NCT02355886

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

April 22, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
3 months until next milestone

Results Posted

Study results publicly available

June 4, 2019

Completed
Last Updated

June 4, 2019

Status Verified

May 1, 2019

Enrollment Period

2.9 years

First QC Date

January 30, 2015

Results QC Date

February 25, 2019

Last Update Submit

May 13, 2019

Conditions

Bladder Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)

    Geometric Mean and Standard Deviation of patient total equivalent analgesic

    48 hours post-radical cystectomy

Secondary Outcomes (2)

  • Length of Stay Following Radical Cystectomy

    duration of hospital stay. Days to weeks

  • Patient Self-assessed Pain on Numerical Pain Scale

    Up to 48 hours post-radical cystectomy

Study Arms (2)

Arm I (gabapentin)

EXPERIMENTAL

Patients receive gabapentin PO TID for 48 hours after surgery.

Drug: GabapentinOther: Questionnaire Administration

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO TID for 48 hours after surgery.

Other: PlaceboOther: Questionnaire Administration

Interventions

GabapentinDRUG

Given PO

Also known as: Gralise, Neurontin
Arm I (gabapentin)
PlaceboOTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy
Arm II (placebo)
Questionnaire AdministrationOTHER

Ancillary studies

Arm I (gabapentin)Arm II (placebo)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of bladder cancer
  • Anticipated radical cystectomy with ileal conduit or orthotopic neobladder

You may not qualify if:

  • Presence of spinal cord injury including any form of paraplegia or quadriplegia
  • Allergy to gabapentin
  • Active alcohol dependence, defined as 2 or more positive questions on the CAGE alcoholism questionnaire
  • Illicit drug use (excluding recreational marijuana)
  • Chronic kidney disease with glomerular filtration rate \< 30 ml/min
  • Pregnancy: All female patients \< 55 years old (yo) will be administered a urine pregnancy test prior to enrollment
  • Non-English speaking patients
  • Chronic gabapentin, or the similar drug pregabalin, use
  • Chronic narcotic use (daily or near daily use for \> 90 days)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
George Schade
Organization
University of Washington
grschade@uw.edu
2065986190

Study Officials

  • Jonathan Wright

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 4, 2015

Study Start

April 22, 2015

Primary Completion

February 28, 2018

Study Completion

February 28, 2019

Last Updated

June 4, 2019

Results First Posted

June 4, 2019

Record last verified: 2019-05

Locations

US(1)