Trial · NCT03793010

Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis

NCT03793010, Phase 3, Terminated, Pacira Pharmaceuticals, Inc; results first posted 2020-09-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis. Trials, record NCT03793010. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03793010

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis
NCT number: NCT03793010
Status: Terminated
Phases: Phase 3
Enrollment: 70 participants, actual
Lead sponsor: Pacira Pharmaceuticals, Inc
Conditions: Osteoarthritis, Hip
Interventions: FX006, Normal saline
First posted: 2019-01-04
Last updated: 2024-01-24
Results first posted: 2020-09-14
Limitations and caveats: This study was terminated early by the Sponsor due to occurrences of incomplete study drug administration. Only 15% of the planned study population had enrolled and no statistical evaluations reported due to insufficient sample size.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in WOMAC A (Pain) Score at Week 12	Baseline and Week 12	The change from baseline on the average Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (pain) score at Week 12. The average WOMAC A score is calculated by taking the average of five questions with a range from 0 (no pain) to 10 (extreme pain).
Secondary	Change in WOMAC C (Function) Score at Week 12	Baseline and Week 12	Change from Baseline on the WOMAC C (function) score at Week 12. The average WOMAC C score is calculated by taking the average of seventeen questions with a range from 0 (no difficulty) to 10 (extreme difficulty).
Secondary	PGIC Score at Week 12	12 Weeks	PGIC (Patient Global Impression of Change) at Week 12. The PGIC score has a range from 1(very much improved) to 7 (very much worse) and indicates the overall status of the patient since baseline.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in WOMAC A (Pain) Score at Week 12	Baseline and Week 12	All patients who received a full dose of study drug assigned to the FX006 32 mg arm and the placebo arm were included in the analysis. 68 total patients were included in the safety analysis. 55 of 68 patients had Week 12 assessments and are included in the primary and secondary outcomes analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in WOMAC C (Function) Score at Week 12	Baseline and Week 12	All patients who received a full dose of study drug assigned to the FX006 32 mg arm and the placebo arm were included in the analysis. 68 total patients were included in the safety population. 55 of 68 patients had week 12 assessments and are included in the primary and secondary outcomes analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	PGIC Score at Week 12	12 Weeks	All patients who received a full dose of study drug assigned to the FX006 32 mg arm and the placebo arm were included in the analysis. 68 total patients were included in the safety population. 55 of 68 patients had week 12 assessments and are included in the primary and secondary outcomes analysis.	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in WOMAC A (Pain) Score at Week 12	FX006	-1.85	95% Confidence Interval -2.99 to -0.71	score on a scale
Change in WOMAC A (Pain) Score at Week 12	Normal Saline	-2.16	95% Confidence Interval -3.22 to -1.09	score on a scale
Change in WOMAC C (Function) Score at Week 12	FX006	-1.56	95% Confidence Interval -2.73 to -0.40	score on a scale
Change in WOMAC C (Function) Score at Week 12	Normal Saline	-2.16	95% Confidence Interval -3.30 to -1.03	score on a scale
PGIC Score at Week 12	FX006	3.4	95% Confidence Interval 2.7 to 4.1	score on a scale
PGIC Score at Week 12	Normal Saline	3.4	95% Confidence Interval 2.8 to 4.1	score on a scale

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	FX006	35
Overall Study	STARTED	Normal Saline	35
Overall Study	Randomized But Not Dosed	FX006	2
Overall Study	Randomized But Not Dosed	Normal Saline	0
Overall Study	COMPLETED	FX006	7
Overall Study	COMPLETED	Normal Saline	8
Overall Study	NOT COMPLETED	FX006	28
Overall Study	NOT COMPLETED	Normal Saline	27

Source ClinicalTrials.gov

Adverse events82

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Thrombocytopenia	Blood and lymphatic system disorders	FX006	1	33
other	Thrombocytopenia	Blood and lymphatic system disorders	Normal Saline	0	35
other	Dry Mouth	Gastrointestinal disorders	FX006	1	33
other	Dry Mouth	Gastrointestinal disorders	Normal Saline	0	35
other	Dyspepsia	Gastrointestinal disorders	FX006	0	33
other	Dyspepsia	Gastrointestinal disorders	Normal Saline	1	35
other	Dysphagia	Gastrointestinal disorders	FX006	2	33
other	Dysphagia	Gastrointestinal disorders	Normal Saline	0	35
other	Peptic Ulcer	Gastrointestinal disorders	FX006	0	33
other	Peptic Ulcer	Gastrointestinal disorders	Normal Saline	1	35

1 to 10 of 82Source ClinicalTrials.gov

See all 82 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	FX006	0	33
Total, all-cause mortality	Normal Saline	0	35
Total, other adverse events	FX006	21	33
Total, other adverse events	Normal Saline	14	35
Total, serious adverse events	FX006	0	33
Total, serious adverse events	Normal Saline	0	35

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
FX006 vs Normal Saline: deaths from any cause	Trial comparisons
FX006 vs Normal Saline: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03793010

GET https://conductscience.org/api/trials/v1/NCT03793010/events?page=2

API reference For AI assistants