N/A
N=131
Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years
Breakthrough Pain · Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00994760 ↗Enrolled (actual)
131
Serious AEs
14.5%
Results posted
Sep 2012
Primary outcome: Primary: Dose of Instanyl — 75; 30; 50; 69 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Instanyl (Intranasal Fentanyl) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose of Instanyl |
75; 30; 50; 69; 5; 15 | — |
| PRIMARY Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination |
2.3; 1.6; 3.5; 1.8 | — |
| PRIMARY Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) |
4.0; 1.7; 4.0; 1.8; 3.0; 1.7 | — |
| PRIMARY Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit) |
4.4 | — |
| PRIMARY Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) |
-1.2; -1.5; -1.6; -1.5; -1.1 | — |
| PRIMARY Physician: What is the Current Treatment Needs of Your Patient Regarding ... |
2.0; 1.3; 2.5; 1.2; 1.5; 0.9 | — |
| SECONDARY Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End |
3.4 | — |
| SECONDARY Patient: How Many Episodes of Pain You Experience on Average? |
3.0 | — |
| SECONDARY Patient: Description of Pain at Initial Visit |
5.6; 8.3; 4.0 | — |
| SECONDARY Patient: How do You Feel Today? |
2.2; 3.3 | — |
| SECONDARY Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks? |
7.6; 3.8 | — |
| SECONDARY Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only) |
51.9; 29.1 | — |
| SECONDARY Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) |
12.3; 24.7 | — |
| SECONDARY Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20 |
80; 21; 13; 61; 2; 1 | — |
| SECONDARY Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) |
1.2; 2.2 | — |
| SECONDARY Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5 |
62; 24; 31; 57; 2; 2 | — |
| SECONDARY Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End |
3.4 | — |
| SECONDARY Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl) |
4.1; 2.0; 3.9; 2.0; 3.2; 2.0 | — |
| SECONDARY Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit) |
4.2; 4.2; 4.3; 4.2; 4.2 | — |
| SECONDARY Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit) |
-1.0; -1.4; -1.3; -1.4 | — |
| SECONDARY Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End |
3.3 | — |
| SECONDARY Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit) |
2.2; 2.1; 1.9; 2.0; 2.2; 2.1 | — |
| SECONDARY Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit) |
-0.8; -1.2; -1.3; -1.3; -0.9 | — |
| SECONDARY Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ... |
-1.2; -1.8; -1.1; -0.9; -1.1; -0.8 | — |
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.
Eligibility Criteria
Inclusion criteria
- decision to start treatment with intranasal fentanyl spray
- written informed consent
Exclusion criteria
- criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)
Data sourced from ClinicalTrials.gov (NCT00994760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.