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Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain

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ClinicalTrials.gov Identifier: NCT00538850
Recruitment Status : Completed
First Posted : October 3, 2007
Results First Posted : March 5, 2014
Last Update Posted : March 5, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Study Type Interventional
Study Design Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cancer
Interventions Drug: Fentanyl sublingual spray
Drug: Placebo
Enrollment 130
Recruitment Details  
Pre-assignment Details As there are dozens, if not hundreds, of cross-over sequences during the double-blind period of this study, instead of reporting participant flow for each of the cross-over sequences, participant flow is reported separately for the fentanyl and placebo groups.
Arm/Group Title Fentanyl Sublingual Spray - Titration Fentanyl Sublingual Spray - Double-blind Placebo - Double-blind
Hide Arm/Group Description In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached. Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study. Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
Period Title: Titration Period
Started 130 0 [1] 0 [1]
Completed 98 0 0
Not Completed 32 0 0
[1]
There were no participants in this reporting group in the titration period.
Period Title: Fentanyl Sublingual Spray - Double-blind
Started 0 [1] 98 0 [1]
Completed 0 95 0
Not Completed 0 3 0
[1]
There were no participants in this reporting group in the double-blind period.
Period Title: Placebo - Double-blind
Started 0 [1] 0 [1] 98
Completed 0 0 95
Not Completed 0 0 3
[1]
There were no participants in this reporting group in the double-blind period.
Arm/Group Title Fentanyl Sublingual Spray
Hide Arm/Group Description Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
Overall Number of Baseline Participants 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants
55.6  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants
Female
69
  53.1%
Male
61
  46.9%
1.Primary Outcome
Title Summed Pain Intensity Differences (SPID) at 30 Minutes After Dosing (SPID30)
Hide Description Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented “no pain” and 100 represented “worst possible pain” at 0 (baseline, beginning of the pain episode), 5, 10, 15, and 30 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID30 was calculated as the time-weighted sum of the PID scores using the following formula: SPID30=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30). The minimum and maximum SPID30 scores were -3000 and 3000. A higher score indicates less pain.
Time Frame Baseline (time 0, beginning of each pain episode) through 30 minutes after dosing for each pain episode
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.
Arm/Group Title Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:
Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
Overall Number of Participants Analyzed 92 92
Mean (Standard Deviation)
Unit of Measure: Units on a scale
640.3  (458.8) 399.6  (391.2)
2.Secondary Outcome
Title Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing
Hide Description Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented “no pain” and 100 represented “worst possible pain” at 0 (baseline, beginning of the pain episode), 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID was calculated as the time-weighted sum of the PID scores using the following formulas: SPID5=(5*PID5), SPID10=(5*PID5)+(5*PID10), SPID15=(5*PID5)+(5*PID10)+(5*PID15), SPID30=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30), SPID45=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30)+(15*PID45), SPID60=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30) +(15*PID45) +(15*PID60). The minimum and maximum SPID scores were -500 to 500, -1000 to 1000, -1500 to 1500, -3000 to 3000, -4500 to 4500, and -6000 to 6000, respectively. A higher score indicates less pain.
Time Frame Baseline (time 0, beginning of each pain episode) through 60 minutes after dosing for each pain episode
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.
Arm/Group Title Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:
Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
Overall Number of Participants Analyzed 92 92
Mean (Standard Deviation)
Unit of Measure: Units on a scale
SPID5 40.3  (57.7) 32.0  (52.1)
SPID10 115.0  (130.7) 81.1  (108.0)
SPID15 220.6  (209.7) 150.3  (172.5)
SPID45 1122.0  (731.9) 667.0  (614.5)
SPID60 1649.0  (1016.2) 965.7  (862.1)
3.Secondary Outcome
Title Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing
Hide Description Pain relief (PAR) was assessed by the participant on a 5-point scale (1=No relief, 2=A little relief, 3=Moderate relief, 4=A lot of relief, 5=Complete relief) at 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. TOTPAR was calculated as the time-weighted sum of the PAR scores at each time point using the following formulas: TOTPAR5=(5*PAR5), TOTPAR10=(5*PAR5)+(5*PAR10), TOTPAR15=(5*PAR5)+(5*PAR10)+(5*PAR15), TOTPAR30=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30), TOTPAR45=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30)+(15*PAR45), TOTPAR60=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30) +(15*PAR45) +(15*PAR60). The minimum and maximum TOTPAR5, TOTPAR10, TOTPAR15, TOTPAR30, TOTPAR45, and TOTPAR60 scores were 5 to 25, 10 to 50, 15 to 75, 30 to 150, 45 to 225, and 60 to 300, respectively. A higher score indicates more pain relief.
Time Frame 5 through 60 minutes after dosing for each pain episode
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.
Arm/Group Title Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:
Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
Overall Number of Participants Analyzed 92 92
Mean (Standard Deviation)
Unit of Measure: Units on a scale
TOTPAR5 8.6  (3.5) 7.6  (3.3)
TOTPAR10 19.7  (7.0) 16.7  (6.5)
TOTPAR15 32.9  (10.3) 27.1  (10.0)
TOTPAR30 78.3  (20.4) 61.0  (20.8)
TOTPAR45 126.3  (30.9) 95.5  (32.0)
TOTPAR60 176.4  (41.5) 131.2  (43.6)
4.Secondary Outcome
Title Global Evaluation of the Study Medication at 30 and 60 Minutes After Dosing
Hide Description Global evaluation of the study medication was assessed by the participant on a 5-point scale (1=Poor, 2=Fair, 3=Good, 4=Very good, 5=Excellent) at 30 and 60 minutes after each dose of study medication during each breakthrough pain episode. A higher score indicates a better evaluation.
Time Frame 30 through 60 minutes after dosing for each pain episode
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.
Arm/Group Title Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:
Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
Overall Number of Participants Analyzed 92 92
Mean (Standard Deviation)
Unit of Measure: Units on a scale
30 minutes 2.8  (0.8) 2.0  (0.8)
60 minutes 3.1  (0.8) 2.2  (0.8)
Time Frame All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Adverse Event Reporting Description

Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray.

As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.

 
Arm/Group Title Fentanyl Sublingual Spray - Titration Fentanyl Sublingual Spray - Double-blind
Hide Arm/Group Description In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached. Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
All-Cause Mortality
Fentanyl Sublingual Spray - Titration Fentanyl Sublingual Spray - Double-blind
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fentanyl Sublingual Spray - Titration Fentanyl Sublingual Spray - Double-blind
Affected / at Risk (%) Affected / at Risk (%)
Total   7/130 (5.38%)   6/98 (6.12%) 
Blood and lymphatic system disorders     
Leukopenia  1  1/130 (0.77%)  0/98 (0.00%) 
Cardiac disorders     
Tachycardia  1  0/130 (0.00%)  1/98 (1.02%) 
Gastrointestinal disorders     
Abdominal pain  1  1/130 (0.77%)  1/98 (1.02%) 
Nausea  1  1/130 (0.77%)  1/98 (1.02%) 
Vomiting  1  1/130 (0.77%)  1/98 (1.02%) 
Infections and infestations     
Cellulitis  1  1/130 (0.77%)  1/98 (1.02%) 
Gastroenteritis Viral  1  0/130 (0.00%)  1/98 (1.02%) 
Metabolism and nutrition disorders     
Hyponatraemia  1  1/130 (0.77%)  0/98 (0.00%) 
Musculoskeletal and connective tissue disorders     
Fistula  1  1/130 (0.77%)  0/98 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung cancer metastatic  1  1/130 (0.77%)  0/98 (0.00%) 
Malignant neoplasm progression  1  1/130 (0.77%)  1/98 (1.02%) 
Metastases to bone  1  1/130 (0.77%)  0/98 (0.00%) 
Spinal cord neoplasm  1  1/130 (0.77%)  0/98 (0.00%) 
Nervous system disorders     
Paraplegia  1  0/130 (0.00%)  1/98 (1.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fentanyl Sublingual Spray - Titration Fentanyl Sublingual Spray - Double-blind
Affected / at Risk (%) Affected / at Risk (%)
Total   78/130 (60.00%)   47/98 (47.96%) 
Blood and lymphatic system disorders     
Anaemia  1  1/130 (0.77%)  2/98 (2.04%) 
Leukopenia  1  1/130 (0.77%)  0/98 (0.00%) 
Lymphadenopathy  1  1/130 (0.77%)  0/98 (0.00%) 
Pancytopenia  1  0/130 (0.00%)  1/98 (1.02%) 
Cardiac disorders     
Tachycardia  1  1/130 (0.77%)  1/98 (1.02%) 
Right ventricular hypertrophy  1  0/130 (0.00%)  1/98 (1.02%) 
Sinus tachycardia  1  0/130 (0.00%)  1/98 (1.02%) 
Ear and labyrinth disorders     
Ear pain  1  1/130 (0.77%)  0/98 (0.00%) 
Vertigo  1  1/130 (0.77%)  0/98 (0.00%) 
Eye disorders     
Dry eye  1  1/130 (0.77%)  0/98 (0.00%) 
Gastrointestinal disorders     
Nausea  1  17/130 (13.08%)  7/98 (7.14%) 
Vomiting  1  10/130 (7.69%)  4/98 (4.08%) 
Diarrhoea  1  7/130 (5.38%)  3/98 (3.06%) 
Constipation  1  5/130 (3.85%)  0/98 (0.00%) 
Stomatitis  1  5/130 (3.85%)  1/98 (1.02%) 
Dry mouth  1  2/130 (1.54%)  2/98 (2.04%) 
Abdominal discomfort  1  1/130 (0.77%)  0/98 (0.00%) 
Abdominal distension  1  1/130 (0.77%)  0/98 (0.00%) 
Abdominal pain  1  1/130 (0.77%)  1/98 (1.02%) 
Abdominal pain upper  1  1/130 (0.77%)  0/98 (0.00%) 
Dysphagia  1  1/130 (0.77%)  0/98 (0.00%) 
Flatulence  1  1/130 (0.77%)  1/98 (1.02%) 
Gastric ulcer  1  1/130 (0.77%)  0/98 (0.00%) 
Gastrointestinal motility disorder  1  1/130 (0.77%)  0/98 (0.00%) 
Gingival hyperplasia  1  1/130 (0.77%)  0/98 (0.00%) 
Glossitis  1  1/130 (0.77%)  0/98 (0.00%) 
Hyperchlorhydria  1  1/130 (0.77%)  0/98 (0.00%) 
Hypoaesthesia oral  1  1/130 (0.77%)  0/98 (0.00%) 
Odynophagia  1  1/130 (0.77%)  0/98 (0.00%) 
Oral pain  1  1/130 (0.77%)  0/98 (0.00%) 
Retching  1  1/130 (0.77%)  1/98 (1.02%) 
Tongue ulceration  1  1/130 (0.77%)  0/98 (0.00%) 
Abdominal pain lower  1  0/130 (0.00%)  2/98 (2.04%) 
Aphthous stomatitis  1  0/130 (0.00%)  1/98 (1.02%) 
Ascites  1  0/130 (0.00%)  1/98 (1.02%) 
Colitis  1  0/130 (0.00%)  1/98 (1.02%) 
Lip disorder  1  0/130 (0.00%)  1/98 (1.02%) 
Oral mucosal discolouration  1  0/130 (0.00%)  1/98 (1.02%) 
Salivary gland enlargement  1  0/130 (0.00%)  1/98 (1.02%) 
General disorders     
Pyrexia  1  8/130 (6.15%)  1/98 (1.02%) 
Oedema peripheral  1  7/130 (5.38%)  5/98 (5.10%) 
Asthenia  1  4/130 (3.08%)  2/98 (2.04%) 
Fatigue  1  4/130 (3.08%)  2/98 (2.04%) 
Application site irritation  1  3/130 (2.31%)  0/98 (0.00%) 
Adverse drug reaction  1  1/130 (0.77%)  0/98 (0.00%) 
Catheter related complication  1  1/130 (0.77%)  0/98 (0.00%) 
Catheter site erythema  1  1/130 (0.77%)  0/98 (0.00%) 
Chest discomfort  1  1/130 (0.77%)  1/98 (1.02%) 
Feeling abnormal  1  1/130 (0.77%)  0/98 (0.00%) 
Localised oedema  1  1/130 (0.77%)  0/98 (0.00%) 
Mucosal inflammation  1  1/130 (0.77%)  0/98 (0.00%) 
Pain  1  1/130 (0.77%)  1/98 (1.02%) 
Thirst  1  1/130 (0.77%)  0/98 (0.00%) 
Chills  1  0/130 (0.00%)  1/98 (1.02%) 
Malaise  1  0/130 (0.00%)  1/98 (1.02%) 
Mass  1  0/130 (0.00%)  1/98 (1.02%) 
Hepatobiliary disorders     
Jaundice cholestatic  1  1/130 (0.77%)  0/98 (0.00%) 
Infections and infestations     
Urinary tract infection  1  5/130 (3.85%)  3/98 (3.06%) 
Cellulitis  1  2/130 (1.54%)  1/98 (1.02%) 
Gastroenteritis viral  1  1/130 (0.77%)  1/98 (1.02%) 
Oral herpes  1  1/130 (0.77%)  0/98 (0.00%) 
Pneumonia  1  1/130 (0.77%)  1/98 (1.02%) 
Pyelonephritis  1  1/130 (0.77%)  0/98 (0.00%) 
Upper respiratory tract infection  1  1/130 (0.77%)  0/98 (0.00%) 
Viral upper respiratory tract infection  1  1/130 (0.77%)  0/98 (0.00%) 
Candidiasis  1  0/130 (0.00%)  1/98 (1.02%) 
Extradural abscess  1  0/130 (0.00%)  1/98 (1.02%) 
Fungal infection  1  0/130 (0.00%)  1/98 (1.02%) 
Nasopharyngitis  1  0/130 (0.00%)  1/98 (1.02%) 
Oral viral infection  1  0/130 (0.00%)  1/98 (1.02%) 
Pharyngitis  1  0/130 (0.00%)  1/98 (1.02%) 
Sinusitis  1  0/130 (0.00%)  1/98 (1.02%) 
Injury, poisoning and procedural complications     
Fall  1  2/130 (1.54%)  0/98 (0.00%) 
Contusion  1  1/130 (0.77%)  0/98 (0.00%) 
Device breakage  1  1/130 (0.77%)  0/98 (0.00%) 
Excoriation  1  1/130 (0.77%)  0/98 (0.00%) 
Radiation injury  1  1/130 (0.77%)  1/98 (1.02%) 
Radiation mucositis  1  0/130 (0.00%)  1/98 (1.02%) 
Investigations     
Blood bilirubin increased  1  1/130 (0.77%)  0/98 (0.00%) 
Blood creatinine increased  1  1/130 (0.77%)  0/98 (0.00%) 
Blood glucose increased  1  1/130 (0.77%)  0/98 (0.00%) 
Blood potassium decreased  1  1/130 (0.77%)  1/98 (1.02%) 
Blood urea increased  1  1/130 (0.77%)  0/98 (0.00%) 
International normalised ratio increased  1  1/130 (0.77%)  0/98 (0.00%) 
Prothrombin time prolonged  1  1/130 (0.77%)  0/98 (0.00%) 
Breath sounds abnormal  1  0/130 (0.00%)  1/98 (1.02%) 
Electrocardiogram Qrs complex abnormal  1  0/130 (0.00%)  1/98 (1.02%) 
Weight decreased  1  0/130 (0.00%)  1/98 (1.02%) 
Weight increased  1  0/130 (0.00%)  1/98 (1.02%) 
Metabolism and nutrition disorders     
Anorexia  1  2/130 (1.54%)  0/98 (0.00%) 
Dehydration  1  2/130 (1.54%)  0/98 (0.00%) 
Decreased appetite  1  1/130 (0.77%)  0/98 (0.00%) 
Hypokalaemia  1  1/130 (0.77%)  0/98 (0.00%) 
Hyponatraemia  1  1/130 (0.77%)  0/98 (0.00%) 
Increased appetite  1  1/130 (0.77%)  0/98 (0.00%) 
Malnutrition  1  1/130 (0.77%)  0/98 (0.00%) 
Glucose tolerance impaired  1  0/130 (0.00%)  1/98 (1.02%) 
Hypomagnesaemia  1  0/130 (0.00%)  1/98 (1.02%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  3/130 (2.31%)  1/98 (1.02%) 
Arthralgia  1  2/130 (1.54%)  1/98 (1.02%) 
Fistula  1  2/130 (1.54%)  0/98 (0.00%) 
Joint swelling  1  2/130 (1.54%)  0/98 (0.00%) 
Limb discomfort  1  1/130 (0.77%)  0/98 (0.00%) 
Mobility decreased  1  1/130 (0.77%)  0/98 (0.00%) 
Muscle spasms  1  1/130 (0.77%)  0/98 (0.00%) 
Pain in extremity  1  0/130 (0.00%)  2/98 (2.04%) 
Bone pain  1  0/130 (0.00%)  1/98 (1.02%) 
Flank pain  1  0/130 (0.00%)  1/98 (1.02%) 
Muscular weakness  1  0/130 (0.00%)  1/98 (1.02%) 
Myalgia  1  0/130 (0.00%)  1/98 (1.02%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression  1  3/130 (2.31%)  1/98 (1.02%) 
Cancer pain  1  1/130 (0.77%)  0/98 (0.00%) 
Lung cancer metastatic  1  1/130 (0.77%)  0/98 (0.00%) 
Metastases to bone  1  1/130 (0.77%)  0/98 (0.00%) 
Spinal cord neoplasm  1  1/130 (0.77%)  0/98 (0.00%) 
Neoplasm  1  0/130 (0.00%)  1/98 (1.02%) 
Polycythaemia vera  1  0/130 (0.00%)  1/98 (1.02%) 
Nervous system disorders     
Somnolence  1  11/130 (8.46%)  2/98 (2.04%) 
Dizziness  1  10/130 (7.69%)  2/98 (2.04%) 
Headache  1  5/130 (3.85%)  3/98 (3.06%) 
Sedation  1  4/130 (3.08%)  0/98 (0.00%) 
Dysgeusia  1  3/130 (2.31%)  0/98 (0.00%) 
Lethargy  1  2/130 (1.54%)  0/98 (0.00%) 
Areflexia  1  1/130 (0.77%)  0/98 (0.00%) 
Balance disorder  1  1/130 (0.77%)  0/98 (0.00%) 
Burning sensation  1  1/130 (0.77%)  0/98 (0.00%) 
Disturbance In attention  1  1/130 (0.77%)  0/98 (0.00%) 
Dyskinesia  1  1/130 (0.77%)  0/98 (0.00%) 
Facial palsy  1  1/130 (0.77%)  0/98 (0.00%) 
Hyperreflexia  1  1/130 (0.77%)  0/98 (0.00%) 
Hypoaesthesia  1  1/130 (0.77%)  0/98 (0.00%) 
Paraesthesia  1  1/130 (0.77%)  0/98 (0.00%) 
Neuralgia  1  0/130 (0.00%)  1/98 (1.02%) 
Paraplegia  1  0/130 (0.00%)  1/98 (1.02%) 
Spinal cord disorder  1  0/130 (0.00%)  1/98 (1.02%) 
Psychiatric disorders     
Confusional state  1  4/130 (3.08%)  0/98 (0.00%) 
Insomnia  1  4/130 (3.08%)  1/98 (1.02%) 
Agitation  1  2/130 (1.54%)  0/98 (0.00%) 
Hallucination  1  2/130 (1.54%)  0/98 (0.00%) 
Anxiety  1  1/130 (0.77%)  1/98 (1.02%) 
Depression  1  1/130 (0.77%)  0/98 (0.00%) 
Disorientation  1  1/130 (0.77%)  0/98 (0.00%) 
Mood swings  1  1/130 (0.77%)  0/98 (0.00%) 
Paranoia  1  1/130 (0.77%)  0/98 (0.00%) 
Restlessness  1  1/130 (0.77%)  0/98 (0.00%) 
Euphoric mood  1  0/130 (0.00%)  1/98 (1.02%) 
Nervousness  1  0/130 (0.00%)  1/98 (1.02%) 
Renal and urinary disorders     
Urinary retention  1  3/130 (2.31%)  0/98 (0.00%) 
Bladder distension  1  1/130 (0.77%)  0/98 (0.00%) 
Bladder spasm  1  1/130 (0.77%)  0/98 (0.00%) 
Haematuria  1  1/130 (0.77%)  0/98 (0.00%) 
Micturition urgency  1  1/130 (0.77%)  0/98 (0.00%) 
Renal impairment  1  0/130 (0.00%)  1/98 (1.02%) 
Urinary incontinence  1  0/130 (0.00%)  1/98 (1.02%) 
Reproductive system and breast disorders     
Amenorrhoea  1  1/69 (1.45%)  0/98 (0.00%) 
Epididymitis  1  1/61 (1.64%)  0/98 (0.00%) 
Vaginal haemorrhage  1  1/69 (1.45%)  0/98 (0.00%) 
Vaginal ulceration  1  0/130 (0.00%)  1/98 (1.02%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  4/130 (3.08%)  0/98 (0.00%) 
Cough  1  3/130 (2.31%)  3/98 (3.06%) 
Increased bronchial secretion  1  3/130 (2.31%)  0/98 (0.00%) 
Dysphonia  1  1/130 (0.77%)  0/98 (0.00%) 
Epistaxis  1  1/130 (0.77%)  1/98 (1.02%) 
Hiccups  1  1/130 (0.77%)  0/98 (0.00%) 
Increased upper airway secretion  1  1/130 (0.77%)  0/98 (0.00%) 
Pharyngolaryngeal pain  1  1/130 (0.77%)  0/98 (0.00%) 
Pulmonary congestion  1  1/130 (0.77%)  0/98 (0.00%) 
Respiratory tract congestion  1  1/130 (0.77%)  0/98 (0.00%) 
Throat irritation  1  1/130 (0.77%)  0/98 (0.00%) 
Wheezing  1  1/130 (0.77%)  1/98 (1.02%) 
Pharyngeal inflammation  1  0/130 (0.00%)  1/98 (1.02%) 
Productive cough  1  0/130 (0.00%)  1/98 (1.02%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  2/130 (1.54%)  5/98 (5.10%) 
Alopecia  1  1/130 (0.77%)  0/98 (0.00%) 
Blister  1  1/130 (0.77%)  0/98 (0.00%) 
Erythema  1  1/130 (0.77%)  0/98 (0.00%) 
Pruritus  1  1/130 (0.77%)  0/98 (0.00%) 
Rash  1  1/130 (0.77%)  0/98 (0.00%) 
Rash erythematous  1  1/130 (0.77%)  0/98 (0.00%) 
Rash maculo-papular  1  1/130 (0.77%)  0/98 (0.00%) 
Skin lesion  1  1/130 (0.77%)  0/98 (0.00%) 
Urticaria  1  1/130 (0.77%)  0/98 (0.00%) 
Dermatitis contact  1  0/130 (0.00%)  1/98 (1.02%) 
Ecchymosis  1  0/130 (0.00%)  1/98 (1.02%) 
Rash macular  1  0/130 (0.00%)  1/98 (1.02%) 
Stasis dermatitis  1  0/130 (0.00%)  1/98 (1.02%) 
Vascular disorders     
Deep vein thrombosis  1  1/130 (0.77%)  1/98 (1.02%) 
Hypertension  1  1/130 (0.77%)  2/98 (2.04%) 
Hypotension  1  1/130 (0.77%)  0/98 (0.00%) 
Venous stasis  1  1/130 (0.77%)  0/98 (0.00%) 
Flushing  1  0/130 (0.00%)  2/98 (2.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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: NCT00538850     History of Changes
Obsolete Identifiers: NCT00589342
Other Study ID Numbers: INS-05-001
CDR0000581128 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: October 1, 2007
First Posted: October 3, 2007
Results First Submitted: May 8, 2013
Results First Posted: March 5, 2014
Last Update Posted: March 5, 2014