Trial Outcomes & Findings for Effects of Pennsaid on Clinical Neuropathic Pain (NCT NCT01508676)

Last Updated: 2017-02-06

Results Overview

Subjects rated their pain using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion. The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study.

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

2 weeks.

Results posted on

2017-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	Pennsaid Phase I, Placebo Phase II Phase I: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily). Washout: 1 week, applying nothing. Phase II: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily).	Placebo Phase I, Pennsaid Phase II Phase I: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily). Washout: 1 week, applying nothing. Phase II: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily).
Phase I (2 Weeks) STARTED	18	17
Phase I (2 Weeks) COMPLETED	16	14
Phase I (2 Weeks) NOT COMPLETED	2	3
Washout Period (1 Week) STARTED	16	14
Washout Period (1 Week) COMPLETED	16	14
Washout Period (1 Week) NOT COMPLETED	0	0
Phase II (2 Weeks) STARTED	16	14
Phase II (2 Weeks) COMPLETED	15	13
Phase II (2 Weeks) NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pennsaid Phase I, Placebo Phase II Phase I: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily). Washout: 1 week, applying nothing. Phase II: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily).	Placebo Phase I, Pennsaid Phase II Phase I: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily). Washout: 1 week, applying nothing. Phase II: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily).
Phase I (2 Weeks) Medication Exclusion	1	1
Phase I (2 Weeks) Wrong Pain Type	1	0
Phase I (2 Weeks) Positive Drug Screen	0	2
Phase II (2 Weeks) Skin Sensitivity	0	1
Phase II (2 Weeks) Medication Exclusion	1	0

Baseline Characteristics

Effects of Pennsaid on Clinical Neuropathic Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pennsaid Phase I n=18 Participants Pennsaid (20-40 drops; 2-4 times daily). Upon completion of the first phase, subjects in each arm will be crossed over (i.e., from placebo to Pennsaid and vise versa). Pennsaid or placebo lotion will be packed in a container with identical appearance before being dispensed to study subjects.	Placebo Phase I n=17 Participants Placebo lotion (20-40 drops; 2-4 times daily). Upon completion of the first phase, subjects in each arm will be crossed over (i.e., from placebo to Pennsaid and vise versa). Pennsaid or placebo lotion will be packed in a container with identical appearance before being dispensed to study subjects.	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=93 Participants	15 Participants n=4 Participants	32 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Gender Female	9 Participants n=93 Participants	8 Participants n=4 Participants	17 Participants n=27 Participants
Gender Male	9 Participants n=93 Participants	9 Participants n=4 Participants	18 Participants n=27 Participants

PRIMARY outcome

Timeframe: 2 weeks.

Population: Only subjects who completed both phases of the crossover study were considered for data analysis.

Outcome measures

Outcome measures
Measure	Pennsaid n=28 Participants All subjects who recieved Pennsaid lotion in either Phase I or II were considered.	Placebo n=28 Participants All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
VAS After Treatment	4.9 Visual Analog Scale Standard Deviation 1.9	5.6 Visual Analog Scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 2 weeks

Population: Only subjects

Subjects rated their "burning pain" using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion. The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study.

Outcome measures

Outcome measures
Measure	Pennsaid n=28 Participants All subjects who recieved Pennsaid lotion in either Phase I or II were considered.	Placebo n=28 Participants All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
Clinical Neuropathic Pain Features- Burning After Treatment	2.9 Visual Analog Scale Standard Deviation 2.6	4.3 Visual Analog Scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 2 weeks

Subjects rated their "constant pain" and "hypersensitivity" using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion. The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study.

Outcome measures

Outcome measures
Measure	Pennsaid n=28 Participants All subjects who recieved Pennsaid lotion in either Phase I or II were considered.	Placebo n=28 Participants All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
Clinical Neuropathic Pain Features- Constant Pain and Hypersensitivity After Treatment	4.0 Visual Analog Scale Standard Deviation 2.9	4.3 Visual Analog Scale Standard Deviation 2.8

Adverse Events

Pennsaid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jianren Mao

Massachusetts General Hospital

Phone: 6177246102

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place