Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00083 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 9274 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
PRIMARY OBJECTIVES:
I. To assess if perioperative gabapentin will decrease post-operative analgesic requirements within the first 48 hours after radical cystectomy (RC) in patients undergoing RC as measured morphine equivalents.
SECONDARY OBJECTIVES:
I. To assess patient self-assessment of postoperative pain on Numeric Pain Scale (NPS) at 24 and 48 hours.
II. To assess time to return of bowel function (ROBF).
III. To assess length of stay (LOS) following RC.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive gabapentin orally (PO) thrice daily (TID) for 48 hours after surgery.
ARM II: Patients receive placebo PO TID for 48 hours after surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (gabapentin) | Experimental | Patients receive gabapentin PO TID for 48 hours after surgery. |
|
| Arm II (placebo) | Placebo Comparator | Patients receive placebo PO TID for 48 hours after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Total Equivalent Analgesic Requirement (Morphine Equivalents) | Geometric Mean and Standard Deviation of patient total equivalent analgesic | 48 hours post-radical cystectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay Following Radical Cystectomy | The two study groups will be compared by Length of stay following radical cystectomy | duration of hospital stay. Days to weeks |
| Patient Self-assessed Pain on Numerical Pain Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Wright | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Gabapentin) | Patients receive gabapentin PO TID for 48 hours after surgery. Gabapentin: Given PO Questionnaire Administration: Ancillary studies |
| FG001 | Arm II (Placebo) | Patients receive placebo PO TID for 48 hours after surgery. Placebo: Given PO Questionnaire Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Gabapentin) | Patients receive gabapentin PO TID for 48 hours after surgery. Gabapentin: Given PO Questionnaire Administration: Ancillary studies |
| BG001 | Arm II (Placebo) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Total Equivalent Analgesic Requirement (Morphine Equivalents) | Geometric Mean and Standard Deviation of patient total equivalent analgesic | Posted | Geometric Mean | Standard Deviation | Total oral morphine equivalents in mg | 48 hours post-radical cystectomy |
|
an average of one week
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Gabapentin) | Patients receive gabapentin PO TID for 48 hours after surgery. Gabapentin: Given PO Questionnaire Administration: Ancillary studies |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Schade | University of Washington | 2065986190 | grschade@uw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2017 | Apr 2, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Given PO |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
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.
| Up to 48 hours post-radical cystectomy |
Patients receive placebo PO TID for 48 hours after surgery.
Placebo: Given PO
Questionnaire Administration: Ancillary studies
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| neoadjuvant chemotherapy | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Length of Stay Following Radical Cystectomy | The two study groups will be compared by Length of stay following radical cystectomy | Posted | Mean | Standard Deviation | days | duration of hospital stay. Days to weeks |
|
|
|
| Secondary | Patient Self-assessed Pain on Numerical Pain Scale | 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. | Posted | Mean | Standard Deviation | Sore on a scale | Up to 48 hours post-radical cystectomy |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 6 |
| 13 |
| EG001 | Arm II (Placebo) | Patients receive placebo PO TID for 48 hours after surgery. Placebo: Given PO Questionnaire Administration: Ancillary studies | 0 | 12 | 0 | 12 | 10 | 12 |
| sedation | Nervous system disorders | Non-systematic Assessment | PACU sedation |
|
Not provided
Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |