OsteoarthritisPhase 2NCT02342977
Effects of Lacosamide on Post-operative Opioid Requirements After a Total Hip Arthroplasty:
A Phase 2 study testing Lacosamide in people with Osteoarthritis and Rheumatoid Arthritis, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to determine how effect lacosamide is in reducing the amount of pain medication needed following a total hip arthroplasty. The study team hypothesizes that a single dose of lacosamide will reduce the amount of pain medication required after surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Avascular Necrosis
- What is being tested?
- Lacosamide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Aug 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be eligible for participation if they are 18-70 years of age.
- Patients who have an American Society of Anesthesiologists physical status I-III.
- Patients who are scheduled for primary total hip arthroplasty.
- Any patients who are willing to comply with study requirements and agrees to be in the study.
Who cannot join
- A patient's refusal to participate.
- Inability to give consent.
- Any patients on a scheduled opioid regimen for pain greater than 3 months.
- Bleeding diathesis.
- Hypersensitivity to lacosamide or any component of the formulation (some formulation contains phenylalanine) and/or any drug allergies to any medications used in this study.
- Second- or third-degree atrioventricular (AV) block, sick sinus syndrome without pacemaker, sodium channelopathies (e.g., Brugada syndrome), myocardial ischemia, heart failure, and structural heart disease.
Show all 14Show fewer
- Severe hepatic and or renal impairment.
- Pregnant or can become pregnant.
- Breast-Feeding.
- Have any suicidal thoughts, depression, or behavioral changes.
- Taking any antiepileptic medications.
- Any known seizure disorder (e.g. Lennox-Gastaut syndrome).
- Currently prescribed:
- Carbamazepine Strong inhibitors of cytochrome P450-2C9 (Capecitabine; Delavirdine; floxuridine; Fluorouracil (Systemic); Gemfibrozil; Nicardipine; Sitaxentan; Sulfadiazine; Sulfissoxazole; Tegafur; Tolbutamide) Strong inhibitors of cytochrome P450-3A4 (Atazanavir; Boceprevir; Chloramphenicol; Clarithromycin; Cobicistat; Conivaptan; Darunavir; Delavirdine; Fosamprenavir; Indinavir; Itraconazole; Ketoconazole (Systemic); Lopinavir; Nefazodone; Nelfinavir; Nicardipine; Posaconazole; Ritonavir; Saquinavir; Telaprevir; Telithromycin; Voriconazole) Delavirdine Fosphenytoin Nicardipin Phenobarbital Phenytoin Ethinylestradiol
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard L. Roudebush Veterans Affairs Medical Center
Indianapolis, Indiana, 46202
About this study
Official title: Effects of Lacosamide on Post-operative Opioid Requirements After a Total Hip Arthroplasty: A Randomized Double -Blinded, Placebo-controlled Pilot Study.
The purpose of this study is to determine how effect lacosamide is in reducing the amount of pain medication needed following a total hip arthroplasty. The study team hypothesizes that a single dose of lacosamide will reduce the amount of pain medication required after surgery. The study team plans to evaluate the amount of pain medication needed and quality of pain control during a subject's hospital stay and at their three month follow-up visit following their surgery.
Read the detailed description
All patients who agree to participate in this study will receive the same surgical and anesthetic techniques that are provided to all our patients undergoing this procedure at this institution. Post-operative treatment and therapy and follow-up will also be the same as any of our patients undergoing this procedure at this institution.
The only difference would be that patients would be randomized (determined by chance, like a flip of a coin) to either receive a single dose of lacosamide (100 mg by mouth) or placebo (sugar pill by mouth) before the surgical procedure. This would be the only experimental part of this study.
In addition, specific information will be collected throughout the patients care until discharged from the orthopedic clinic (approximately 3 months after the procedure). The collected information will include subject's age, race and ethnicity, sex, height, weight, American Society of Anesthesiologist physical status, total amount of opioid (pain medication) use, pain scores, nausea and vomiting, time spent in the post anesthesia care unit (time to discharge readiness), and discharge from the hospital. The patient's pain score and opioid use will be assessed during their follow-up at approximately 3 months (Note: all of the specific information collected is normally gathered or documented in our surgical patients' record). In addition, participants may withdraw from the study at any time.
The main goal of this study is to determine if lacosamide can reduce the amount of opioids required in patient's undergoing a total hip arthroplasty. Lacosamide is a FDA approved medication for the treatment of partial-onset seizures and is a man-made amino acid (usually are used as the building blocks from which proteins are made in the body) which block special proteins inby a change in the electricity that a cell may feel (voltage-gated sodium channel). Lacosamide is a new antiepileptic drug apparently lacking any major pharmacokinetic interactions (how the body affects a specific drug after administration, as well as the chemical changes of the substance in the body, and the effects and routes of excretion of the metabolites of the drug).
Lacosamide, carbamazepine and oxcarbazepine are known to block special proteins in the covering of cells which allow sodium into the cells when they are turned on by a change in the electricity that a cell may feel (voltage-gated sodium channel, NaV1.7). Lacosamide was chosen over carbamazepine and oxcarbazepine because it causes fewer side effects. Currently, lacosamide is being tested in patients with painful diabetic nerve pain. Further trials to identify lacosamide's potential in pain control and for other indications have been started.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Avascular Necrosis
- Being tested
- Placebo, Lacosamide
- Keywords
- total hip arthroplasty
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Patients will randomly receive placebo
LacosamideDrug
Patients will randomly receive lacosamide
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patient will randomly receive a placebo Receives: Drug: Placebo |
| Experimental | Experimental | Patients will randomly receive experimental drug (lacosamide). Receives: Drug: Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid use in Post anesthesia care unit
Post operative opioid use.
Measured: 30 minutes to 2 hours after surgery
Secondary outcomes (7)
Pain scores
Post operative pain scores
Measured: Post operative Day #0 through hospital discharge (4 day average)
Nausea and Vomiting
Post operative nausea and vomiting
Measured: Post operative Day #0 through hospital discharge (4 day average)
Total opioid use
Total post operative opioid use
Measured: Post operative Day #0 through hospital discharge (4 day average)
Time to PACU discharge readiness
Post operative discharge readiness
Measured: 30 minutes to 2 hours after surgery
Pain scores and opioid use at 3 month discharge
Development of chronic pain
Measured: At 3 month surgery follow up
Time to hospital discharge
Hospital discharge
Measured: Post operative Day #0 through hospital discharge ( 4 day average )
Possible side effects from Lacosamide
Possible side effects ( dizziness, headaches, visual changes, and nausea )
Measured: Post operative Day #0 through hospital discharge (4 day average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: We were unable to enroll any patients into the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development
- Responsible party
- Principal investigator, Bryan Sakamoto, VA Office of Research and Development
- Investigators
- Bryan M Sakamoto, M.D., PhD, Principal investigator, Richard L. Roudebush VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342977
- Sponsor's protocol ID
- 1408905316
- Status last verified
- Aug 2016
- First submitted
- 18 Dec 2014
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lacosamide on Post-operative Opioid Requirements After a Total Hip Arthroplasty: A Randomized Double -Blinded, Placebo-controlled Pilot Study.
- ClinicalTrials.gov ID
- NCT02342977
- Acronym / sponsor ID
- 1408905316
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Avascular Necrosis
- Keywords
- total hip arthroplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We were unable to enroll any patients into the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- VA Office of Research and Development
- Study start
- Nov 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 Jan 2015 (estimated)
- 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.
The purpose of this study is to determine how effect lacosamide is in reducing the amount of pain medication needed following a total hip arthroplasty. The study team hypothesizes that a single dose of lacosamide will reduce the amount of pain medication required after surgery. The study team plans to evaluate the amount of pain medication needed and quality of pain control during a subject's hospital stay and at their three month follow-up visit following their surgery.
Detailed description
All patients who agree to participate in this study will receive the same surgical and anesthetic techniques that are provided to all our patients undergoing this procedure at this institution. Post-operative treatment and therapy and follow-up will also be the same as any of our patients undergoing this procedure at this institution.
The only difference would be that patients would be randomized (determined by chance, like a flip of a coin) to either receive a single dose of lacosamide (100 mg by mouth) or placebo (sugar pill by mouth) before the surgical procedure. This would be the only experimental part of this study.
In addition, specific information will be collected throughout the patients care until discharged from the orthopedic clinic (approximately 3 months after the procedure). The collected information will include subject's age, race and ethnicity, sex, height, weight, American Society of Anesthesiologist physical status, total amount of opioid (pain medication) use, pain scores, nausea and vomiting, time spent in the post anesthesia care unit (time to discharge readiness), and discharge from the hospital. The patient's pain score and opioid use will be assessed during their follow-up at approximately 3 months (Note: all of the specific information collected is normally gathered or documented in our surgical patients' record). In addition, participants may withdraw from the study at any time.
The main goal of this study is to determine if lacosamide can reduce the amount of opioids required in patient's undergoing a total hip arthroplasty. Lacosamide is a FDA approved medication for the treatment of partial-onset seizures and is a man-made amino acid (usually are used as the building blocks from which proteins are made in the body) which block special proteins inby a change in the electricity that a cell may feel (voltage-gated sodium channel). Lacosamide is a new antiepileptic drug apparently lacking any major pharmacokinetic interactions (how the body affects a specific drug after administration, as well as the chemical changes of the substance in the body, and the effects and routes of excretion of the metabolites of the drug).
Lacosamide, carbamazepine and oxcarbazepine are known to block special proteins in the covering of cells which allow sodium into the cells when they are turned on by a change in the electricity that a cell may feel (voltage-gated sodium channel, NaV1.7). Lacosamide was chosen over carbamazepine and oxcarbazepine because it causes fewer side effects. Currently, lacosamide is being tested in patients with painful diabetic nerve pain. Further trials to identify lacosamide's potential in pain control and for other indications have been started.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPatient will randomly receive a placebo |
| Experimental | Experimental | Drug: LacosamidePatients will randomly receive experimental drug (lacosamide). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients will be eligible for participation if they are 18-70 years of age.
- Patients who have an American Society of Anesthesiologists physical status I-III.
- Patients who are scheduled for primary total hip arthroplasty.
- Any patients who are willing to comply with study requirements and agrees to be in the study.
Key exclusion criteria (14 listed)
- A patient's refusal to participate.
- Inability to give consent.
- Any patients on a scheduled opioid regimen for pain greater than 3 months.
- Bleeding diathesis.
- Hypersensitivity to lacosamide or any component of the formulation (some formulation contains phenylalanine) and/or any drug allergies to any medications used in this study.
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 |
|---|---|---|
| PlaceboPatients will randomly receive placebo | Drug | Placebo |
| LacosamidePatients will randomly receive lacosamide | Drug | Experimental |
Primary outcome
Opioid use in Post anesthesia care unit
Time frame: 30 minutes to 2 hours after surgery
Post operative opioid use.
7 secondary outcomes
Pain scores
Time frame: Post operative Day #0 through hospital discharge (4 day average)
Nausea and Vomiting
Time frame: Post operative Day #0 through hospital discharge (4 day average)
Total opioid use
Time frame: Post operative Day #0 through hospital discharge (4 day average)
Time to PACU discharge readiness
Time frame: 30 minutes to 2 hours after surgery
Pain scores and opioid use at 3 month discharge
Time frame: At 3 month surgery follow up
Time to hospital discharge
Time frame: Post operative Day #0 through hospital discharge ( 4 day average )
Possible side effects from Lacosamide
Time frame: Post operative Day #0 through hospital discharge (4 day average)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
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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.
Bryan M Sakamoto, M.D., PhD principal investigator
Richard L. Roudebush VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lacosamide in people with Osteoarthritis and Rheumatoid Arthritis, run by Indiana University at 1 site 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 4 inclusion and 14 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: withdrawn, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Opioid use in Post anesthesia care unit (time frame: 30 minutes to 2 hours after surgery). 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 26 Aug 2016.