Hallux ValgusPhase 2NCT03838133
A Study to Evaluate Safety, PK, Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy
A Phase 2 study testing TLC590, Naropin® and Normal Saline in people with Hallux Valgus, run by Taiwan Liposome Company at 5 sites in United States.
Trial 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 subjects following bunionectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- TLC590, Naropin® and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Mar 2019to 31 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
JBR clinical research
Draper, Utah, 84020
Chesapeake Research Group
Pasadena, Maryland, 21122-1020
Arizona Research Center
Phoenix, Arizona, 85053
Endeavor Clinical Trials
San Antonio, Texas, 78229
About this study
Official title: A Phase 2, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy
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 subjects following bunionectomy.
Read the 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 subjects following bunionectomy.
The primary objective of this study is to evaluate the analgesic efficacy of TLC590 for post-surgical pain management in subjects following bunionectomy.
The secondary objectives of this study are:
- To evaluate the pharmacokinetic (PK) profile and dose-exposure relationship of TLC590, as well as the bioavailability as compared with Naropin®.
- To evaluate the safety and tolerability of TLC590 for post-surgical pain management in subjects following bunionectomy.
- To evaluate the exposure-response relationship between PK parameters and pain intensity.
The study will be divided into two parts:
Part 1: Blinded Pharmacokinetics of TLC590 and Naropin®. Approximately 48 subjects will be randomized to treatments.
Part 2: Efficacy and Safety of TLC590 versus bupivacaine and Placebo. Part 2 of the study will randomize approximately 150 evaluable subjects who meet all entry criteria.
- Conditions
- Hallux Valgus
- Being tested
- TLC590, Naropin®, Normal Saline, Bupivacaine
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC590Drug
Also called TLC590 (Ropivacaine Liposome Injectable Suspension)
TLC590, a sustained-release formulation of the local anesthetics with lipid-based excipients
Naropin®Drug
Also called Naropin, 0.5% Injectable Solution
Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. 50 mg (0.5%, 10 mL)
Normal SalineDrug
Also called Saline
Normal Saline (0.9% sodium chloride, 10ml)
BupivacaineDrug
Bupivacaine 50 mg (0.5%, 10 mL)
| Study group | Role | What they receive |
|---|---|---|
| TLC590 dose 1 (152 mg) | Experimental | TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL. Receives: Drug: TLC590 |
| TLC590 dose 2 (190 mg) | Experimental | TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL. Receives: Drug: TLC590 |
| TLC590 dose 3 (228 mg) | Experimental | TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL. Receives: Drug: TLC590 |
| Naropin® | Active comparator | Naronpin injection contains ropivacaine HCl 50 mg (0.5%, 10 mL) Receives: Drug: Naropin® |
| Placebo | Placebo comparator | Normal Saline (0.9% sodium chloride, 10 mL) Receives: Drug: Normal Saline |
| Bupivacaine | Active comparator | Bupivacaine HCl 50 mg (0.5%, 10 mL) Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of numerical pain rating scale
AUC of numerical pain rating scale (NPRS-R) following bunionectomy surgery
Measured: 0-24 hours, 0-72 hours
Secondary outcomes (12)
PK Cmax
Maximum blood concentration (Cmax)
Measured: 0-168 hours
PK Tmax
Time to reach maximum blood concentration (Tmax)
Measured: 0-168 hours
PK t½
Terminal elimination half-life (t½)
Measured: 0-168 hours
PK AUC
Area under the blood concentration-time curve (AUC)
Measured: 0-24, 0-48 , 0-72, 0-96 hours
Number of treatment emergent adverse event (TEAE)
Number of treatment emergent adverse event (TEAE) occurred in the study
Measured: Screening through Day 43
Electrocardiogram (RR interval, QRS duration, QT duration, PR duration, QTcF interval)
The 12-lead electrocardiogram (ECG) result will be assessed including RR interval, QRS duration, QT duration, PR duration, and QTcF interval
Measured: Screening through Day 43
Wound assessment by Numerical Pain Rating Scale (NPRS)
The surgical site will be examined by the investigator using a 5-point numerical pain rating scale as follows:
- Normal healing
- Bruising, erythema, edema
- Clear or hemoserous drainage
- Evidence of cellulitis such as heat, spreading erythema, purulent discharge
- Tissue breakdown, wound dehiscence, hematoma requiring aspiration
Measured: Day 1 through Day 43
AUC of NPRS-R (0-10)
AUC of NPRS-R (0-10)
Measured: 0-36, 0-48, 0-72, 0-96, 0-120,24-48, 48-72, 72-96, 96-120, and 120-168 hours
Proportion of pain-free (NPRS-R of 0 or 1) subjects
Proportion of pain-free (NPRS-R of 0 or 1) subjects
Measured: at 12, 24, 36, 48, 72, 96, 120, and 168 hours
Proportion of subjects who used no rescue opioid analgesic
Proportion of subjects who used no rescue opioid analgesic
Measured: through 12, 24, 36, 48, 72, 96, 120, and 168 hours
Time to the first postoperative use of rescue opioid analgesics
Time to the first postoperative use of rescue opioid analgesics
Measured: Day 1 to Day 43
Total postoperative consumption of rescue opioid analgesics used
Total postoperative consumption of rescue opioid analgesics used
Measured: through 24, 36, 48, 60, 72, 96, 120, and 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start5 Mar 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Liposome Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl Brown, PhD, Study director, Taiwan Liposome Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838133
- Sponsor's protocol ID
- TLC590A1002
- Status last verified
- Apr 2020
- First submitted
- 11 Feb 2019
- Last updated
- 7 Apr 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy
- ClinicalTrials.gov ID
- NCT03838133
- Acronym / sponsor ID
- TLC590A1002
- Conditions
- Hallux Valgus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Taiwan Liposome CompanyIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 subjects following bunionectomy.
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 subjects following bunionectomy.
The primary objective of this study is to evaluate the analgesic efficacy of TLC590 for post-surgical pain management in subjects following bunionectomy.
The secondary objectives of this study are:
- To evaluate the pharmacokinetic (PK) profile and dose-exposure relationship of TLC590, as well as the bioavailability as compared with Naropin®.
- To evaluate the safety and tolerability of TLC590 for post-surgical pain management in subjects following bunionectomy.
- To evaluate the exposure-response relationship between PK parameters and pain intensity.
The study will be divided into two parts:
Part 1: Blinded Pharmacokinetics of TLC590 and Naropin®. Approximately 48 subjects will be randomized to treatments.
Part 2: Efficacy and Safety of TLC590 versus bupivacaine and Placebo. Part 2 of the study will randomize approximately 150 evaluable subjects who meet all entry criteria.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| TLC590 dose 1 (152 mg) | Experimental | Drug: TLC590TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL. |
| TLC590 dose 2 (190 mg) | Experimental | Drug: TLC590TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL. |
| TLC590 dose 3 (228 mg) | Experimental | Drug: TLC590TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL. |
| Naropin® | Active comparator | Drug: Naropin®Naronpin injection contains ropivacaine HCl 50 mg (0.5%, 10 mL) |
| Placebo | Placebo comparator | Drug: Normal SalineNormal Saline (0.9% sodium chloride, 10 mL) |
| Bupivacaine | Active comparator | Drug: BupivacaineBupivacaine HCl 50 mg (0.5%, 10 mL) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLC590Also: TLC590 (Ropivacaine Liposome Injectable Suspension)TLC590, a sustained-release formulation of the local anesthetics with lipid-based excipients | Drug | TLC590 dose 1 (152 mg), TLC590 dose 2 (190 mg), TLC590 dose 3 (228 mg) |
| Naropin®Also: Naropin, 0.5% Injectable SolutionLocal infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. 50 mg (0.5%, 10 mL) | Drug | Naropin® |
| Normal SalineAlso: SalineNormal Saline (0.9% sodium chloride, 10ml) | Drug | Placebo |
| BupivacaineBupivacaine 50 mg (0.5%, 10 mL) | Drug | Bupivacaine |
Primary outcome
AUC of numerical pain rating scale
Time frame: 0-24 hours, 0-72 hours
AUC of numerical pain rating scale (NPRS-R) following bunionectomy surgery
12 secondary outcomes
PK Cmax
Time frame: 0-168 hours
PK Tmax
Time frame: 0-168 hours
PK t½
Time frame: 0-168 hours
PK AUC
Time frame: 0-24, 0-48 , 0-72, 0-96 hours
Number of treatment emergent adverse event (TEAE)
Time frame: Screening through Day 43
Electrocardiogram (RR interval, QRS duration, QT duration, PR duration, QTcF interval)
Time frame: Screening through Day 43
Wound assessment by Numerical Pain Rating Scale (NPRS)
Time frame: Day 1 through Day 43
AUC of NPRS-R (0-10)
Time frame: 0-36, 0-48, 0-72, 0-96, 0-120,24-48, 48-72, 72-96, 96-120, and 120-168 hours
Proportion of pain-free (NPRS-R of 0 or 1) subjects
Time frame: at 12, 24, 36, 48, 72, 96, 120, and 168 hours
Proportion of subjects who used no rescue opioid analgesic
Time frame: through 12, 24, 36, 48, 72, 96, 120, and 168 hours
Time to the first postoperative use of rescue opioid analgesics
Time frame: Day 1 to Day 43
Total postoperative consumption of rescue opioid analgesics used
Time frame: through 24, 36, 48, 60, 72, 96, 120, and 168 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Brown, PhD study director
Taiwan Liposome Company
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TLC590, Naropin® and Normal Saline in people with Hallux Valgus, run by Taiwan Liposome Company at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of numerical pain rating scale (time frame: 0-24 hours, 0-72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.