Gabapentin for the Reduction of Opiate Use Following Pulm... | NCT05100160

Studies
Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)

NCT05100160

Sponsor

M.D. Anderson Cancer Center

Status

Withdrawn

Last Update Posted

Apr 13, 2023Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Thoracic
Pulmonary Disease

Interventions

Gabapentin
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2021-10727	Other Identifier	NCI-CTRP Clinical Trials Reporting Registry

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

0 patient accrual

Expanded Access Info

Start Date

Sep 15, 2021Actual

Primary Completion Date

Jan 3, 2023Actual

Completion Date

Jan 3, 2023Actual

First Submitted Date

Sep 22, 2021

First Submission Date that Met QC Criteria

Oct 27, 2021

First Posted Date

Oct 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2023

Last Update Posted Date

Apr 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

Study Objectives:

The aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. We have defined clinically meaningful as a reduction by 25% Morphine equivalent doses (MED) Secondary objectives are to evaluate the utility of gabapentin in reducing postoperative pain, reducing hospital length of stay, promoting faster return to baseline function (to be assessed by MDASI), preventing post thoracotomy pain syndrome (to be assessed by BPI), and reducing the rate of chronic opiate use among patients undergoing thoracic procedures.

Primary Endpoint

The primary outcome will be the sum of the daily average morphine equivalent dose of opioids recorded from day of surgery (day 0) through 7 days after surgery, for a total of 8 days.
Secondary Endpoints
- Time to resuming normal activities
- Presence/absence of chronic pain at 3 and 6 months, measured by BPI
- 30, 90, 180 day opiate use (Y/N)
- MDASI on post-operative days 7, 30, 90, 180
- Basic Pain Inventory (BPI) on post-operative days 1,2, 7, 30, 90, 180
- Daily pain score during hospitalization
- Length of hospital stay
- Need for opioids at discharge
- Whether medication is stopped prior to day 25, and if so when and for what reason.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gabapentin	Experimental	used as part of a multimodal pain regimen (combination of drugs used to control pain	Drug: Gabapentin
Placebo	Experimental	designed to be compared with a study drug to learn if the study drug has any real effect	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gabapentin	Drug	Given by PO	Gabapentin
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo	The sum of the daily average morphine equivalent dose of opioids recorded from day of surgery (day 0) through 7 days after surgery, for a total of 8 days	through study completion, up to 8 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18+
Undergoing pulmonary resection (includes metastasectomy as well as anatomic resections)
Must have device with email capabilities for follow up survey

Exclusion Criteria:

Requiring narcotic pain medication or Gabapentin at the time of preoperative appointment or within 30 days of surgery
Renal impairment requiring dialysis
Allergy to Gabapentin

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Rice	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
M D Anderson Cancer Center		Houston	Texas	77030	United States

Label	URL
M D Anderson Cancer Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D008171	Lung Diseases

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077206	Gabapentin

Ancestor Terms

ID	Term
D000588	Amines
D009930	Organic Chemicals
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates

Browse Leaves

Not provided

Browse Branches

Not provided