Status:
COMPLETED
A Study to Evaluate Safety, PK, Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy
Lead Sponsor:
Taiwan Liposome Company
Conditions:
Hallux Valgus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local administration in adult ...
Detailed Description
This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local administration in adult ...
Eligibility Criteria
Inclusion
- Able and willing to provide a written informed consent.
- Male or female between 18 and 65 years of age.
- Body mass index ≤ 35 kg/m2.
- Mild to moderate hallux valgus deformity.
- Scheduled to undergo a primary, unilateral first metatarsal bunionectomy repair under local anesthesia.
- American Society of Anesthesiology Physical Status Classification of 1 or 2 at screening.
- Female subjects are eligible only if all of the following apply:
- Not pregnant;
- Not lactating;
- Not planning to become pregnant during the study;
- Commits to the use of an acceptable form of birth control for the duration of the study and for 42 days from administration of study drug.
- Male subjects must be surgically sterile (biologically or surgically) or commit to the use of a reliable method of birth control, for the duration of the study until at least 1 week after the administration of study medication.
Exclusion
- Clinically significant abnormal clinical laboratory test value.
- Evidence of a clinically significant 12-lead ECG abnormality.
- History or evidence of orthostatic hypotension, syncope or other syncopal attacks.
- History or clinical manifestations of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
- A history of seizure disorder or currently taking anticonvulsants.
- History of hypersensitivity to ropivacaine, any other amide-type local anesthetic, propofol, lidocaine, midazolam, acetaminophen, naproxen, morphine or oxycodone (or other opioids).
- Concurrent painful physical condition that may confound post-operative pain assessments.
- Persistent or recurrent nausea and/or vomiting due to other etiologies.
- History of severe or refractory post-operative nausea or vomiting (PONV) deemed clinically significant.
- History of alcohol abuse or prescription/illicit drug abuse within 2 years.
- Current evidence of alcohol abuse within 6 months.
- Received opioid therapy for longer than 4 days per week within 2 months or opioid use within 2 weeks.
- Use of concurrent therapy that could interfere with the evaluation of efficacy or safety.
- Unable to discontinue medications that have not been at a stable dose for at least 14 days prior to the study surgical procedure, within 5 half-lives of the specific prior medication.
- Use of any of the following medications within 5 half-lives or as specified prior to the study surgical procedure:
- Low-dose aspirin therapy for cardiovascular protection
- Class III antiarrhythmic drugs
- Strong CYP1A2 inhibitors
- CYP1A2 substrates
- Strong CYP3A4 inhibitors
- Corticosteroids, either systemically, inhaled either intranasally or orally, or by intra-articular injection, or NSAIDs within 14 days
- Any investigational product within 30 days.
- Positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
- History or positive test results for HIV; active Hepatitis B or C.
- Contralateral foot bunionectomy in the last 3 months or have collateral procedures.
- Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
- History of rheumatoid disease, Type 1 or Type 2 diabetes or peripheral circulatory disorders.
- Documented sleep apnea or are on home continuous positive airway pressure.
Key Trial Info
Start Date :
March 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03838133
Start Date
March 5 2019
End Date
March 31 2020
Last Update
April 7 2020
Active Locations (5)
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1
Arizona Research Center
Phoenix, Arizona, United States, 85053
2
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
3
Chesapeake Research Group
Pasadena, Maryland, United States, 21122-1020
4
Endeavor Clinical Trials
San Antonio, Texas, United States, 78229