Trial Outcomes & Findings for Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C (Study P04067) (NCT NCT00727259)
NCT ID: NCT00727259
Last Updated: 2015-04-29
Results Overview
Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied).
COMPLETED
1995 participants
The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment.
2015-04-29
Participant Flow
Enrolled: 1995 subjects; all questionnaires were returned for 940 subjects.
Participant milestones
| Measure |
Patients With Chronic Hepatitis C
Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
|
|---|---|
|
Overall Study
STARTED
|
1995
|
|
Overall Study
COMPLETED
|
940
|
|
Overall Study
NOT COMPLETED
|
1055
|
Reasons for withdrawal
| Measure |
Patients With Chronic Hepatitis C
Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
|
|---|---|
|
Overall Study
Not all questionnaires completed
|
1055
|
Baseline Characteristics
Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C (Study P04067)
Baseline characteristics by cohort
| Measure |
Patients With Chronic Hepatitis C
n=940 Participants
Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol. Results presented concern only participants with all questionnaires returned (940).
|
|---|---|
|
Age, Continuous
|
47.50 years
STANDARD_DEVIATION 12.34 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
323 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
616 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing data
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
940 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment.Population: Both patient questionnaires were returned by 940 subjects. However, some items were not rated on the returned questionnaires. The missing data for questionnaire items range from 24 subjects to 72 subjects.
Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied).
Outcome measures
| Measure |
After 1 Month of Treatment
n=940 Participants
Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
|
After 3 Months of Treatment
n=940 Participants
Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
|
|---|---|---|
|
Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months
Time required for the preparation of the injection
|
5.49 satisfaction rating from 0-7
Standard Deviation 1.52
|
5.84 satisfaction rating from 0-7
Standard Deviation 1.32
|
|
Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months
Ease of preparation of the Pen
|
5.48 satisfaction rating from 0-7
Standard Deviation 1.74
|
5.91 satisfaction rating from 0-7
Standard Deviation 1.41
|
|
Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months
Simplicity of adjustment of the injected dose
|
5.74 satisfaction rating from 0-7
Standard Deviation 1.71
|
6.08 satisfaction rating from 0-7
Standard Deviation 1.41
|
|
Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months
Ease of injection
|
5.89 satisfaction rating from 0-7
Standard Deviation 1.46
|
6.00 satisfaction rating from 0-7
Standard Deviation 1.37
|
|
Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months
Characteristics of the needle
|
6.14 satisfaction rating from 0-7
Standard Deviation 1.25
|
6.25 satisfaction rating from 0-7
Standard Deviation 1.21
|
|
Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months
Overall satisfaction with the system of injection
|
5.99 satisfaction rating from 0-7
Standard Deviation 1.73
|
6.04 satisfaction rating from 0-7
Standard Deviation 1.32
|
Adverse Events
Patients With Chronic Hepatitis C
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication or communication (written or oral) could be performed by the Principal Investigator only after written approval from Schering-Plough.
- Publication restrictions are in place
Restriction type: OTHER