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

NCT05100160 | Withdrawn Phase 3 FDA Drug

• 2 other identifiers: 2021-0653NCI-2021-10727
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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 30 Morphine equivalent doses (MED)

Conditions

Thoracic; Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Gabapentin DRUG

Given by PO

Gabapentin

Placebo OTHER

Given by PO

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Lung Diseases

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• David Rice

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 29, 2021
• Study Start: September 15, 2021
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

US (1)