Trial · NCT02205814
Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee
NCT02205814, Phase 2, Completed, Menarini Group; results first posted 2015-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee. Trials, record NCT02205814. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02205814
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee
- NCT number
- NCT02205814
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 436 participants, actual
- Lead sponsor
- Menarini Group
- Conditions
- Knee Osteoarthritis
- Interventions
- Fasitibant- low dose, Fasitibant- intermediate dose, Fasitibant- high dose, Placebo comparator
- First posted
- 2014-07-31
- Last updated
- 2015-11-03
- Other registries' IDs
- eudract:2013-004999-35
- Results first posted
- 2015-09-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in WOMAC A | from baseline up to 2 weeks after randomisation | The validated Western Ontario and McMaster University questionnaire (WOMAC) was used to measure total knee pain choosing its visual analogue scale version (VAS). The WOMAC VA 3.1 A subscore (WOMAC A) ranges from 0 to 500 mm (summing up five VAS 0-100 mm) with higher scores indicating more pain. |
| Secondary | Change in WOMAC INDEX | from baseline up to 6 weeks after randomisation | The WOMAC VA 3.1 Index score (WOMAC INDEX) is the sum of WOMAC A (total pain), WOMAC B (stiffness) and WOMAC C (functional impairment) subscores. The WOMAC INDEX score ranges from 0 to 2400 mm, with higher scores indicating higher disease burden. |
| Secondary | Responder Rate According to OMERACT-OARSI Criteria | from baseline up to 6 weeks after randomisation | Percentage of responders according to Outcome Measures in Rheumatology-Osteoarthritis Research Society International criteria (OMERACT-OARSI criteria). Patients with at least 50 % improvement in pain or in function scores are considered responders. Alternatively, patients are considered responders if they show at least 20% improvement in at least two of the following scores: pain, function and Patients's Global Assessment (PGA) scores. |
| Secondary | Euro Quality of Life Questionnaire (EQ-5D-5L) Responder Rate | from baseline up to 6 weeks after randomisation | Response based on change ≥ 20 % from baseline for EQ-5D-5L index value |
Source ClinicalTrials.gov
Outcomes4
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 | from baseline up to 2 weeks after randomisation | The primary efficacy analysis was performed on the ITT-population (n=431). | units on a scale | MEAN |
| SECONDARY | Change in WOMAC INDEX | from baseline up to 6 weeks after randomisation | The secondary efficacy analysis was performed on the ITT population (n=431). | units on a scale | MEAN |
| SECONDARY | Responder Rate According to OMERACT-OARSI Criteria | from baseline up to 6 weeks after randomisation | The secondary efficacy variables were analysed in the ITT population (n=431). | percentage of responders | NUMBER |
| SECONDARY | Euro Quality of Life Questionnaire (EQ-5D-5L) Responder Rate | from baseline up to 6 weeks after randomisation | The secondary efficacy analysis was performed on the ITT-population (n=431). | percentage of responders | NUMBER |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in WOMAC A | Fasitibant Low Dose | Week 1 after randomisation | -91.8 | Standard Deviation 101.85 | units on a scale |
| Change in WOMAC A | Fasitibant Intermediate Dose | Week 1 after randomisation | -110.0 | Standard Deviation 99.48 | units on a scale |
| Change in WOMAC A | Fasitibant High Dose | Week 1 after randomisation | -109.8 | Standard Deviation 94.65 | units on a scale |
| Change in WOMAC A | PLACEBO | Week 1 after randomisation | -93.7 | Standard Deviation 94.15 | units on a scale |
| Change in WOMAC A | Fasitibant Low Dose | Week 2 after randomisation | -106.1 | Standard Deviation 101.88 | units on a scale |
| Change in WOMAC A | Fasitibant Intermediate Dose | Week 2 after randomisation | -131.5 | Standard Deviation 96.41 | units on a scale |
| Change in WOMAC A | Fasitibant High Dose | Week 2 after randomisation | -115.9 | Standard Deviation 104.61 | units on a scale |
| Change in WOMAC A | PLACEBO | Week 2 after randomisation | -117.2 | Standard Deviation 90.15 | units on a scale |
| Change in WOMAC INDEX | Fasitibant Low Dose | Week 1 after randomisation | -396.0 | Standard Deviation 464.24 | units on a scale |
| Change in WOMAC INDEX | Fasitibant Intermediate Dose | Week 1 after randomisation | -460.5 | Standard Deviation 469.68 | units on a scale |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fasitibant Low Dose | 110 | |
| Overall Study | STARTED | Fasitibant Intermediate Dose | 110 | |
| Overall Study | STARTED | Fasitibant High Dose | 108 | |
| Overall Study | STARTED | PLACEBO | 108 | |
| Overall Study | COMPLETED | Fasitibant Low Dose | 108 | |
| Overall Study | COMPLETED | Fasitibant Intermediate Dose | 109 | |
| Overall Study | COMPLETED | Fasitibant High Dose | 103 | |
| Overall Study | COMPLETED | PLACEBO | 104 | |
| Overall Study | NOT COMPLETED | Fasitibant Low Dose | 2 | |
| Overall Study | NOT COMPLETED | Fasitibant Intermediate Dose | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events128
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 | Nasopharyngitis | Infections and infestations | Fasitibant Low Dose | 4 | 110 | 4 |
| other | Nasopharyngitis | Infections and infestations | Fasitibant Intermediate Dose | 17 | 110 | 18 |
| other | Nasopharyngitis | Infections and infestations | Fasitibant High Dose | 11 | 108 | 11 |
| other | Nasopharyngitis | Infections and infestations | PLACEBO | 13 | 107 | 13 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fasitibant Low Dose | 4 | 110 | 6 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fasitibant Intermediate Dose | 7 | 110 | 7 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fasitibant High Dose | 5 | 108 | 6 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | PLACEBO | 8 | 107 | 8 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Fasitibant Low Dose | 2 | 110 | 2 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Fasitibant Intermediate Dose | 4 | 110 | 5 |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fasitibant Low Dose | ||
| Total, all-cause mortality | Fasitibant Intermediate Dose | ||
| Total, all-cause mortality | Fasitibant High Dose | ||
| Total, all-cause mortality | PLACEBO | ||
| Total, other adverse events | Fasitibant Low Dose | 28 | 110 |
| Total, other adverse events | Fasitibant Intermediate Dose | 46 | 110 |
| Total, other adverse events | Fasitibant High Dose | 36 | 108 |
| Total, other adverse events | PLACEBO | 44 | 107 |
| Total, serious adverse events | Fasitibant Low Dose | 2 | 110 |
| Total, serious adverse events | Fasitibant Intermediate Dose | 2 | 110 |
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/NCT02205814
GET https://conductscience.org/api/trials/v1/NCT02205814/results?page=2