Arthroplasty, Replacement, KneePhase 2NCT00132392
ALGRX 4975 After Total Knee Replacement
A Phase 2 study testing ALGRX 4975 in people with Arthroplasty, Replacement, Knee and Knee Injuries, run by AlgoRx Pharmaceuticals at 1 site in United States.
Trial summary
ALGRX 4975 or placebo will be dripped onto the cut muscles and soft tissues before the end of surgery for total replacement of the knee. Each subject will undergo a screening visit; a hospitalization, during which total replacement of the knee will be performed; and follow-up visits at 2, 6, and 12 weeks after… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Knee Injuries
- What is being tested?
- ALGRX 4975
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Dec 2005
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject (male or female) is aged 35 - 80 years. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to administration of study drug; must be nonlactating; and must be willing to use adequate and reliable contraception throughout the study.
- The subject is planned to undergo unilateral TKA.
- The subject is willing and able to understand the study procedures and the use of pain scales, and to communicate meaningfully with the study personnel.
- The subject is in good health and capable of undergoing TKA.
- The subject has signed the Informed Consent approved by the Institutional Review Board (IRB).
Who cannot join
- The subject has a laboratory test value outside the accepted range unless approved by the Sponsor.
- The subject is currently taking or has taken a chronic opioid (more than 30 consecutive days of daily use) for pain other than knee pain in the past two years.
- The use of capsaicin, opioids, bupivacaine, ropivacaine, muscle relaxants, or acetaminophen is contraindicated in this subject (e.g., significant history of allergic reactions or intolerance to these or related substances).
- The use of general anesthesia is contraindicated in this subject.
- The subject is taking central nervous system (CNS) active drugs such as benzodiazepines, tricyclic antidepressants, or selective serotonin reuptake inhibitors (SSRIs) for pain. These drugs are permitted for non-pain indications if the dose has been stable for at least 30 days. The use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen is permitted if stable over at least 30 days. The use of lorazepam and other sleep medications is permitted. Administration of ketorolac tromethamine (Toradol®) is permitted preoperatively, intraoperatively, and postoperatively no later than 8 PM on the day of surgery.
- The subject has a medical condition that, in the Investigator's opinion, could adversely impact the subject's participation or safety; conduct of the study; or interfere with the pain assessments, including fracture or active infection.
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- The subject has diabetes mellitus and HbA1C > 9.5 or a history of prolonged uncontrolled diabetes.
- The subject has another painful physical condition that, in the opinion of the Investigator, may confound the assessments of postoperative pain or rehabilitation. The subject has a history of or current neuropathic pain condition.
- The subject is planned to undergo bilateral TKA.
- The subject has had arthroplasty (partial or total) of the index knee.
- The subject has a history of drug, prescription medicine or alcohol abuse within the past 2 years.
- The subject is taking an antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days
- The subject is taking any of the following medications: digoxin; all antiarrhythmics except beta-blockers; warfarin; theophylline preparations; aminoglycosides; anticonvulsants except benzodiazepines; and lithium.
- The subject has taken an investigational product within 3 months prior to the first dose of study drug (Visit 2), or is scheduled to receive an investigational product other than ALGRX 4975, while participating in the study.
- The subject has a known bleeding disorder or is taking agents affecting coagulation. Low dose aspirin is allowed as cardiac prophylaxis; NSAIDs, if stable for at least 30 days, are permitted; and deep venous thrombosis prophylaxis, of the surgeon's choice, is permitted postoperatively.
- The subject has previously participated in a clinical study with ALGRX 4975.
Trial locations and contacts
1 site in 1 country.
United States1 site
Capstone Clinical Trials, Inc.
Birmingham, Alabama, 35209
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of ALGRX 4975 in Subjects After Total Knee Arthroplasty
ALGRX 4975 or placebo will be dripped onto the cut muscles and soft tissues before the end of surgery for total replacement of the knee.
Each subject will undergo a screening visit; a hospitalization, during which total replacement of the knee will be performed; and follow-up visits at 2, 6, and 12 weeks after surgery. In addition, once discharged, subjects will be contacted by telephone daily up to Day 14. Subjects will complete pain and medication diaries during the first 2 weeks following surgery and will return these diaries at the 2 week visit.
Starting on the afternoon of Day 0 (the day of surgery), pain on active range of motion (ROM) of the operated knee will be measured each morning at 8 AM ± 2 hours and each afternoon at 3 PM ± 3 hours. In addition, if the subject ambulates, pain with ambulation will be measured during the first ambulation in the morning and during the first ambulation after noon. Subjects will complete the Brief Pain Inventory - Short Form (BPI-SF) preoperatively, and at the 2, 6, and 12 week visits. Subjects will be questioned regarding the use of assistive devices (cane, walker, wheelchair, bedside commode, or other assistive devices) at screening, at discharge, and at the 2, 6, and 12 week visits. The active ROM on flexion of the knee, measured using a goniometer, will be recorded at screening and at the 2 week visit. Sensory mapping of the knee will be performed at screening and at the 12 week visit.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, study conducted in subjects undergoing unilateral TKA. Subjects will undergo a screening visit up to 28 days prior to surgery. A sufficient number of subjects will be enrolled to obtain at least 40 evaluable subjects. Upon enrollment, subjects will be randomized in a 1:1 ratio of ALGRX 4975 to placebo. Subjects will receive a femoral nerve block prior to induction of general anesthesia. Subjects will undergo total knee arthroplasty (TKA) under general anesthesia. Prior to closure of the surgical wound, a single dose of ALGRX 4975 5 mg in 60 mL or placebo will be instilled (dripped by syringe over approximately 1 minute) into the wound onto the cut muscles and soft tissues and allowed to dwell for 5 minutes. The Investigator will then inject bupivacaine 0.25% up to 40 mL into the area of the wound and cut muscles and close the wound by usual surgical procedures. Postoperative pain will be managed by morphine sulfate administered intravenously by patient controlled analgesia (PCA). Following discontinuation of the PCA pump, subjects will be provided with hydrocodone 7.5 mg/acetaminophen 500 mg for postoperative pain.
Each subject will undergo a screening visit; a hospitalization, during which TKA will be performed; and follow-up visits at 2, 6, and 12 weeks after surgery. Subjects will receive twice daily examinations while hospitalized for the TKA procedure. In addition, once discharged, subjects will be contacted by telephone daily up to Day 14, to remind them to complete pain and medication diaries, and then again at 4 weeks after surgery for follow-up. Subjects will complete pain and medication diaries during the first 2 weeks following surgery and will return these diaries at the 2 week visit.
Starting on the afternoon of Day 0 (the day of surgery), pain on active range of motion (ROM) of the operated knee will be measured using an 11 point numerical rating scale (NRS) each morning at 8 AM ± 2 hours and each afternoon at 3 PM ± 3 hours, not within one hour after physical therapy. In addition, if the subject ambulates, pain with ambulation will be measured during the first ambulation in the morning and during the first ambulation after noon. Subjects will complete the Brief Pain Inventory - Short Form (BPI-SF) preoperatively, and at the 2, 6, and 12 week visits. Subjects will be questioned regarding the use of assistive devices (cane, walker, wheelchair, bedside commode, or other assistive devices) at screening, at discharge, and at the 2, 6, and 12 week visits. The active ROM on flexion of the knee, measured using a goniometer, will be recorded at screening and at the 2 week visit. Sensory mapping of the knee will be performed at screening and at the 12 week visit.
- Conditions
- Arthroplasty, Replacement, Knee, Knee Injuries
- Being tested
- ALGRX 4975
- Keywords
- Arthroplasty, Total knee arthroplasty, Capsaicin, Pain, Analgesia
- Medical subject headings
- Knee Injuries, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALGRX 4975Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The daily average of the numerical rating scale (NRS) for pain with active range of motion of the operated knee at 8 AM ± 2 hours and at 3 PM ± 3 hours on Day 1, on Day 2, and on Days 1 through 2
Secondary outcomes (9)
The daily average of the numerical rating for pain with active range of motion of the operated knee at 8 AM ± 2 hours and at 3 PM ± 3 hours on Days 3 through 14, and Days 1 through 14
The daily average of the numerical rating for pain during first ambulation in the morning and first ambulation after noon on Day 1, Day 2, Days 1 through 14, and Days 3 through 14
Morphine sulfate that the subject self-administers for postoperative pain for each 12 hour period postoperatively starting at 8 AM on the day following surgery
Time to first dose of supplemental pain medication (hydrocodone 7.5 mg/acetaminophen 500 mg) after self-administration of morphine sulfate is discontinued
Number of tablets of hydrocodone 7.5 mg/acetaminophen 500 mg used during the first two postoperative weeks after total knee arthroplasty (TKA)
The average quantity of hydrocodone 7.5 mg/acetaminophen 500 mg used during the first two postoperative weeks after surgery
Pain and pain interference with activities at 2, 6, and 12 weeks using the Brief Pain Inventory-Short Form (BPI-SF)
Effect of ALGRX 4975 on the use of assistive devices (cane, walker, wheelchair, bedside commode, or other assistive devices) at discharge, 2, 6, and 12 weeks
Effect of ALGRX 4975 on active flexion range of motion of the operated knee, measured using a goniometer, at the 2 week postoperative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startJul 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- AlgoRx Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132392
- Sponsor's protocol ID
- 4975-2-010-1
- Status last verified
- Aug 2005
- First submitted
- 18 Aug 2005
- Last updated
- 20 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of ALGRX 4975 in Subjects After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00132392
- Acronym / sponsor ID
- 4975-2-010-1
- Conditions
- Arthroplasty, Replacement, Knee, Knee Injuries
- Keywords
- Arthroplasty, Total knee arthroplasty, Capsaicin, Pain, Analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- AlgoRx PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Dec 2005
- First posted
- 22 Aug 2005 (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.
ALGRX 4975 or placebo will be dripped onto the cut muscles and soft tissues before the end of surgery for total replacement of the knee.
Each subject will undergo a screening visit; a hospitalization, during which total replacement of the knee will be performed; and follow-up visits at 2, 6, and 12 weeks after surgery. In addition, once discharged, subjects will be contacted by telephone daily up to Day 14. Subjects will complete pain and medication diaries during the first 2 weeks following surgery and will return these diaries at the 2 week visit.
Starting on the afternoon of Day 0 (the day of surgery), pain on active range of motion (ROM) of the operated knee will be measured each morning at 8 AM ± 2 hours and each afternoon at 3 PM ± 3 hours. In addition, if the subject ambulates, pain with ambulation will be measured during the first ambulation in the morning and during the first ambulation after noon. Subjects will complete the Brief Pain Inventory - Short Form (BPI-SF) preoperatively, and at the 2, 6, and 12 week visits. Subjects will be questioned regarding the use of assistive devices (cane, walker, wheelchair, bedside commode, or other assistive devices) at screening, at discharge, and at the 2, 6, and 12 week visits. The active ROM on flexion of the knee, measured using a goniometer, will be recorded at screening and at the 2 week visit. Sensory mapping of the knee will be performed at screening and at the 12 week visit.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, study conducted in subjects undergoing unilateral TKA. Subjects will undergo a screening visit up to 28 days prior to surgery. A sufficient number of subjects will be enrolled to obtain at least 40 evaluable subjects. Upon enrollment, subjects will be randomized in a 1:1 ratio of ALGRX 4975 to placebo. Subjects will receive a femoral nerve block prior to induction of general anesthesia. Subjects will undergo total knee arthroplasty (TKA) under general anesthesia. Prior to closure of the surgical wound, a single dose of ALGRX 4975 5 mg in 60 mL or placebo will be instilled (dripped by syringe over approximately 1 minute) into the wound onto the cut muscles and soft tissues and allowed to dwell for 5 minutes. The Investigator will then inject bupivacaine 0.25% up to 40 mL into the area of the wound and cut muscles and close the wound by usual surgical procedures. Postoperative pain will be managed by morphine sulfate administered intravenously by patient controlled analgesia (PCA). Following discontinuation of the PCA pump, subjects will be provided with hydrocodone 7.5 mg/acetaminophen 500 mg for postoperative pain.
Each subject will undergo a screening visit; a hospitalization, during which TKA will be performed; and follow-up visits at 2, 6, and 12 weeks after surgery. Subjects will receive twice daily examinations while hospitalized for the TKA procedure. In addition, once discharged, subjects will be contacted by telephone daily up to Day 14, to remind them to complete pain and medication diaries, and then again at 4 weeks after surgery for follow-up. Subjects will complete pain and medication diaries during the first 2 weeks following surgery and will return these diaries at the 2 week visit.
Starting on the afternoon of Day 0 (the day of surgery), pain on active range of motion (ROM) of the operated knee will be measured using an 11 point numerical rating scale (NRS) each morning at 8 AM ± 2 hours and each afternoon at 3 PM ± 3 hours, not within one hour after physical therapy. In addition, if the subject ambulates, pain with ambulation will be measured during the first ambulation in the morning and during the first ambulation after noon. Subjects will complete the Brief Pain Inventory - Short Form (BPI-SF) preoperatively, and at the 2, 6, and 12 week visits. Subjects will be questioned regarding the use of assistive devices (cane, walker, wheelchair, bedside commode, or other assistive devices) at screening, at discharge, and at the 2, 6, and 12 week visits. The active ROM on flexion of the knee, measured using a goniometer, will be recorded at screening and at the 2 week visit. Sensory mapping of the knee will be performed at screening and at the 12 week visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject (male or female) is aged 35 - 80 years. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to administration of study drug; must be nonlactating; and must be willing to use adequate and reliable contraception throughout the study.
- The subject is planned to undergo unilateral TKA.
- The subject is willing and able to understand the study procedures and the use of pain scales, and to communicate meaningfully with the study personnel.
- The subject is in good health and capable of undergoing TKA.
- The subject has signed the Informed Consent approved by the Institutional Review Board (IRB).
Key exclusion criteria (16 listed)
- The subject has a laboratory test value outside the accepted range unless approved by the Sponsor.
- The subject is currently taking or has taken a chronic opioid (more than 30 consecutive days of daily use) for pain other than knee pain in the past two years.
- The use of capsaicin, opioids, bupivacaine, ropivacaine, muscle relaxants, or acetaminophen is contraindicated in this subject (e.g., significant history of allergic reactions or intolerance to these or related substances).
- The use of general anesthesia is contraindicated in this subject.
- The subject is taking central nervous system (CNS) active drugs such as benzodiazepines, tricyclic antidepressants, or selective serotonin reuptake inhibitors (SSRIs) for pain. These drugs are permitted for non-pain indications if the dose has been stable for at least 30 days. The use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen is permitted if stable over at least 30 days. The use of lorazepam and other sleep medications is permitted. Administration of ketorolac tromethamine (Toradol®) is permitted preoperatively, intraoperatively, and postoperatively no later than 8 PM on the day of surgery.
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 |
|---|---|---|
| ALGRX 4975 | Drug | – |
Primary outcome
The daily average of the numerical rating scale (NRS) for pain with active range of motion of the operated knee at 8 AM ± 2 hours and at 3 PM ± 3 hours on Day 1, on Day 2, and on Days 1 through 2
9 secondary outcomes
The daily average of the numerical rating for pain with active range of motion of the operated knee at 8 AM ± 2 hours and at 3 PM ± 3 hours on Days 3 through 14, and Days 1 through 14
The daily average of the numerical rating for pain during first ambulation in the morning and first ambulation after noon on Day 1, Day 2, Days 1 through 14, and Days 3 through 14
Morphine sulfate that the subject self-administers for postoperative pain for each 12 hour period postoperatively starting at 8 AM on the day following surgery
Time to first dose of supplemental pain medication (hydrocodone 7.5 mg/acetaminophen 500 mg) after self-administration of morphine sulfate is discontinued
Number of tablets of hydrocodone 7.5 mg/acetaminophen 500 mg used during the first two postoperative weeks after total knee arthroplasty (TKA)
The average quantity of hydrocodone 7.5 mg/acetaminophen 500 mg used during the first two postoperative weeks after surgery
Pain and pain interference with activities at 2, 6, and 12 weeks using the Brief Pain Inventory-Short Form (BPI-SF)
Effect of ALGRX 4975 on the use of assistive devices (cane, walker, wheelchair, bedside commode, or other assistive devices) at discharge, 2, 6, and 12 weeks
Effect of ALGRX 4975 on active flexion range of motion of the operated knee, measured using a goniometer, at the 2 week postoperative visit
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 20 Dec 2006.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ALGRX 4975 in people with Arthroplasty, Replacement, Knee and Knee Injuries, run by AlgoRx Pharmaceuticals 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 5 inclusion and 16 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 20 Dec 2006. 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. 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?
The daily average of the numerical rating scale (NRS) for pain with active range of motion of the operated knee at 8 AM ± 2 hours and at 3 PM ± 3 hours on Day 1, on Day 2, and on Days 1 through 2. 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 20 Dec 2006.