Trial Outcomes & Findings for The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain (NCT NCT01260454)

Results Overview

Patients will record the maximum intensity of pain (0-10) each day after placing an infusion site in a diary with which they are already comfortable. They will record the score each day for 14 days unless they have recorded "0" for two consecutive days. The primary outcome measure will be the average of those 14 maximum intensity pain scores (the sum of the maximum for each day divided by the number of days, generally 14; range 0-10).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

14 days after a new infusion site

Results posted on

2016-04-21

Participant Flow

26 participants who were previously recruited for a study called "SubQ works" were screened for this study.

Of the 26 screened 10 had a pain score \> or = 6 on two consecutive days. 6 of these 10 agreed to enroll.

Participant milestones

Participant milestones
Measure	Qutenza Patch We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin. Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Qutenza Patch n=6 Participants We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin. Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Region of Enrollment United States	6 participants n=99 Participants
mean pain level	4.15 Visual Analogue Scale STANDARD_DEVIATION 0.85 • n=99 Participants
mean worst pain level	7.99 Visual Analogue Scale STANDARD_DEVIATION 1.83 • n=99 Participants
Pain Relief Experienced with as needed Analgesics	1.66 units on a scale STANDARD_DEVIATION 0.86 • n=99 Participants

PRIMARY outcome

Timeframe: 14 days after a new infusion site

Population: One subject did not meet the inclusion criteria and was excluded from the efficacy analysis.

Patients will record the maximum intensity of pain (0-10) each day after placing an infusion site in a diary with which they are already comfortable. They will record the score each day for 14 days unless they have recorded "0" for two consecutive days. The primary outcome measure will be the average of those 14 maximum intensity pain scores (the sum of the maximum for each day divided by the number of days, generally 14; range 0-10).

Outcome measures

Outcome measures
Measure	Qutenza Patch n=5 Participants We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin. Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes
Pain Score on a Visual Analogue Scale	2.89 Visual Analogue Scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: 60 minute period of patch application and subsequent 3 days

Qutenza has not previously been used in patients with normal, healthy skin. We will assess the reaction to capsaicin in these patients as compared to the patients with unhealthy skin (post-herpetic neuralgia) who were studied in the registration trials for Qutenza. Pain immediately following Qutenza application was measured on a 10 point visual analog score with the word 'none' above 0 and 'agonizing' above 10.

Outcome measures

Outcome measures
Measure	Qutenza Patch n=6 Participants We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin. Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes
Number of Participants Who Experienced Greater Than 6 Pain Level Using the 10 Point Visual Analog Score	3 participants

SECONDARY outcome

Timeframe: 14 days

Population: One subject did not meet the inclusion criteria and was excluded from the efficacy analysis.

We counted the number of participants who used any amount of narcotic during the 14 day diary period.

Outcome measures

Outcome measures
Measure	Qutenza Patch n=5 Participants We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin. Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes
Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change	4 participants

Adverse Events

Qutenza Patch

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Qutenza Patch n=6 participants at risk We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin. Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes
General disorders pain at the application site	50.0% 3/6
Nervous system disorders headache	16.7% 1/6
Infections and infestations nasal congestion	16.7% 1/6
Infections and infestations sore throat	16.7% 1/6
Vascular disorders hypertension	16.7% 1/6

Additional Information

R. James White, MD, PhD

University of Rochester

Phone: 585-486-0869

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place