Novel Non-opioid Post-surgical Pain Treatment in Females

NCT05087914 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: STU00215128
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine if treatment with Carbidopa/Levodopa and Naproxen in females (biological sex) with acute pain after a bunionectomy or toe fusion (24hrs, 48hrs and 5 days) will reduce pain when compared with females receiving Placebo and Naproxen.

Conditions

Acute Pain; Bunionectomy; Toe Fusion

Outcome Measures

Primary Outcomes (1)

• Post-Surgical Pain using Numeric Rating Scale (NRS)

  The primary endpoint will be the severity of pain measured by mean post surgical pain from surgery to end of intervention (\~1 week) and end of the study, as indexed by a NRS. The NRS pain scale is a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine''). Mean pain during treatment will be compared between intervention groups.

  1 and 4 weeks

Secondary Outcomes (2)

• Patient Global Impression of Change (PGIC)

  1 and 4 weeks

• Adverse Events

  1 and 4 weeks

Study Arms (2)

Carbidopa-Levodopa (100mg/25mg) + Naproxen (250mg)

EXPERIMENTAL

The study drug, Carbidopa-Levodopa, is an FDA-approved medicine traditionally used for the treatment of Parkinson's disease. The study drug will be used for an un-approved or un-labeled use: potentially managing pain in post-surgical patients. Carbidopa/Levodopa is an artificially made version of a naturally occurring hormone that helps regulate brain activity (Levodopa), combined with an artificially made version of a naturally occurring molecule that inhibits the breakdown of Levodopa (Carbidopa). Naproxen (250mg): Participants will receive one capsule TID, throughout the 5 days of the treatment period. Naproxen will be prescribed for active and control group.

Drug: Carbidopa-Levodopa (100mg/25mg):; Drug: Naproxen

Placebo + Naproxen (250mg)

PLACEBO COMPARATOR

Placebo:Participants will receive 1 the capsules on a three-times a day schedule for 5 days. A placebo looks like the study drug but is an inactive substance that has no medication. Researchers use a placebo to see if the study drug works better or is safer than not taking anything. Naproxen (250mg): Participants will receive one capsule TID, throughout the 5 days of the treatment period. Naproxen will be prescribed for active and control group.

Drug: Naproxen

Interventions

Carbidopa-Levodopa (100mg/25mg): DRUG

Participants will take 2 capsules (one containing naproxen, and the other containing either placebo or carbidopa/levodopa) 3 times per day (TID) for 5 days, the first dose is given right after the surgical procedure.

Also known as: Sinemet, Parcopa, Rytary

Carbidopa-Levodopa (100mg/25mg) + Naproxen (250mg)

Naproxen DRUG

Participants will take 2 capsules (one containing naproxen, and the other containing either placebo or carbidopa/levodopa) 3 times per day (TID) for 5 days, the first dose is given right after the surgical procedure.

Also known as: Aleve, Anaprox, Naprosyn, Naprelan, Menstridol

Carbidopa-Levodopa (100mg/25mg) + Naproxen (250mg); Placebo + Naproxen (250mg)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: female (biological sex) with no racial or ethnic restrictions
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female with no racial or ethnic restrictions;
• to 75 years old;
• Have a bunionectomy or toe fusion surgery scheduled;
• must be able to read, understand, and sign consent form;
• generally healthy.

You may not qualify if:

• Chronic neurologic conditions, e.g., Parkinson's
• pregnancy;
• opioids use 60 mg/day oral morphine milligram equivalent.;
• use of anticoagulants (low dose ASA allowed);
• history of gastric ulcer; renal insufficiency or congestive heart failure,
• contraindication to study medication as determined by surgeon
• Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk
• In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
• Diagnosis of psychological diseases, such as major depression; bipolar disorder.

Sponsors & Collaborators

• Northwestern University: lead
• Northwestern Medical Group: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

carbidopa, levodopa drug combination; Naproxen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: Director Center for Translational Pain Research; Director Center of Excellence for Chronic Pain and Drug Abuse Research; Professor of Neuroscience; Anesthesia, and PM&R

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 21, 2021
• Study Start: November 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: January 30, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)