Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years
- Registration Number
- NCT00994760
- Lead Sponsor
- Takeda
- Brief Summary
The aim of the study was to evaluate the safety and efficacy of intranasal fentanyl spray in cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP) attacks. The fentanyl spray was applied into the nose by a metered-spray device. The study was to provide further data on pharmacoeconomic efficiency of intranasal fentanyl spray.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description GENISIS Instanyl (Intranasal Fentanyl) -
- Primary Outcome Measures
Name Time Method Dose of Instanyl during therapy with Instanyl (planned: 28 days) Initially prescribed dose/ most efficient single dose of Instanyl at study end
Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination before and after therapy with Instanyl (first/last visit) Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme
Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) before and after therapy with Instanyl (first/last visit) Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit) after therapy with Instanyl (planned: 4 weeks) 5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all
Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) after therapy with Instanyl (at last visit) Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened
Physician: What is the Current Treatment Needs of Your Patient Regarding ... before and after therapy with Instanyl (first/last visit) Scale: 0=no, 1=low, 2=medium, 3=high
- Secondary Outcome Measures
Name Time Method Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End after therapy with Instanyl (planned: 4 weeks) 0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
Patient: How Many Episodes of Pain You Experience on Average? initial visit (before start of therapy with Instanyl) Patient: Description of Pain at Initial Visit initial visit (before start of therapy with Instanyl) 0=no pain, 10= most intense pain imaginable
Patient: How do You Feel Today? before and after therapy with Instanyl (first/last visit) Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good
Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks? before and after therapy with Instanyl (first/last visit) Scale: 0=not at all, 10=completely
Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only) before and after therapy with Instanyl (first/last visit) Scale: 0=no impairment, 70=complete impairment
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) before and after therapy with Instanyl (first/last visit) Scale: 0=complete impairment, 43=no impairment
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20 before and after therapy with Instanyl (first/last visit) 0= conspicuous ≤20
1= inconspicuous \>20Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) before and after therapy with Instanyl (first/last visit) Scale: 0=worst, 5=best
Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5 before and after therapy with Instanyl (first/last visit) conspicuous score \<1.5 inconspicuous score ≥1.5
Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End after therapy with Instanyl (planned: 4 weeks) 0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) before and after therapy with Instanyl (first/last visit) Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit) after therapy with Instanyl (planned: 4 weeks) 5=completely, 4=for the most part, 3=partially, 2=more or less, 1=rather not, 0=not at all
Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit) after therapy with Instanyl (at last visit) Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened
Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End after therapy with Instanyl (planned: 4 weeks) 0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit) after therapy with Instanyl (first/last visit) Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) after therapy with Instanyl (at last visit) Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... after therapy with Instanyl (last visit) Scale: -3= very much less, -2= much less, -1= less, 0=comparable, 1= more, 2= much more, 3= very much more
Trial Locations
- Locations (1)
Nycomed Deutschland GmbH
🇩🇪Zwönitz, Germany