Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02922582
Other study ID # 404-C-201
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 28, 2016
Est. completion date November 27, 2017

Study information

Verified date December 2020
Source Pacira Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 2, randomized, single-blind, active-controlled dose-ranging study in subjects scheduled to undergo total knee arthroplasty (TKA).


Description:

Approximately 60 subjects (15 per arm) are planned for enrollment. Subjects will be randomized in a 1:1:1:1 ratio to receive either DepoTXA 400 mg, DepoTXA 800 mg, DepoTXA 1200 mg, or IV TXA (Cyklokapron® 1 gram).


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date November 27, 2017
Est. primary completion date November 27, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Male or female, =18 years of age at screening. 2. Scheduled to undergo elective unilateral open TKA under general, spinal, or regional anesthesia. 3. American Society of Anesthesiology (ASA) physical status 1, 2, or 3. 4. Female subject must be surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, or transdermal, contraceptive approved by the FDA for greater than 2 months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study. 5. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments. Exclusion Criteria: 1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. 2. Planned concurrent surgical procedure (e.g., bilateral TKA). 3. Prior open knee surgery on ipsilateral knee. Prior arthroscopy is permitted. 4. Subjects taking a medication with a known procoagulant effect (e.g., combination hormonal contraceptives, Factor IX complex concentrates or anti-inhibitor coagulant concentrates, or all-trans retinoic acid). 5. Contraindication or hypersensitivity to TXA. 6. History of thrombosis or prior Venous thromboembolism (VTE). 7. Known coagulopathy or active intravascular clotting. 8. Prior myocardial infarction. 9. Prior cardiovascular accident (stroke) or subarachnoid hemorrhage. 10. History of epilepsy. 11. Presence of an intravascular stent. 12. History of impaired kidney function, chronic respiratory disease, rheumatoid arthritis, coagulopathy, or loss of sensation in extremities. 13. Renal insufficiency (serum creatinine level >2 mg/dL). 14. Anemia (Hb level <10 g/dL). 15. Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments. 16. Acquired defective color vision. 17. 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. 18. Suspected or known history of drug or alcohol abuse within the previous year. 19. Body weight <50 kg (110 pounds) or a body mass index >44 kg/m2. 20. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
DepoTXA

Tranexamic Acid


Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina
United States Ohio State University/Wexner Medical Center Columbus Ohio
United States Ortho Arizona Gilbert Arizona
United States Kendall Regional Medical Center Miami Florida
United States University of Miami Hospital Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area Under the Plasma Concentration-versus-time Curve From Time 0 Extrapolated to Infinity After Drug Administration Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
Primary Area Under the Plasma Concentration-versus-time Curve From Time 0 to the Last Collection Time After Drug Administration Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
Primary Maximum Plasma Concentration (Cmax) Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
Primary Time to Maximum Plasma Concentration (Tmax) Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
Primary The Apparent Terminal Elimination Rate Constant Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
Primary The Apparent Terminal Elimination Half-life Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
Secondary Summary of Neurological Assessments (Proportion of Subjects Who Were Oriented and Proportion of Subjects Who Had Any of the Neurologic Events) at Each Assessed Timepoint Neurological assessment at 12, 24, 36, 48, 60, 72, and 96 hours after study drug administration 12, 24, 36, 48, 60, 72, and 96 hours after study drug administration
Secondary Incidence of Reoperation Due to Hematoma or Wound Dehiscence Number of subjects who underwent reoperation due to hematoma or wound dehiscence Through day 60
Secondary Incidence of Transfusion (Number of Units, Number of Units/Subject, Number of Subjects Transfused) Day 60
Secondary Number of Participants With 90° Passive and Active Knee Flexion 24, 48, and 72 hours
Secondary Time to Complete Timed Up-and-Go (TUG) Test Physical therapy assessment (Timed Up-and-Go (TUG) test) was conducted once postsurgically on Day 1; at approximately 8:00 am and 8:00 pm (±2 hours) daily from Day 2 through hospital discharge; and on Day 7 Day 1; at approximately 8:00 am and 8:00 pm (±2 hours) daily from Day 2 through hospital discharge; and on Day 7
Secondary Change in Knee and Thigh Measurements Leg difference in change from baseline is calculated by = (Operated Leg Change from Baseline) - (Non-Operated Leg Change from Baseline) 48 hours and Day 7
Secondary Area Under the Curve (AUC) of NRS From 0-24 Hours, 0-48 Hours, and 24-48 Hours Numerical rating scale (NRS) at rest pain score (0 [no pain] to 10 [worst possible pain]) upon arrival at the PACU; at each in-hospital vital sign assessment beginning with the 2-hour assessment and ending with the 48-hour assessment; and the Day-7 follow-up visit. Summary is provided as area under the curve (AUC) of NRS from timepoint 0 to 24 hours, 0 to 48 hours, and 24 to 48 hours. Preoperative; arrival in Post-Anesthesia Care Unit (PACU); 2, 4, 6, 8, 12, 16, 24, 36, 48 hours, Day 7
See also
  Status Clinical Trial Phase
Completed NCT03542981 - Interferential Current Therapy After Total Knee Arthroplasty N/A
Recruiting NCT04458480 - Effect of Fast Inpatient Rehabilitation After TKA
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Recruiting NCT06061367 - Muscles Strength and Gait Parameteres After TKA
Recruiting NCT05391828 - Persona MC vs PS RCT With ROSA N/A
Active, not recruiting NCT04850300 - Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses Phase 3
Completed NCT05635916 - Trial of Liposomal Bupivacaine for TKA Phase 4
Enrolling by invitation NCT05130216 - Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
Completed NCT03206554 - Local Infiltration Analgesia in Total Knee Arthroplasty Phase 2
Withdrawn NCT02495805 - Ultrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty N/A
Completed NCT01616836 - Optimizing Pain and Rehabilitation After Knee Arthroplasty Phase 3
Withdrawn NCT01511211 - Duration of Leg Nerve Blocks With Dexamethasone Added to Local Anesthetic Phase 4
Not yet recruiting NCT00958945 - Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements N/A
Completed NCT00985920 - Topical Tranexamic Acid for Total Knee Arthroplasty Phase 4
Completed NCT00761956 - A Study to Compare the NexGen CR and CR-Flex Knee Implants N/A
Completed NCT03289247 - Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty N/A
Terminated NCT03316118 - US Guided GNB vs Saline Injection for TKA Phase 4
Recruiting NCT05962970 - Continuous Adductor Canal Block in Fast Track Total Knee Arthroplasty N/A
Completed NCT03317834 - Navio With Total Knee Arthroplasty
Enrolling by invitation NCT06188091 - Joint Movement to Increase Range of Motion in Knee Joint After Primary Total Knee Arthroplasty N/A