Trial · NCT04160091
Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis
NCT04160091, Phase 2, Terminated, Pacira Pharmaceuticals, Inc; results first posted 2021-11-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis. Trials, record NCT04160091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04160091
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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 Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis
- NCT number
- NCT04160091
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Conditions
- Osteoarthritis of the Shoulder, Adhesive Capsulitis
- Interventions
- FX006, Normal Saline
- First posted
- 2019-11-12
- Last updated
- 2024-01-24
- Results first posted
- 2021-11-30
- Limitations and caveats
This study was terminated early by the Sponsor due to the COVID-19 pandemic. Summary statistics were calculated for available data, but given that only approximately 8% of the planned study population had enrolled and there no conclusions can be drawn from this study.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve of the Change From Baseline in the Weekly Mean of the Daily Shoulder Pain With Movement | Baseline to 8 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." |
| Secondary | Change From Baseline in the Weekly Mean of the Average Daily Shoulder Pain With Movement Score | 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." |
| Secondary | Change From Baseline in the SPADI Pain Subscale at Week 12 | 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. |
| Secondary | Change From Baseline in the SPADI Disability Subscale at Week 12 | 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. |
| Secondary | Patient Global Impression of Change (PGIC) Score at Week 12 | Baseline to 12 weeks | PGIC is measured using a 7-point NRS where 1 indicates "very much improved" and 7 indicates "very much worse." |
| Secondary | Change From Baseline in the Range of Motion (ROM) of Active External Rotation at Week 12 | Baseline to 12 weeks | Measured using a goniometer which is a device that measures ROM joint angles |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve of the Change From Baseline in the Weekly Mean of the Daily Shoulder Pain With Movement | Baseline to 8 weeks | Due to the early termination of the study, this endpoint was not analyzed. Change from baseline in the weekly mean of the average daily shoulder pain with movement score is included in Outcome Measure 2 | ||
| SECONDARY | Change From Baseline in the Weekly Mean of the Average Daily Shoulder Pain With Movement Score | Baseline to 12 weeks | All patients who received a dose of study drug assigned to the FX006 32 mg and the Placebo arm were included in the analysis. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the SPADI Pain Subscale at Week 12 | Baseline to 12 weeks | All patients who received a dose of study drug assigned to the FX006 32 mg and the Placebo arm were included in the analysis. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the SPADI Disability Subscale at Week 12 | Baseline to 12 weeks | All patients who received a dose of study drug assigned to the FX006 32 mg and the Placebo arm were included in the analysis. | score on a scale | MEAN |
| SECONDARY | Patient Global Impression of Change (PGIC) Score at Week 12 | Baseline to 12 weeks | All patients who received a dose of study drug assigned to the FX006 32 mg and the Placebo arm were included in the analysis. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Range of Motion (ROM) of Active External Rotation at Week 12 | Baseline to 12 weeks | All patients who received a dose of study drug assigned to the FX006 32 mg and the Placebo arm were included in the analysis. | Degrees | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Weekly Mean of the Average Daily Shoulder Pain With Movement Score | FX006 32mg in Glenohumeral OA Population | -3.54 | Standard Deviation 2.477 | score on a scale | |
| Change From Baseline in the Weekly Mean of the Average Daily Shoulder Pain With Movement Score | Normal Saline in Glenohumeral OA Population | -0.88 | Standard Deviation 1.237 | score on a scale | |
| Change From Baseline in the Weekly Mean of the Average Daily Shoulder Pain With Movement Score | FX006 32mg in Adhesive Capsulitis Population | -4.05 | Standard Deviation 2.648 | score on a scale | |
| Change From Baseline in the Weekly Mean of the Average Daily Shoulder Pain With Movement Score | Normal Saline in Adhesive Capsulitis Population | -1.58 | Standard Deviation 2.003 | score on a scale | |
| Change From Baseline in the SPADI Pain Subscale at Week 12 | FX006 32mg in Glenohumeral OA Population | -32.00 | Standard Deviation 21.385 | score on a scale | |
| Change From Baseline in the SPADI Pain Subscale at Week 12 | Normal Saline in Glenohumeral OA Population | -9.33 | Standard Deviation 26.633 | score on a scale | |
| Change From Baseline in the SPADI Pain Subscale at Week 12 | FX006 32mg in Adhesive Capsulitis Population | -52.00 | Standard Deviation 49.585 | score on a scale | |
| Change From Baseline in the SPADI Pain Subscale at Week 12 | Normal Saline in Adhesive Capsulitis Population | -40.00 | Standard Deviation 5.657 | score on a scale | |
| Change From Baseline in the SPADI Disability Subscale at Week 12 | FX006 32mg in Glenohumeral OA Population | -32.29 | Standard Deviation 9.435 | score on a scale | |
| Change From Baseline in the SPADI Disability Subscale at Week 12 | Normal Saline in Glenohumeral OA Population | -10.42 | Standard Deviation 17.559 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FX006 32mg in Glenohumeral OA Population | 7 | |
| Overall Study | STARTED | Normal Saline in Glenohumeral OA Population | 3 | |
| Overall Study | STARTED | FX006 32mg in Adhesive Capsulitis Population | 5 | |
| Overall Study | STARTED | Normal Saline in Adhesive Capsulitis Population | 4 | |
| Overall Study | COMPLETED | FX006 32mg in Glenohumeral OA Population | 0 | |
| Overall Study | COMPLETED | Normal Saline in Glenohumeral OA Population | 0 | |
| Overall Study | COMPLETED | FX006 32mg in Adhesive Capsulitis Population | 0 | |
| Overall Study | COMPLETED | Normal Saline in Adhesive Capsulitis Population | 0 | |
| Overall Study | NOT COMPLETED | FX006 32mg in Glenohumeral OA Population | 7 | |
| Overall Study | NOT COMPLETED | Normal Saline in Glenohumeral OA Population | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events28
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 | Events |
|---|---|---|---|---|---|---|
| other | Migraine | Nervous system disorders | FX006 32mg in Glenohumeral OA Population | 1 | 7 | 1 |
| other | Migraine | Nervous system disorders | Normal Saline in Glenohumeral OA Population | 0 | 3 | 0 |
| other | Migraine | Nervous system disorders | FX006 32mg in Adhesive Capsulitis Population | 0 | 5 | 0 |
| other | Migraine | Nervous system disorders | Normal Saline in Adhesive Capsulitis Population | 0 | 4 | 0 |
| other | Ligament Sprain | Injury, poisoning and procedural complications | FX006 32mg in Glenohumeral OA Population | 0 | 7 | 0 |
| other | Ligament Sprain | Injury, poisoning and procedural complications | Normal Saline in Glenohumeral OA Population | 0 | 3 | 0 |
| other | Ligament Sprain | Injury, poisoning and procedural complications | FX006 32mg in Adhesive Capsulitis Population | 1 | 5 | 1 |
| other | Ligament Sprain | Injury, poisoning and procedural complications | Normal Saline in Adhesive Capsulitis Population | 0 | 4 | 0 |
| other | Pain in Extremity | Musculoskeletal and connective tissue disorders | FX006 32mg in Glenohumeral OA Population | 0 | 7 | 0 |
| other | Pain in Extremity | Musculoskeletal and connective tissue disorders | Normal Saline in Glenohumeral OA Population | 0 | 3 | 0 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FX006 32mg in Glenohumeral OA Population | 0 | 7 |
| Total, all-cause mortality | Normal Saline in Glenohumeral OA Population | 0 | 3 |
| Total, all-cause mortality | FX006 32mg in Adhesive Capsulitis Population | 0 | 5 |
| Total, all-cause mortality | Normal Saline in Adhesive Capsulitis Population | 0 | 4 |
| Total, other adverse events | FX006 32mg in Glenohumeral OA Population | 1 | 7 |
| Total, other adverse events | Normal Saline in Glenohumeral OA Population | 0 | 3 |
| Total, other adverse events | FX006 32mg in Adhesive Capsulitis Population | 2 | 5 |
| Total, other adverse events | Normal Saline in Adhesive Capsulitis Population | 0 | 4 |
| Total, serious adverse events | FX006 32mg in Glenohumeral OA Population | 0 | 7 |
| Total, serious adverse events | Normal Saline in Glenohumeral OA Population | 0 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT04160091
GET https://conductscience.org/api/trials/v1/NCT04160091/events?page=2