Trial Outcomes & Findings for Pain Expectations in Subjects With Osteoarthritis (NCT NCT02155257)

Last Updated: 2019-03-07

Results Overview

Resting pupil diameter will be measured using an infrared camera to obtain baseline measurements 2 hours after dosing subject pupil diameter measurements will be repeated

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

Baseline and 2 hours

Results posted on

2019-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	Modafinil Modafinil 200 mg will be administered orally one time Modafinil	Placebo A placebo will be administered orally one time Placebo	Gabapentin Gabapentin 900 mg will be administered orally one time Gabapentin
Overall Study STARTED	10	10	10
Overall Study COMPLETED	10	10	10
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pain Expectations in Subjects With Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Modafinil n=10 Participants Modafinil 200 mg will be administered orally one time Modafinil	Placebo n=10 Participants A placebo will be administered orally one time Placebo	Gabapentin n=10 Participants Gabapentin 900 mg will be administered orally one time Gabapentin	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	29 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 2 hours

Resting pupil diameter will be measured using an infrared camera to obtain baseline measurements 2 hours after dosing subject pupil diameter measurements will be repeated

Outcome measures

Outcome measures
Measure	Modafinil n=10 Participants Modafinil 200 mg will be administered orally one time Modafinil	Placebo n=10 Participants A placebo will be administered orally one time Placebo	Gabapentin n=10 Participants Gabapentin 900 mg will be administered orally one time Gabapentin
Resting Pupil Diameter 2 Hours	66.9 mm Standard Deviation 11.9	70.9 mm Standard Deviation 14.5	66.1 mm Standard Deviation 13.5
Resting Pupil Diameter Baseline	64 mm Standard Deviation 11.5	72 mm Standard Deviation 12.6	69 mm Standard Deviation 12.7

PRIMARY outcome

Timeframe: Reported 5 seconds after each stimulus

Pain is reported verbally after each stimulus by the subject on a scale of 0 (no pain) to 10 (worst imagineable pain). For each individual the value used is the average of all presentations of the 50 degree stimulus.

Outcome measures

Outcome measures
Measure	Modafinil n=10 Participants Modafinil 200 mg will be administered orally one time Modafinil	Placebo n=10 Participants A placebo will be administered orally one time Placebo	Gabapentin n=10 Participants Gabapentin 900 mg will be administered orally one time Gabapentin
Pain Intensity Rating	3.2 units on a scale Standard Deviation 1.7	2.8 units on a scale Standard Deviation 1.8	2.8 units on a scale Standard Deviation 2.0

PRIMARY outcome

Timeframe: baseline

Cognitive style determined for each individual by subtracting the score in the Pain Catastrophizing Scale (CATS) questionnaire (with a score range of 0-52 with higher score showing more catastrophizing) from the Life Orientation Test Revised (LOT-R) questionnaire (score range of 0-24, with a higher score denoting a better outcome). Thus, the total score could range from ranges from -52 to 24, with lower scores indicating worse cognitive style related to pain reporting and higher scores indicating better cognitive style related to pain reporting. There are no subscales here.

Outcome measures

Outcome measures
Measure	Modafinil n=10 Participants Modafinil 200 mg will be administered orally one time Modafinil	Placebo n=10 Participants A placebo will be administered orally one time Placebo	Gabapentin n=10 Participants Gabapentin 900 mg will be administered orally one time Gabapentin
Cognitive Style	18.2 score on a scale Standard Deviation 2.3	15.5 score on a scale Standard Deviation 2.3	14.8 score on a scale Standard Deviation 5.7

Adverse Events

Modafinil

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

Gabapentin

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. James Eisenach

Wake Forest University Health Sciences

Phone: 3367164182

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place