Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty

NCT04613024 | Withdrawn Early Phase 1

• 1 other identifier: 56915
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of topiramate (TPM) in obese patients with respect to weight loss and pain after total joint replacement surgery

Conditions

Weight Loss; Pain, Postoperative

Outcome Measures

Primary Outcomes (3)

• Determine the reduction in Opioid Consumption

  Postoperative morphine equivalent opiate use and opiate refill requests after discharge will be compared post randomization to receive one of the two medications for multimodal pain control.

  3 months

• Evaluate the Side Effect Profiles of Topiramate

  Perioperative weight change experienced by patients will be compared after randomization to receive one of the two medications. Weight change is measured in lbs

  3 months

• Evaluate the Side Effect Profiles of gabapentin

  Perioperative weight change experienced by patients will be compared after randomization to receive one of the two medications. Weight change is measured in lbs

  3 months

Secondary Outcomes (12)

• Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin

  1 week

• Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2 weeks

  2 week

• Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks

  6week

• Harris hip score -Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months

  3 months

• SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months

  3 months

Study Arms (2)

Experiment

EXPERIMENTAL

Topamax randomized group

Drug: Topamax

Control

ACTIVE COMPARATOR

Gabapentin randomized group

Drug: Gabapentin

Interventions

Topamax DRUG

Experiment randomized group will be prescribed Topamax before and after surgery with follow up at regular interval

Experiment

Gabapentin DRUG

Control group will be prescribed gabapentin after surgery with follow up at regular interval

Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient will be eligible for the study if they are scheduled for a primary TKA or THA with a BMI \>30 and \<40 kg/m2, or \>40 kg/m2
• Patients refusing bariatric surgery or having had prior bariatric surgery

You may not qualify if:

• Patients will be ineligible to participate if they have any of the following:
• known topiramate or gabapentin allergy
• history of seizure disorder
• chronic opiate use pre-operatively
• history of nephrolithiasis
• history of acute angle closure glaucoma
• recurrent major depression
• presence or history of suicidal behavior or ideation with intent to act
• current substantial depressive symptoms (Patient Health Questionnaire total score \>10), pregnancy
• child-bearing potential and not on contraception
• age \<18 years
• major neurocognitive disorder
• metabolic acidosis
• incarcerated status
• bilateral surgery

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, United States Minor Outlying Islands

Location

MeSH Terms

Conditions

Weight Loss; Pain, Postoperative

Interventions

Topiramate; Gabapentin

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; 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 Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistnat professor

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: November 3, 2020
• Study Start: July 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

UN (1)