NCT02922582 is a Phase 2 clinical trial of DepoTXA in Total Knee Arthroplasty, sponsored by Pacira Pharmaceuticals, Inc.

Who is sponsoring NCT02922582?

NCT02922582 is sponsored by Pacira Pharmaceuticals, Inc.

What drugs are being tested in NCT02922582?

Interventions in NCT02922582: DepoTXA, Tranexamic Acid.

What condition does NCT02922582 study?

NCT02922582 studies Total Knee Arthroplasty.

Is NCT02922582 still recruiting?

NCT02922582 is currently terminated. Last updated 11 December 2020.

Are results published for NCT02922582?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-12-11 · How we verify

NCT02922582

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Local Administration of DepoTXA for Reduced Postsurgical Bleeding in Subjects Undergoing TKA

Terminated Phase 2 Results posted Last updated 11 December 2020

What this trial tests

Phase 2 trial testing DepoTXA in Total Knee Arthroplasty in 16 participants. Terminated before completion.

Timeline

28 October 2016

Primary endpoint
27 November 2017

27 November 2017

Quick facts

Lead sponsor	Pacira Pharmaceuticals, Inc
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	16
Start date	28 October 2016
Primary completion	27 November 2017
Estimated completion	27 November 2017
Sites	5 locations across United States

Drugs / interventions tested

DepoTXA — full drug profile →
Tranexamic Acid (Tranexamic Acid) — full drug profile →

Conditions studied

Total Knee Arthroplasty — all drugs for Total Knee Arthroplasty →

Sponsor

Pacira Pharmaceuticals, Inc — full company profile →

Who can join

18 and older, any sex, with Total Knee Arthroplasty. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area Under the Plasma Concentration-versus-time Curve From Time 0 Extrapolated to Infinity After Drug Administration Primary · 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.

Group	Value	95% CI
DepoTXA 400mg	46462.15	± 6935.828
DepoTXA 800mg	106422.7	± 42128.84
DepoTXA 1200mg	148806.2	± 14137.74
IV Tranexamic Acid (TXA)	134602.2	± 29975.88

Area Under the Plasma Concentration-versus-time Curve From Time 0 to the Last Collection Time After Drug Administration Primary · 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.

Group	Value	95% CI
DepoTXA 400mg	43784.71	± 6463.220
DepoTXA 800mg	104546.5	± 42813.20
DepoTXA 1200mg	143562.9	± 13931.94
IV Tranexamic Acid (TXA)	131153.0	± 27286.97

Maximum Plasma Concentration (Cmax) Primary · 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.

Group	Value	95% CI
DepoTXA 400mg	2775.0	± 741.96
DepoTXA 800mg	7722.0	± 2015.25
DepoTXA 1200mg	9827.0	± 1545.83
IV Tranexamic Acid (TXA)	125390.0	± 154587.6

Time to Maximum Plasma Concentration (Tmax) Primary · 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.

Group	Value	95% CI
DepoTXA 400mg	1.6	± 0.55
DepoTXA 800mg	1.5	± 0.57
DepoTXA 1200mg	2.5	± 0.96
IV Tranexamic Acid (TXA)	0.1	± 0

The Apparent Terminal Elimination Rate Constant Primary · 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.

Group	Value	95% CI
DepoTXA 400mg	0.048	± 0.0084
DepoTXA 800mg	0.035	± 0.0120
DepoTXA 1200mg	0.035	± 0.0095
IV Tranexamic Acid (TXA)	0.136	± 0.0261

The Apparent Terminal Elimination Half-life Primary · 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.

Group	Value	95% CI
DepoTXA 400mg	14.679	± 2.6980
DepoTXA 800mg	21.132	± 7.2508
DepoTXA 1200mg	20.956	± 5.7276
IV Tranexamic Acid (TXA)	5.220	± 0.8540

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 Secondary · 12, 24, 36, 48, 60, 72, and 96 hours after study drug administration

Neurological assessment at 12, 24, 36, 48, 60, 72, and 96 hours after study drug administration

Number of subjects who had any of the neurologic events at baseline

Group	Value	95% CI
DepoTXA 400mg	0
DepoTXA 800mg	0
DepoTXA 1200mg	0
IV Tranexamic Acid (TXA)	0

Number of subjects who had any of the neurologic events at 12 hours

Group	Value	95% CI
DepoTXA 400mg	0
DepoTXA 800mg	0
DepoTXA 1200mg	0
IV Tranexamic Acid (TXA)	0

Number of subjects who had any of the neurologic events at 24 hours

Group	Value	95% CI
DepoTXA 400mg	0
DepoTXA 800mg	0
DepoTXA 1200mg	0
IV Tranexamic Acid (TXA)	0

Number of subjects who had any of the neurologic events at 36 hours

Group	Value	95% CI
DepoTXA 400mg	0
DepoTXA 800mg	0
DepoTXA 1200mg	0
IV Tranexamic Acid (TXA)	0

Number of subjects who had any of the neurologic events at 48 hours

Group	Value	95% CI
DepoTXA 400mg	0
DepoTXA 800mg	0
DepoTXA 1200mg	0
IV Tranexamic Acid (TXA)	0

Number of subjects who had any of the neurologic events at 60 hours

Group	Value	95% CI
DepoTXA 400mg	0
DepoTXA 800mg	0
DepoTXA 1200mg	0
IV Tranexamic Acid (TXA)	0

Number of subjects who had any of the neurologic events at 72 hours

Group	Value	95% CI
DepoTXA 400mg	0
DepoTXA 800mg	0
DepoTXA 1200mg	0
IV Tranexamic Acid (TXA)	0

Number of subjects who had any of the neurologic events at 96 hours

Group	Value	95% CI
DepoTXA 400mg	0
DepoTXA 800mg	0
DepoTXA 1200mg	0
IV Tranexamic Acid (TXA)	0

Incidence of Reoperation Due to Hematoma or Wound Dehiscence Secondary · Through day 60

Number of subjects who underwent reoperation due to hematoma or wound dehiscence

Group	Value	95% CI
DepoTXA 400mg	0
DepoTXA 800mg	0
DepoTXA 1200mg	0
IV Tranexamic Acid (TXA)	0

Incidence of Transfusion (Number of Units, Number of Units/Subject, Number of Subjects Transfused) Secondary · Day 60

Group	Value	95% CI
DepoTXA 400mg	0
DepoTXA 800mg	0
DepoTXA 1200mg	0
IV Tranexamic Acid (TXA)	0

Number of Participants With 90˚ Passive and Active Knee Flexion Secondary · 24, 48, and 72 hours

Number of subjects who had 90˚ active knee flexion at 24 hours

Group	Value	95% CI
DepoTXA 400mg	0
DepoTXA 800mg	0
DepoTXA 1200mg	0
IV Tranexamic Acid (TXA)	0

Number of subjects who had 90˚ active knee flexion at 48 hours

Group	Value	95% CI
DepoTXA 400mg	0
DepoTXA 800mg	0
DepoTXA 1200mg	0
IV Tranexamic Acid (TXA)	1

Number of subjects who had 90˚ active knee flexion at 72 hours

Group	Value	95% CI
DepoTXA 400mg	1
DepoTXA 800mg	0
DepoTXA 1200mg	0
IV Tranexamic Acid (TXA)	0

Number of subjects who had 90˚ passive knee flexion at 24 hours

Group	Value	95% CI
DepoTXA 400mg	0
DepoTXA 800mg	1
DepoTXA 1200mg	0
IV Tranexamic Acid (TXA)	1

Number of subjects who had 90˚ passive knee flexion at 48 hours

Group	Value	95% CI
DepoTXA 400mg	1
DepoTXA 800mg	0
DepoTXA 1200mg	0
IV Tranexamic Acid (TXA)	1

Number of subjects who had 90˚ passive knee flexion at 72 hours

Group	Value	95% CI
DepoTXA 400mg	2
DepoTXA 800mg	1
DepoTXA 1200mg	0
IV Tranexamic Acid (TXA)	0

Time to Complete Timed Up-and-Go (TUG) Test Secondary · Day 1; at approximately 8:00 am and 8:00 pm (±2 hours) daily from Day 2 through hospital discharge; and on Day 7

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

Baseline

Group	Value	95% CI
DepoTXA 400mg	16.4	± 4.25
DepoTXA 800mg	18.1	± 10.73
DepoTXA 1200mg	14.6	± 8.97
IV Tranexamic Acid (TXA)	15.4	± 6.92

Day 1

Group	Value	95% CI
DepoTXA 400mg	50.0	± NA
DepoTXA 800mg	80.0	± NA
DepoTXA 1200mg	40.0	± 7.07
IV Tranexamic Acid (TXA)	80.0	± NA

Day 2 - AM

Group	Value	95% CI
DepoTXA 400mg	47.5	± 10.61
DepoTXA 800mg	90.0	± 7.07
DepoTXA 1200mg	66.7	± 23.63
IV Tranexamic Acid (TXA)	85.0	± 21.88

Day 2- PM

Group	Value	95% CI
DepoTXA 400mg	48.0	± 14.14
DepoTXA 800mg	85.0	± 7.07
DepoTXA 1200mg	69.0	± 25.94
IV Tranexamic Acid (TXA)	41.0	± 6.08

Day 2 -Discharge

Group	Value	95% CI
DepoTXA 400mg	44.3	± 6.03
DepoTXA 800mg	51.1	± 32.85
DepoTXA 1200mg	61.3	± 31.76
IV Tranexamic Acid (TXA)	40.0	± 0.00

Day 7

Group	Value	95% CI
DepoTXA 400mg	28.4	± 11.64
DepoTXA 800mg	51.2	± 32.89
DepoTXA 1200mg	32.3	± 15.72
IV Tranexamic Acid (TXA)	13.1	± NA

Change in Knee and Thigh Measurements Secondary · 48 hours and Day 7

Leg difference in change from baseline is calculated by = (Operated Leg Change from Baseline) - (Non-Operated Leg Change from Baseline)

Leg Difference in Change from Baseline in Thigh Circumference (cm) at 48 hours

Group	Value	95% CI
DepoTXA 400mg	5.0	± 4.73
DepoTXA 800mg	6.7	± 6.37
DepoTXA 1200mg	3.4	± 4.54
IV Tranexamic Acid (TXA)	6.1	± 1.39

Leg Difference in Change from Baseline in Thigh Circumference (cm) at Day 7

Group	Value	95% CI
DepoTXA 400mg	4.3	± 1.70
DepoTXA 800mg	5.2	± 6.17
DepoTXA 1200mg	0.8	± 5.09
IV Tranexamic Acid (TXA)	3.3	± 3.18

Leg Difference in Change from Baseline in Knee Circumference at 48 hours

Group	Value	95% CI
DepoTXA 400mg	4.1	± 3.47
DepoTXA 800mg	5.8	± 5.37
DepoTXA 1200mg	2.2	± 4.85
IV Tranexamic Acid (TXA)	1.0	± 5.25

Leg Difference in Change from Baseline in Knee Circumference at Day 7

Group	Value	95% CI
DepoTXA 400mg	2.6	± 3.20
DepoTXA 800mg	3.8	± 8.25
DepoTXA 1200mg	-1.4	± 4.03
IV Tranexamic Acid (TXA)	4.3	± 0.35

Adverse events — posted to ClinicalTrials.gov

Time frame: From screening to postsurgical day 60. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DepoTXA 400mg

Serious: 0/4 (0%)

Deaths: 0/4

DepoTXA 800mg

Serious: 0/3 (0%)

Deaths: 0/3

DepoTXA 1200mg

Serious: 0/4 (0%)

Deaths: 0/4

IV Tranexamic Acid (TXA)

Serious: 0/4 (0%)

Deaths: 0/4

Other adverse events (14 terms — click to expand)

Reaction	System	DepoTXA 400mg	DepoTXA 800mg	DepoTXA 1200mg	IV Tranexamic Acid (TXA)
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—
Postprocedural hemorrhage	Injury, poisoning and procedural complications	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—
Gout	Metabolism and nutrition disorders	—	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—	—
Hypoesthesia	Nervous system disorders	—	—	—	—
Sinus arrhythmia	Cardiac disorders	—	—	—	—

Data from ClinicalTrials.gov NCT02922582 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pharmacological interventions for the prevention of bleeding in people undergoing elective hip or knee surgery: a systematic review and network meta-analysis.
Gibbs VN, Champaneria R, Sandercock J, Welton NJ, et al · · 2024 · cited 19× · PMID 38226724 · DOI 10.1002/14651858.cd013295.pub2

Verify or expand the search:

Other recruiting trials for Total Knee Arthroplasty

Currently open trials in the same condition.

NCT07524387 — Femoral Triangle Block vs Adductor Canal Block on Early Quadriceps Function After Total Knee Arthroplasty · NA · recruiting
NCT07511842 — REST-Knee: A Pilot RCT of 72-Hour Knee Immobilization and Pain Outcomes · NA · recruiting
NCT07324954 — Methylene Blue in Total Knee Arthroplasty (TKA) · Phase 1 · recruiting
NCT07336160 — ERAS-Based Preoperative Nutrition and Fasting in Total Knee Arthroplasty · NA · recruiting
NCT07371390 — Minimal Sedation During Knee Replacement Surgery · NA · recruiting

Other Pacira Pharmaceuticals, Inc trials

Trials by the same sponsor.

NCT06977568 — A Study to Evaluate an Intra-Articular Injection of ZILRETTA Versus Triamcinolone Acetonide, Immediate Release in Subjec · Phase 2 · terminated
NCT05456490 — Phase 1, Dose Escalation Study to Evaluate of Safety, Pharmacokinetics and Pharmacodynamics of Liposomal Bupivacaine 13. · Phase 1 · completed
NCT05157841 — Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy · Phase 3 · completed
NCT05139030 — Phase 3 Adductor Canal Block With EXPAREL in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty · Phase 3 · completed
NCT05495334 — Innovations in Genicular Outcomes Registry · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02922582 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pacira Pharmaceuticals, Inc
Last refreshed: 11 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02922582.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02922582

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Total Knee Arthroplasty

Other Pacira Pharmaceuticals, Inc trials

Verify against primary sources