Trial Outcomes & Findings for Gabapentin in Reducing the Need for Pain Medication in Patients With Bladder Cancer Undergoing Radical Cystectomy (NCT NCT02355886)

NCT ID: NCT02355886

Last Updated: 2019-06-04

Results Overview

Geometric Mean and Standard Deviation of patient total equivalent analgesic

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 25 participants
• Primary outcome timeframe: 48 hours post-radical cystectomy
• Results posted on: 2019-06-04

Participant Flow

Participant milestones

Measure	Arm I (Gabapentin) Patients receive gabapentin PO TID for 48 hours after surgery. Gabapentin: Given PO Questionnaire Administration: Ancillary studies	Arm II (Placebo) Patients receive placebo PO TID for 48 hours after surgery. Placebo: Given PO Questionnaire Administration: Ancillary studies
Overall Study STARTED	13	12
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gabapentin in Reducing the Need for Pain Medication in Patients With Bladder Cancer Undergoing Radical Cystectomy

Baseline characteristics by cohort

Measure	Arm I (Gabapentin) n=13 Participants Patients receive gabapentin PO TID for 48 hours after surgery. Gabapentin: Given PO Questionnaire Administration: Ancillary studies	Arm II (Placebo) n=12 Participants Patients receive placebo PO TID for 48 hours after surgery. Placebo: Given PO Questionnaire Administration: Ancillary studies	Total n=25 Participants Total of all reporting groups
Age, Continuous	66.82 years STANDARD_DEVIATION 9.69 • n=5 Participants	68.33 years STANDARD_DEVIATION 8.39 • n=7 Participants	67.5 years STANDARD_DEVIATION 9.31 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	00 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	12 participants n=7 Participants	25 participants n=5 Participants
neoadjuvant chemotherapy	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours post-radical cystectomy

Geometric Mean and Standard Deviation of patient total equivalent analgesic

Outcome measures

Measure	Arm I (Gabapentin) n=13 Participants Patients receive gabapentin PO TID for 48 hours after surgery. Gabapentin: Given PO Questionnaire Administration: Ancillary studies	Arm II (Placebo) n=12 Participants Patients receive placebo PO TID for 48 hours after surgery. Placebo: Given PO Questionnaire Administration: Ancillary studies
Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)	297.65 Total oral morphine equivalents in mg Standard Deviation 179.95	396.16 Total oral morphine equivalents in mg Standard Deviation 149.84

SECONDARY outcome

Timeframe: duration of hospital stay. Days to weeks

The two study groups will be compared by Length of stay following radical cystectomy

Outcome measures

Measure	Arm I (Gabapentin) n=13 Participants Patients receive gabapentin PO TID for 48 hours after surgery. Gabapentin: Given PO Questionnaire Administration: Ancillary studies	Arm II (Placebo) n=12 Participants Patients receive placebo PO TID for 48 hours after surgery. Placebo: Given PO Questionnaire Administration: Ancillary studies
Length of Stay Following Radical Cystectomy	6.58 days Standard Deviation 1.98	6.73 days Standard Deviation 2.83

SECONDARY outcome

Timeframe: Up to 48 hours post-radical cystectomy

The two study groups compared on Patient self-assessed pain on numerical pain likert scale. Numeric Pain Scale was utilized with values of 0-10 with increasing severity.

Outcome measures

Measure	Arm I (Gabapentin) n=13 Participants Patients receive gabapentin PO TID for 48 hours after surgery. Gabapentin: Given PO Questionnaire Administration: Ancillary studies	Arm II (Placebo) n=12 Participants Patients receive placebo PO TID for 48 hours after surgery. Placebo: Given PO Questionnaire Administration: Ancillary studies
Patient Self-assessed Pain on Numerical Pain Scale	5.15 Sore on a scale Standard Deviation 2.8	7.67 Sore on a scale Standard Deviation 1.89

Adverse Events

Arm I (Gabapentin)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm II (Placebo)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm I (Gabapentin) n=13 participants at risk Patients receive gabapentin PO TID for 48 hours after surgery. Gabapentin: Given PO Questionnaire Administration: Ancillary studies	Arm II (Placebo) n=12 participants at risk Patients receive placebo PO TID for 48 hours after surgery. Placebo: Given PO Questionnaire Administration: Ancillary studies
Gastrointestinal disorders nausea	23.1% 3/13 • Number of events 3 • an average of one week	83.3% 10/12 • Number of events 10 • an average of one week
Nervous system disorders sedation	38.5% 5/13 • Number of events 5 • an average of one week	8.3% 1/12 • Number of events 1 • an average of one week

Additional Information

George Schade

University of Washington

Phone: 2065986190

Email: grschade@uw.edu

Results disclosure agreements

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