What is the mechanism of action of this treatment?

The most common treatments for acute pain include nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen. NSAIDs, such as ibuprofen and naproxen, work by inhibiting cyclooxygenase (COX) enzymes, which play a key role in the production of prostaglandins that cause inflammation and pain. Acetaminophen, on the other hand, is believed to work centrally in the brain to reduce pain and fever, though its exact mechanism is not fully understood. These treatments are crucial for acute pain patients because they provide effective pain relief and reduce inflammation, allowing for improved comfort and faster recovery.

What side effects are associated with this type of intervention?

Common treatments for acute pain, such as nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen, can cause gastrointestinal issues (ulcers, bleeding, stomach pain), cardiovascular events (heart attack, stroke), kidney damage, and increased blood pressure. Opioid analgesics, another common option, may lead to drowsiness, constipation, nausea, addiction, and respiratory depression.

What prior FDA approvals exist?

The FDA has approved several analgesic and anti-inflammatory drugs for the treatment of acute pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen are commonly used due to their efficacy in reducing inflammation and pain. Celecoxib, a selective COX-2 inhibitor, is another NSAID with a favorable gastrointestinal risk profile. Additionally, combination drugs such as sumatriptan-naproxen have been approved for specific types of acute pain like migraines. These medications are similar in function to the investigational XG005 oral tablets being studied for pain control in bunionectomy patients.

What other types of research exist?

Promising novel alternatives to XG005 oral tablets for acute pain management include DFN-15 (Celecoxib Oral Solution), which has shown efficacy and safety in treating episodic migraine, and new indomethacin analogs that are selective COX-2 inhibitors with improved potency and reduced ulcerogenicity. Additionally, investigational approaches targeting nerve growth factor and other novel pain pathways are being explored for their potential in acute pain management.

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XG005 for Post-Bunionectomy Pain

Phase 2 & 3

Recruiting

Research Sponsored by Xgene Pharmaceutical Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled to undergo unilateral first metatarsal bunionectomy

Have negative urine drug screen

Must not have

Use of disallowed medications (e.g. pain medication, CNS active drugs such as benzodiazepines, tricyclic antidepressants, Serotonin, and norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), or any other serotonergic medications, parenteral or oral corticosteroids)

Digoxin, warfarin lithium, theophylline preparations, aminoglycosides, and all antiarrhythmics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 30

Summary

This trial will test the safety and effectiveness of XG005 pills in patients who have had bunion surgery. Patients will take either a low dose or high dose of the pill while staying in the clinic. The goal is to see if XG005 helps with recovery after surgery.

Who is the study for?

This trial is for non-pregnant, non-breastfeeding individuals who are scheduled for a bunionectomy and have no drug abuse history. They must not be on certain medications like painkillers or antidepressants, have stable blood pressure or diabetes treatments, and should not have severe depression or anxiety.

What is being tested?

The study tests the effectiveness of XG005 tablets in two doses (750 mg and 1250 mg) against a placebo for pain control after bunion surgery. Participants will stay at the clinic for three days post-surgery to ensure their safety and monitor results.

What are the potential side effects?

While specific side effects of XG005 aren't listed, common risks may include allergic reactions, potential interactions with other drugs if taken outside guidelines, and typical medication side effects such as nausea or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery to correct a bunion on my foot.

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My drug test results were negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any prohibited medications, including certain painkillers or antidepressants.

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I am not currently taking medications like digoxin, warfarin, or lithium.

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I am not taking any MAOI medications.

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I have hepatitis B surface antigen or core antibodies, but no surface antibodies.

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I have asthma, chronic rhinitis, or have had breathing issues with NSAIDs.

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I am allergic to naproxen, pregabalin, gabapentinoids, or any medication used during surgery.

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I have severe anxiety based on my GAD-7 score.

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I am HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Summed pain intensity from end of surgery to 48 hours post-surgery

Secondary study objectives

Continuous Pulse Oximetry

Cumulative Nausea (NNRS) assessment scores through 24 hours

Patient Global Assessment (PGA) at 48 hours

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: low doseExperimental Treatment2 Interventions

XG005 750 mg Q12 hours

Group II: high doseExperimental Treatment1 Intervention

XG005 1250 mg Q12 hours

Group III: placeboPlacebo Group1 Intervention

placebo Q12 hours

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo tablet

2020

Completed Phase 4

~6240

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for acute pain include nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen. NSAIDs, such as ibuprofen and naproxen, work by inhibiting cyclooxygenase (COX) enzymes, which play a key role in the production of prostaglandins that cause inflammation and pain. Acetaminophen, on the other hand, is believed to work centrally in the brain to reduce pain and fever, though its exact mechanism is not fully understood. These treatments are crucial for acute pain patients because they provide effective pain relief and reduce inflammation, allowing for improved comfort and faster recovery.

Nonsteroidal anti-inflammatory drugs and pain in cancer patients: a systematic review and reappraisal of the evidence.Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.