Trial Outcomes & Findings for Satisfaction in Patients Receiving the PegIntron Pen Plus Rebetol for Hepatitis C (Study P04244)(COMPLETED) (NCT NCT00705263)
NCT ID: NCT00705263
Last Updated: 2009-08-25
Results Overview
Participants were asked to evaluate the training they received in the proper use of the pen, the preparation and injection of the medicine, and to provide their subjective impressions about the use of the PegIntron pen. Satisfaction was defined as score 5 or above on a 7-point grading scale.
COMPLETED
113 participants
After 4 weeks of treatment.
2009-08-25
Participant Flow
113 patients were enrolled in the study; however, data were available for 110 subjects
Participant milestones
| Measure |
Patients With Chronic Hepatitis C
Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
|
|---|---|
|
Overall Study
STARTED
|
110
|
|
Overall Study
COMPLETED
|
108
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Patients With Chronic Hepatitis C
Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Satisfaction in Patients Receiving the PegIntron Pen Plus Rebetol for Hepatitis C (Study P04244)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Patients With Chronic Hepatitis C
n=110 Participants
Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
|
|---|---|
|
Age Continuous
|
40.25 years
STANDARD_DEVIATION 12.71 • n=93 Participants
|
|
Sex/Gender, Customized
Female
|
37 participants
n=93 Participants
|
|
Sex/Gender, Customized
Male
|
68 participants
n=93 Participants
|
|
Sex/Gender, Customized
Not provided
|
5 participants
n=93 Participants
|
|
Region of Enrollment
Slovenia
|
110 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: After 4 weeks of treatment.Population: Patients with chronic hepatitis C treated with PegIntron pen plus Rebetol
Participants were asked to evaluate the training they received in the proper use of the pen, the preparation and injection of the medicine, and to provide their subjective impressions about the use of the PegIntron pen. Satisfaction was defined as score 5 or above on a 7-point grading scale.
Outcome measures
| Measure |
Patients Treated With PegIntron Pen Plus Rebetol
n=110 Participants
|
|---|---|
|
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Helpfulness of the brochure: instructions
|
96 Satisfied Participants
|
|
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Injection technique: correctly injected
|
104 Satisfied Participants
|
|
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
No difficulties injecting
|
102 Satisfied Participants
|
|
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Overall impression
|
102 Satisfied Participants
|
|
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Satisfaction with the pen
|
102 Satisfied Participants
|
|
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Ease of setting the dose
|
101 Satisfied Participants
|
|
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Ease of use of the pen
|
101 Satisfied Participants
|
|
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Convenience of use of the pen
|
101 Satisfied Participants
|
|
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Easy injection
|
98 Satisfied Participants
|
|
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Correct dose
|
98 Satisfied Participants
|
|
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Overall helpfullness of the brochure
|
94 Satisfied Participants
|
|
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Helpfulness of the brochure: advice
|
91 Satisfied Participants
|
|
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Helpfulness of the brochure: general information
|
90 Satisfied Participants
|
|
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Difficulty of preparing the pen
|
90 Satisfied Participants
|
|
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Time required to prepare the pen
|
88 Satisfied Participants
|
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60