NCT02355886

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

Completed Phase 2, PHASE3 Results posted Last updated 4 June 2019

What this trial tests

Phase 2, PHASE3 trial testing Gabapentin in Bladder Carcinoma in 25 participants. Completed in 28 February 2019.

Timeline

22 April 2015

Primary endpoint
28 February 2018

28 February 2019

Quick facts

Lead sponsor	University of Washington
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	25
Start date	22 April 2015
Primary completion	28 February 2018
Estimated completion	28 February 2019
Sites	1 location across United States

Drugs / interventions tested

• Gabapentin (Gabapentin) — full drug profile →
• Placebo
• Questionnaire Administration

Conditions studied

• Bladder Carcinoma — all drugs for Bladder Carcinoma →

Sponsor

University of Washington

Who can join

Adults 18 to 75, any sex, with Bladder Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Total Equivalent Analgesic Requirement (Morphine Equivalents) Primary · 48 hours post-radical cystectomy

Geometric Mean and Standard Deviation of patient total equivalent analgesic

Group	Value	95% CI
Arm I (Gabapentin)	297.65	± 179.95
Arm II (Placebo)	396.16	± 149.84

Length of Stay Following Radical Cystectomy Secondary · duration of hospital stay. Days to weeks

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

Group	Value	95% CI
Arm I (Gabapentin)	6.58	± 1.98
Arm II (Placebo)	6.73	± 2.83

Patient Self-assessed Pain on Numerical Pain Scale Secondary · 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.

Group	Value	95% CI
Arm I (Gabapentin)	5.15	± 2.8
Arm II (Placebo)	7.67	± 1.89

Adverse events — posted to ClinicalTrials.gov

Time frame: an average of one week. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm I (Gabapentin)

Serious: 0/13 (0%)

Deaths: 0/13

Arm II (Placebo)

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (2 terms — click to expand)

Reaction	System	Arm I (Gabapentin)	Arm II (Placebo)
nausea	Gastrointestinal disorders	—	—
sedation	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT02355886 adverse events section.

Sponsor's own description

This randomized phase II/III trial studies gabapentin in reducing the need for pain medication in patients with bladder cancer undergoing surgery to remove the bladder and nearby tissue and organs. Gabapentin may reduce the amount of pain medicine required after surgery, improve pain after surgery, and/or reduce the length of hospital stay after surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.