Adults 35 to 80, any sex, with Osteoarthritis of the Shoulder or Adhesive Capsulitis. 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.
Change From Baseline in the Weekly Mean of the Average Daily Shoulder Pain With Movement ScoreSecondary· Baseline to 12 weeks
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "No pain" and 10 indicates "Worst possible pain."
Group
Value
95% CI
FX006 32mg in Glenohumeral OA Population
-3.54
± 2.477
Normal Saline in Glenohumeral OA Population
-0.88
± 1.237
FX006 32mg in Adhesive Capsulitis Population
-4.05
± 2.648
Normal Saline in Adhesive Capsulitis Population
-1.58
± 2.003
Change From Baseline in the SPADI Pain Subscale at Week 12Secondary· Baseline to 12 weeks
Shoulder Pain and Disability Index (SPADI) Pain scale is measured using 5 11-point NRS questions where 0 indicates "no pain" and 10 indicates "worst pain imaginable." The Pain and Disability Subscales are presented as a percentage of the total possible score. The Total SPADI score ranges from 0 (best) to 100 (worst) is computed by taking the means of the Pain and Disability Subscale scores.
Group
Value
95% CI
FX006 32mg in Glenohumeral OA Population
-32.00
± 21.385
Normal Saline in Glenohumeral OA Population
-9.33
± 26.633
FX006 32mg in Adhesive Capsulitis Population
-52.00
± 49.585
Normal Saline in Adhesive Capsulitis Population
-40.00
± 5.657
Change From Baseline in the SPADI Disability Subscale at Week 12Secondary· Baseline to 12 weeks
Shoulder Pain and Disability Index (SPADI) Disability scale is measured using 8 11-point NRS questions where 0 indicates "no difficulty" and 10 indicates "so difficult it requires help." The Pain and Disability Subscales are presented as a percentage of the total possible score. The Total SPADI score ranges from 0 (best) to 100 (worst) is computed by taking the means of the Pain and Disability Subscale scores.
Group
Value
95% CI
FX006 32mg in Glenohumeral OA Population
-32.29
± 9.435
Normal Saline in Glenohumeral OA Population
-10.42
± 17.559
FX006 32mg in Adhesive Capsulitis Population
-50.94
± 31.842
Normal Saline in Adhesive Capsulitis Population
-50.00
± 21.213
Patient Global Impression of Change (PGIC) Score at Week 12Secondary· Baseline to 12 weeks
PGIC is measured using a 7-point NRS where 1 indicates "very much improved" and 7 indicates "very much worse."
Group
Value
95% CI
FX006 32mg in Glenohumeral OA Population
2.7
± 1.51
Normal Saline in Glenohumeral OA Population
3.3
± 1.15
FX006 32mg in Adhesive Capsulitis Population
1.5
± 0.58
Normal Saline in Adhesive Capsulitis Population
2.5
± 0.71
Change From Baseline in the Range of Motion (ROM) of Active External Rotation at Week 12Secondary· Baseline to 12 weeks
Measured using a goniometer which is a device that measures ROM joint angles
Group
Value
95% CI
FX006 32mg in Glenohumeral OA Population
-4.76
± 13.068
Normal Saline in Glenohumeral OA Population
7.87
± 26.307
FX006 32mg in Adhesive Capsulitis Population
68.70
± 81.850
Normal Saline in Adhesive Capsulitis Population
-4.60
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from the time of informed consent until the end of patient participation in the study up to 24 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a double-blind study to evaluate the efficacy and safety of FX006 in patients with glenohumeral osteoarthritis (OA) or shoulder adhesive capsulitis (AC).
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04182672 — Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis
· Phase 2
· completed
NCT03793010 — Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis
· Phase 3
· terminated
Other recruiting trials for Osteoarthritis of the Shoulder
Currently open trials in the same condition.
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· recruiting
NCT04228419 — TSA vs RSA in Glenohumeral Osteoarthritis
· NA
· recruiting
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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: 24 January 2024
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/NCT04160091.