Trial Outcomes & Findings for Memantine and Postoperative Pain (NCT NCT01032759)

NCT ID: NCT01032759

Last Updated: 2016-03-14

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 77 participants
• Primary outcome timeframe: 24 hr
• Results posted on: 2016-03-14

Participant Flow

77 participants signed consent, 63 participants were randomized

Participant milestones

Measure	Memantine Memantine: 20 mg, BID	Placebo Placebo Placebo: BID
Overall Study STARTED	32	31
Overall Study Completed 24 Hour Assessment	32	30
Overall Study Completed 48 Hour Assessment	31	28
Overall Study COMPLETED	31	28
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Memantine and Postoperative Pain

Baseline characteristics by cohort

Measure	Memantine n=32 Participants Memantine: 20 mg, BID	Placebo n=31 Participants Placebo Placebo: BID	Total n=63 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 7 • n=5 Participants	59 years STANDARD_DEVIATION 7 • n=7 Participants	59 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	31 participants n=7 Participants	63 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hr

Population: Participants who completed the 24 hour assessment.

Outcome measures

Measure	Memantine n=32 Participants Memantine: 20 mg, BID	Placebo n=30 Participants Placebo Placebo: BID
24 hr Opioid Consumption	21.5 mg morphine equivalents Standard Deviation 3.9	18.6 mg morphine equivalents Standard Deviation 4.0

SECONDARY outcome

Timeframe: 48 hours

Population: Participants who completed the 48 hour assessment.

Pain score (0=no pain, 10= worst possible pain)

Outcome measures

Measure	Memantine n=31 Participants Memantine: 20 mg, BID	Placebo n=28 Participants Placebo Placebo: BID
Pain Scores	2.64 units on a scale Standard Deviation 0.46	1.71 units on a scale Standard Deviation 0.40

SECONDARY outcome

Timeframe: 0-24 h

Number of participants with postoperative nausea and vomiting.

Outcome measures

Measure	Memantine n=32 Participants Memantine: 20 mg, BID	Placebo n=30 Participants Placebo Placebo: BID
Opioid Related Side Effects	19 participants	19 participants

SECONDARY outcome

Timeframe: 0-24 h

Number of participants who experienced pruritus.

Outcome measures

Measure	Memantine n=32 Participants Memantine: 20 mg, BID	Placebo n=30 Participants Placebo Placebo: BID
Opioid Related Side Effects: Pruritus	7 participants	9 participants

SECONDARY outcome

Timeframe: Within 48 h

Population: Number of participants who had this outcome measured and documented

Stimulation with a Von Frey hair filament at 396 mN of force will be started from outside the hyperalgesic area, where no pain sensation is experienced toward the incision until the patient reports a distinct change in perception. The first point where a "painful," "sore," or "sharper" feeling occurs will be marked, and the distance to the incision measured. The surface area will be measured in cm2 around the surgical incision.

Outcome measures

Measure	Memantine n=20 Participants Memantine: 20 mg, BID	Placebo n=19 Participants Placebo Placebo: BID
Hyperalgesia	56 cm2 Standard Deviation 37	54 cm2 Standard Deviation 36

SECONDARY outcome

Timeframe: 48 hours

Population: Number of participants who had this outcome reported and documented.

Number of participants who reported "very satisfied" or "somewhat satisfied"

Outcome measures

Measure	Memantine n=32 Participants Memantine: 20 mg, BID	Placebo n=30 Participants Placebo Placebo: BID
Patient Satisfaction	30 participants	25 participants

SECONDARY outcome

Timeframe: 1 month, 3 month, 6 month

Population: Data was not collected and therefore not analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Memantine

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Memantine n=32 participants at risk Memantine: 20 mg, BID	Placebo n=31 participants at risk Placebo Placebo: BID
Nervous system disorders TIA	3.1% 1/32 • Number of events 1	0.00% 0/31
Cardiac disorders Pulmonary embolism	0.00% 0/32	3.2% 1/31 • Number of events 1

Other adverse events

Measure	Memantine n=32 participants at risk Memantine: 20 mg, BID	Placebo n=31 participants at risk Placebo Placebo: BID
Skin and subcutaneous tissue disorders Rash	0.00% 0/32	3.2% 1/31 • Number of events 1

Additional Information

Dr. Ashraf Habib

Duke University Medical Center

Phone: 9196686266

Email: habib001@dm.duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place