Trial Outcomes & Findings for COMFORT: A Multicenter, Open-label, Randomized, Crossover Study (NCT NCT02462720)
NCT ID: NCT02462720
Last Updated: 2021-04-21
Results Overview
14-day average post-treatment pain using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
35 participants
Primary outcome timeframe
14 day average (0-100)
Results posted on
2021-04-21
Participant Flow
Participant milestones
| Measure |
Varithena® First Then Radiofrequency Ablation
Patients receive Varithena® treatment first in one leg, with 4-week follow-up period in Part 1; followed by Radiofrequency ablation in the other leg in Part 2.
Varithena® treatment administered in accordance with full prescribing information and instructions for use.
Radiofrequency ablation conducted per physicians' standard of care
|
Radiofrequency Ablation First Than Varithena
Patients will receive radiofrequency ablation treatment first in one leg, with 4-week follow-up period in Part 1; followed by Varithena® in the other leg in Part 2.
Varithena® treatment administered in accordance with full prescribing information and instructions for use.
Radiofrequency ablation conducted per physicians' standard of care
|
|---|---|---|
|
Part 1
STARTED
|
18
|
17
|
|
Part 1
COMPLETED
|
18
|
17
|
|
Part 1
NOT COMPLETED
|
0
|
0
|
|
Part 2
STARTED
|
18
|
17
|
|
Part 2
COMPLETED
|
17
|
16
|
|
Part 2
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Varithena® First Then Radiofrequency Ablation
Patients receive Varithena® treatment first in one leg, with 4-week follow-up period in Part 1; followed by Radiofrequency ablation in the other leg in Part 2.
Varithena® treatment administered in accordance with full prescribing information and instructions for use.
Radiofrequency ablation conducted per physicians' standard of care
|
Radiofrequency Ablation First Than Varithena
Patients will receive radiofrequency ablation treatment first in one leg, with 4-week follow-up period in Part 1; followed by Varithena® in the other leg in Part 2.
Varithena® treatment administered in accordance with full prescribing information and instructions for use.
Radiofrequency ablation conducted per physicians' standard of care
|
|---|---|---|
|
Part 2
Withdrawal by Subject
|
1
|
0
|
|
Part 2
Protocol Violation
|
0
|
1
|
Baseline Characteristics
COMFORT: A Multicenter, Open-label, Randomized, Crossover Study
Baseline characteristics by cohort
| Measure |
Varithena®
n=35 Participants
Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use followed by Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care.
Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care followed by Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use
|
|---|---|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 11.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 day average (0-100)14-day average post-treatment pain using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine.
Outcome measures
| Measure |
Varithena®
n=33 Participants
Varithena (polidocanol injectable foam) supplied as polidocanol solution 180 mg/18 mL (10 mg/mL) to be activated before use. Once activated, Varithena is a white injectable foam delivering a 1% polidocanol solution. Each milliliter of Varithena injectable foam contains 1.3 mg of polidocanol. Up to 5 mL per injection or 15 mL per treatment session could be used.
Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use
Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care.
|
Radiofrequency Ablation
n=33 Participants
RFA procedures were conducted in accordance with the physician's standard of care and according to the manufacturer's instructions for use.
Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use
Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care.
|
|---|---|---|
|
Pain
|
11.3 units on a scale
Standard Error 2.90
|
9.5 units on a scale
Standard Error 2.90
|
SECONDARY outcome
Timeframe: immediately following proceduredegree of procedural pain perceived by the patient obtained immediately following the procedure using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine
Outcome measures
| Measure |
Varithena®
n=33 Participants
Varithena (polidocanol injectable foam) supplied as polidocanol solution 180 mg/18 mL (10 mg/mL) to be activated before use. Once activated, Varithena is a white injectable foam delivering a 1% polidocanol solution. Each milliliter of Varithena injectable foam contains 1.3 mg of polidocanol. Up to 5 mL per injection or 15 mL per treatment session could be used.
Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use
Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care.
|
Radiofrequency Ablation
n=33 Participants
RFA procedures were conducted in accordance with the physician's standard of care and according to the manufacturer's instructions for use.
Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use
Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care.
|
|---|---|---|
|
Procedural Pain
|
16.4 units on a scale
Standard Error 3.53
|
17.8 units on a scale
Standard Error 3.53
|
SECONDARY outcome
Timeframe: 8 weeksPatient preference for RFA or Varithena® using e-diary
Outcome measures
| Measure |
Varithena®
n=33 Participants
Varithena (polidocanol injectable foam) supplied as polidocanol solution 180 mg/18 mL (10 mg/mL) to be activated before use. Once activated, Varithena is a white injectable foam delivering a 1% polidocanol solution. Each milliliter of Varithena injectable foam contains 1.3 mg of polidocanol. Up to 5 mL per injection or 15 mL per treatment session could be used.
Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use
Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care.
|
Radiofrequency Ablation
n=33 Participants
RFA procedures were conducted in accordance with the physician's standard of care and according to the manufacturer's instructions for use.
Varithena®: Varithena® treatment in accordance with full prescribing information and instructions for use
Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care.
|
|---|---|---|
|
Patient Preference
|
19 Participants
|
14 Participants
|
Adverse Events
Varithena®
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Radiofrequency Ablation
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Varithena®
n=34 participants at risk
Varithena® treatment in accordance with full prescribing information and instructions for use
Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care.
|
Radiofrequency Ablation
n=34 participants at risk
Varithena® treatment in accordance with full prescribing information and instructions for use
Radiofrequency ablation: Radiofrequency ablation conducted per physicians' standard of care.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/34 • Number of events 1 • A period of time ending at Week 4 (day 32)
|
5.9%
2/34 • Number of events 2 • A period of time ending at Week 4 (day 32)
|
|
Vascular disorders
Phlebitis
|
8.8%
3/34 • Number of events 3 • A period of time ending at Week 4 (day 32)
|
2.9%
1/34 • Number of events 1 • A period of time ending at Week 4 (day 32)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place