Bladder CarcinomaPhase 2/3NCT02355886
Gabapentin in Reducing the Need for Pain Medication in Patients With Bladder Cancer Undergoing Radical Cystectomy
A Phase 2/3 study testing Gabapentin and Questionnaire Administration in people with Bladder Carcinoma, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bladder Carcinoma
- What is being tested?
- Gabapentin and Questionnaire Administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2015to 28 Feb 2019
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of bladder cancer
- Anticipated radical cystectomy with ileal conduit or orthotopic neobladder
Who cannot join
- 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
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- Non-English speaking patients
- Chronic gabapentin, or the similar drug pregabalin, use
- Chronic narcotic use (daily or near daily use for > 90 days)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Randomized Placebo Control Trial of Perioperative Gabapentin to Reduce Total Analgesic Requirements in Patients Undergoing Radical Cystectomy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Bladder Carcinoma
- Being tested
- Gabapentin, Placebo, Questionnaire Administration
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Gralise, Neurontin
Given PO
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (gabapentin) | Experimental | Patients receive gabapentin PO TID for 48 hours after surgery. Receives: Drug: Gabapentin; Other: Questionnaire Administration |
| Arm II (placebo) | Placebo comparator | Patients receive placebo PO TID for 48 hours after surgery. Receives: Other: Placebo; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)
Geometric Mean and Standard Deviation of patient total equivalent analgesic
Measured: 48 hours post-radical cystectomy
Secondary outcomes (2)
Length of Stay Following Radical Cystectomy
The two study groups will be compared by Length of stay following radical cystectomy
Measured: duration of hospital stay. Days to weeks
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.
Measured: Up to 48 hours post-radical cystectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study start22 Apr 2015
- Primary completion28 Feb 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jonathan Wright, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355886
- Sponsor's protocol ID
- 9274
- Other IDs
- NCI-2015-00083, 9274, P30CA015704
- Status last verified
- May 2019
- First submitted
- 30 Jan 2015
- Last updated
- 4 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo Control Trial of Perioperative Gabapentin to Reduce Total Analgesic Requirements in Patients Undergoing Radical Cystectomy
- ClinicalTrials.gov ID
- NCT02355886
- Acronym / sponsor ID
- 9274
- Conditions
- Bladder Carcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Apr 2015 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Posted 4 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (gabapentin) | Experimental | Drug: Gabapentin, Other: Questionnaire AdministrationPatients receive gabapentin PO TID for 48 hours after surgery. |
| Arm II (placebo) | Placebo comparator | Other: Placebo, Other: Questionnaire AdministrationPatients receive placebo PO TID for 48 hours after surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of bladder cancer
- Anticipated radical cystectomy with ileal conduit or orthotopic neobladder
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinAlso: Gralise, NeurontinGiven PO | Drug | Arm I (gabapentin) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven PO | Other | Arm II (placebo) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (gabapentin), Arm II (placebo) |
Primary outcome
Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)
Time frame: 48 hours post-radical cystectomy
Geometric Mean and Standard Deviation of patient total equivalent analgesic
2 secondary outcomes
Length of Stay Following Radical Cystectomy
Time frame: duration of hospital stay. Days to weeks
Patient Self-assessed Pain on Numerical Pain Scale
Time frame: Up to 48 hours post-radical cystectomy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Wright principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gabapentin and Questionnaire Administration in people with Bladder Carcinoma, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Total Equivalent Analgesic Requirement (Morphine Equivalents) (time frame: 48 hours post-radical cystectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.