who had evaluable plasma profiles to calculate reliable estimates of pharmacokinetic parameters and who had no major protocol deviations.
Arm/Group Title Fentanyl Sublingual Spray 100 µg - Mucositis Fentanyl Sublingual Spray 100 µg - Non-mucositis
Hide Arm/Group Description:
Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
3.11  (4.80) 0.91  (0.13)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population: All subjects who received study drug.
 
Arm/Group Title Fentanyl Sublingual Spray 100 µg - Mucositis Fentanyl Sublingual Spray 100 µg - Non-mucositis
Hide Arm/Group Description Participants received a single administration of fentanyl sublingual spray 100 µg sublingually. Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
All-Cause Mortality
Fentanyl Sublingual Spray 100 µg - Mucositis Fentanyl Sublingual Spray 100 µg - Non-mucositis
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fentanyl Sublingual Spray 100 µg - Mucositis Fentanyl Sublingual Spray 100 µg - Non-mucositis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fentanyl Sublingual Spray 100 µg - Mucositis Fentanyl Sublingual Spray 100 µg - Non-mucositis
Affected / at Risk (%) Affected / at Risk (%)
Total   2/9 (22.22%)   0/9 (0.00%) 
General disorders     
Burning sensation mucosal  1  2/9 (22.22%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Larry Dillaha, M.D., Chief Medical Officer
Organization: Insys Therapeutics, Inc.
Phone: 602 910-2617
Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT00956254     History of Changes
Other Study ID Numbers: INS-09-011
CDR0000647007 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: August 8, 2009
First Posted: August 11, 2009
Results First Submitted: June 25, 2013
Results First Posted: September 5, 2013
Last Update Posted: September 5, 2013