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This multicenter, randomized, double-blind study will be performed in approximately 600 subjects with chronic idiopathic osteoarthritis (OA) of the knee. An open-label safety extension will follow.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUFLEXXA™ Double-blind | Experimental | Each subject received 3 single-dose injections of EUFLEXXA™ into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection. |
|
| Placebo Double-blind | Placebo Comparator | Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection. |
|
| EUFLEXXA™ Open Label | Experimental | All patients who participated in the 26 week double-blind study (including participants randomized to the placebo treatment group) and elected to participate in the open label extension, received three injections of EUFLEXXA™ in the target knee. Injections were given once a week on weeks 26, 27 and 28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUFLEXXA™ | Device | EUFLEXXA™ is supplied in a single-dose syringe containing 20 mg/2 ml of 1% sodium hyaluronate (molecular weight 2.4-3.6 MD); sodium chloride, 17 mg; disodium hydrogen phosphate dodecahydrate, 1.12 mg; sodium dihydrogen phosphate dihydrate, 0.1 mg; enough water for injection to make 2.0 ml. EUFLEXXA™ is supplied in 2.25 ml nominal volume, disposable prefilled glass syringes containing 2 mL of EUFLEXXA™. Only the contents of the syringe are sterile. EUFLEXXA™ is nonpyrogenic. See package insert for further details. |
| Measure | Description | Time Frame |
|---|---|---|
| Observed Pain Scores on 50-foot Walk Test During the Double-blind Study | The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were evaluated on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed. | Weeks 0, 26 |
| Percent Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study | The percent difference in participant pain recorded by the participant during a walk of 50 feet in length between the baseline (week 0) and week 26 scores. Scores are measured on a visual analog scale of 100 millimeters; a score of 0 millimeters meaning no pain was observed; a score of 100 millimeters meaning extreme pain was observed. | Weeks 0 and 26 |
| Shifts From Extension Study Baseline (Week 26) in Range of Motion Findings at Week 52 | Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Range of motion indicates the flexibility of the knee, and is measured by the number of degrees between when the knee is hyper-extended and when the knee is flexed. | weeks 26 and 52 |
| Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Tenderness at Week 52 | Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Tenderness of the knee was subjectively rated by participants as none, mild, moderate or severe. | weeks 26 and 52 |
| Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Local Warmth at Week 52 | Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Local warmth of the target knee was recorded as Yes (warmth present) or No (knee was not warmer than expected). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Screening in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study | The percent difference in participant pain recorded by the participant during a walk of 50 feet in length between the screening (week -1) and week 26 scores. Scores are measured on a visual analog scale of 100 millimeters; a score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed. |
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Inclusion Criteria:
Chronic OA of target knee confirmed by ACR Criteria
Pain due to OA in target knee present for at least 6 months:
• Moderate to severe pain score of 41 mm to 90 mm recorded on a 100 mm VAS immediately following a 50-foot walk
A bilateral standing AP X-ray confirming OA of the target knee-obtained within a 6-month period prior to the Screening Visit-and a grade of 2 or 3 according to the Kellgren and Lawrence Grading Scale
Ability and willingness to use only acetaminophen as the analgesic (rescue) study medication
Ability to perform procedures required of the pain index evaluations (unassisted walking 50 feet on a flat surface and going up and down stairs).
Willingness and ability to complete efficacy and safety questionnaires and ability to read and understand study instructions
Signed study-specific Subject Informed Consent Form
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Los Angeles | California | 90025-1670 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21820521 | Result | Altman RD, Rosen JE, Bloch DA, Hatoum HT. Safety and efficacy of retreatment with a bioengineered hyaluronate for painful osteoarthritis of the knee: results of the open-label Extension Study of the FLEXX Trial. Osteoarthritis Cartilage. 2011 Oct;19(10):1169-75. doi: 10.1016/j.joca.2011.07.001. Epub 2011 Jul 23. |
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A total of 821 patients were screened.
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| ID | Title | Description |
|---|---|---|
| FG000 | EUFLEXXA™ Double-blind | Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection. |
| FG001 | Placebo Double-blind | Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection. |
| FG002 | EUFLEXXA™ Extension Study | Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind |
|
| |||||||||||||||||||||
| Open-label Extension |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EUFLEXXA™ Double-blind | Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection. |
| BG001 | Placebo Double-blind |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Observed Pain Scores on 50-foot Walk Test During the Double-blind Study | The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were evaluated on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed. | Intent to treat (ITT) population. | Posted | Mean | Standard Deviation | units on a scale | Weeks 0, 26 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EUFLEXXA™ Double-blind | Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| placebo | Device | Placebo is supplied in a disposable prefilled glass syringe. Each single-dose syringe will contain 2 mL of phosphate buffered saline. Only the contents of the syringe are sterile. |
|
| weeks 26 and 52 |
| Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Redness at Week 52 | Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Redness of the knee was subjectively rated as Yes (knee was red) and No (knee was not red). | weeks 26 and 52 |
| weeks -1 and 26 |
| Percent Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study for a Subpopulation of Participants With More Severe Knee Pain | Percent difference in participant pain during a walk of 50 feet in length between the mean screening (week -1) and baseline(week 0) scores, and week 26 scores. Scores are recorded by participants and measured on a visual analog scale of 100 millimeters, with 0 millimeters meaning there was no pain observed; 100 millimeters meaning extreme pain was observed. | weeks -1, 0, and 26 |
| Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 12 | Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter. | Week 12 |
| Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 26 | Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter. | Week 26 |
| Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Western Ontario McMaster University Osteoarthritis Index (WOMAC A) Pain Scale at Week 12 | Responders are identified based on a calculation of three scales: WOMAC (A) pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter. | Week 12 |
| Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Western Ontario McMaster University Osteoarthritis Index (WOMAC A) Pain Scale at Week 26 | Responders are identified based on a calculation of three scales: WOMAC (A) pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter. | week 26 |
| Change From Baseline in Patient Global Assessment of Knee Pain at Week 26 | Participant assessment of knee pain evaluated on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain. | Weeks 0 and 26 |
| Change From Baseline in the Number of Tablets of Rescue Medication Used at Week 26. | The change in the number of tablets of 500 milligram acetaminophen used in a week as rescue medication is compared at weeks 0 and weeks 26. | Weeks 0 and 26 |
| Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Physical Function (PF) Score at Week 26 | The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' physical function. The questionnaire is completed by participants. | Weeks 0, 26 |
| Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Bodily Pain(BP) Score at Week 26 | The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' bodily pain scores. The questionnaire is completed by participants. | weeks 0 and 26 |
| Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) General Health(GH) Score at Week 26 | The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' general health scores. The questionnaire is completed by participants. | weeks 0 and 26 |
| Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score at Week 26 | The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. The questionnaire is completed by participants. This table summarizes the change from baseline in participants' physical health. | Weeks 0, 26 |
| Number of Participants With 20 Millimeter or Greater Improvement in Pain Scores on the 50-foot Walk Test | Yes represents the number of participants whose pain during a walk of 50 feet in length was improved at week 26 over baseline by at least 20 millimeters. Pain was evaluated on a 100 millimeter visual analog scale by participants. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed. | Weeks 0 and 26 |
| Observed Pain Scores on the 50-foot Walk Test During the Extension Study | Participant pain during a walk of 50 feet in length was evaluated by participants on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed. | Baseline (week 26), week 52 |
| Mean Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Extension Study | The mean difference in participant pain as measured by participants during a walk of 50 feet in length between the baseline (week 26 pre-dose) and week 52 scores. Scores are measured on a visual analog scale of 100 millimeters, with a score of 0 millimeters meaning there was no pain observed; a score of 100 millimeters meaning extreme pain was observed. | Extension baseline (week 26), week 52 |
| Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 52 | Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer:YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter. | Week 52 (Extension Study) |
| Change From Baseline (Extension Study Week 26) in Use of Rescue Medication at Week 52. | The change in the number of tablets of study-specific acetaminophen taken per week as a rescue medication from knee pain. | Extension baseline (week 26 pre-dose), week 52 |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Use of exclusionary medication |
|
| Other |
|
| Data could not be retrieved |
|
| NOT COMPLETED |
|
|
Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Body mass index (BMI) is a measure of body fat based on height and weight that applies to both adult men and women. Body mass index is calculated as weight / (height times height). | Mean | Standard Deviation | kilograms/meters square |
|
| Weight | Mean body weight of study participants in kilograms | Mean | Standard Deviation | kilograms |
|
| Placebo Double-blind |
Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection. |
|
|
| Secondary | Percent Change From Screening in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study | The percent difference in participant pain recorded by the participant during a walk of 50 feet in length between the screening (week -1) and week 26 scores. Scores are measured on a visual analog scale of 100 millimeters; a score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed. | Intent to treat population | Posted | Mean | Standard Deviation | percent change from screening value | weeks -1 and 26 |
|
|
|
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| Secondary | Percent Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study for a Subpopulation of Participants With More Severe Knee Pain | Percent difference in participant pain during a walk of 50 feet in length between the mean screening (week -1) and baseline(week 0) scores, and week 26 scores. Scores are recorded by participants and measured on a visual analog scale of 100 millimeters, with 0 millimeters meaning there was no pain observed; 100 millimeters meaning extreme pain was observed. | Intent to treat population. A subpopulation of patients with more severe knee pain, as measured by having a greater than or equal to 41 millimeter screening score on the 50-foot walk test. | Posted | Mean | Standard Deviation | percentage change from baseline score | weeks -1, 0, and 26 |
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| Secondary | Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 12 | Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter. | Intent to treat population | Posted | Number | participants | Week 12 |
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| Secondary | Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 26 | Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter. | Intent to treat population | Posted | Number | participants | Week 26 |
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| Secondary | Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Western Ontario McMaster University Osteoarthritis Index (WOMAC A) Pain Scale at Week 12 | Responders are identified based on a calculation of three scales: WOMAC (A) pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter. | Intent to treat population | Posted | Number | participants | Week 12 |
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| Secondary | Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Western Ontario McMaster University Osteoarthritis Index (WOMAC A) Pain Scale at Week 26 | Responders are identified based on a calculation of three scales: WOMAC (A) pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter. | Intent to treat population | Posted | Number | participants | week 26 |
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| Primary | Percent Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study | The percent difference in participant pain recorded by the participant during a walk of 50 feet in length between the baseline (week 0) and week 26 scores. Scores are measured on a visual analog scale of 100 millimeters; a score of 0 millimeters meaning no pain was observed; a score of 100 millimeters meaning extreme pain was observed. | Intent to treat population. | Posted | Mean | Standard Deviation | percent change from baseline value | Weeks 0 and 26 |
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| Primary | Shifts From Extension Study Baseline (Week 26) in Range of Motion Findings at Week 52 | Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Range of motion indicates the flexibility of the knee, and is measured by the number of degrees between when the knee is hyper-extended and when the knee is flexed. | Safety population which includes all participants who received at least one injection during the extension phase of the study. | Posted | Number | participants | weeks 26 and 52 |
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| Primary | Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Tenderness at Week 52 | Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Tenderness of the knee was subjectively rated by participants as none, mild, moderate or severe. | Safety population which includes all participants who received at least one injection during the extension phase of the study. | Posted | Number | participants | weeks 26 and 52 |
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| Primary | Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Local Warmth at Week 52 | Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Local warmth of the target knee was recorded as Yes (warmth present) or No (knee was not warmer than expected). | Safety population which includes all participants who received at least one injection during the extension phase of the study. | Posted | Number | participants | weeks 26 and 52 |
|
|
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| Primary | Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Redness at Week 52 | Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Redness of the knee was subjectively rated as Yes (knee was red) and No (knee was not red). | Safety population which includes all participants who received at least one injection during the extension phase of the study. | Posted | Number | participants | weeks 26 and 52 |
|
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| Secondary | Change From Baseline in Patient Global Assessment of Knee Pain at Week 26 | Participant assessment of knee pain evaluated on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain. | Intent to treat population | Posted | Mean | Standard Deviation | units on a scale | Weeks 0 and 26 |
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|
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| Secondary | Change From Baseline in the Number of Tablets of Rescue Medication Used at Week 26. | The change in the number of tablets of 500 milligram acetaminophen used in a week as rescue medication is compared at weeks 0 and weeks 26. | Intent to treat population | Posted | Mean | Standard Deviation | tablets per week | Weeks 0 and 26 |
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| Secondary | Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Physical Function (PF) Score at Week 26 | The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' physical function. The questionnaire is completed by participants. | Intent to treat population | Posted | Mean | Standard Deviation | units on a scale | Weeks 0, 26 |
|
|
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| Secondary | Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Bodily Pain(BP) Score at Week 26 | The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' bodily pain scores. The questionnaire is completed by participants. | Intent to treat population | Posted | Mean | Standard Deviation | units on a scale | weeks 0 and 26 |
|
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| Secondary | Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) General Health(GH) Score at Week 26 | The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' general health scores. The questionnaire is completed by participants. | Intent to treat population | Posted | Mean | Standard Deviation | units on a scale | weeks 0 and 26 |
|
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| Secondary | Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score at Week 26 | The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. The questionnaire is completed by participants. This table summarizes the change from baseline in participants' physical health. | Intent to treat population | Posted | Mean | Standard Deviation | units on a scale | Weeks 0, 26 |
|
|
|
| Secondary | Number of Participants With 20 Millimeter or Greater Improvement in Pain Scores on the 50-foot Walk Test | Yes represents the number of participants whose pain during a walk of 50 feet in length was improved at week 26 over baseline by at least 20 millimeters. Pain was evaluated on a 100 millimeter visual analog scale by participants. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed. | Intent to treat population | Posted | Number | participants | Weeks 0 and 26 |
|
|
|
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| Secondary | Observed Pain Scores on the 50-foot Walk Test During the Extension Study | Participant pain during a walk of 50 feet in length was evaluated by participants on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed. | Intent to treat population. No imputation for missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline (week 26), week 52 |
|
|
|
| Secondary | Mean Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Extension Study | The mean difference in participant pain as measured by participants during a walk of 50 feet in length between the baseline (week 26 pre-dose) and week 52 scores. Scores are measured on a visual analog scale of 100 millimeters, with a score of 0 millimeters meaning there was no pain observed; a score of 100 millimeters meaning extreme pain was observed. | Intent to treat population. No imputation for missing values. | Posted | Mean | Standard Deviation | units on a scale | Extension baseline (week 26), week 52 |
|
|
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| Secondary | Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 52 | Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer:YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter. | Intent to treat population. | Posted | Number | participants | Week 52 (Extension Study) |
|
|
|
| Secondary | Change From Baseline (Extension Study Week 26) in Use of Rescue Medication at Week 52. | The change in the number of tablets of study-specific acetaminophen taken per week as a rescue medication from knee pain. | Intent to treat population | Posted | Mean | Standard Deviation | tablets per week | Extension baseline (week 26 pre-dose), week 52 |
|
|
|
| 10 |
| 293 |
| 27 |
| 293 |
| EG001 | Placebo Double-blind | Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection. | 9 | 295 | 35 | 295 |
| EG002 | EUFLEXXA™ Extension Study | Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection. | 12 | 433 | 43 | 433 |
| angina unstable | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| arrhythmia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| salivary gland mass | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| umbilical hernia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| appendicitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| gastroenteritis salmonella | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| ankle fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| lower limb fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| transient ischaemic attack | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| hysterectomy | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| oophorectomy bilateral | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| mitral valve incompetence | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| vertigo | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| cholelithiasis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| bacterial bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| cerebrovascular accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| cholecystectomy | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| intervertebral disc operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| spinal fusion surgery | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript.
| Title | Measurements |
|---|---|
|
| <45 degrees week 26 / >135 degrees week 52 |
|
| >135 degrees week 26 / 90-135 degrees week 52 |
|
| 90-135 degrees week 26/ 90-135 degrees week 52 |
|
| 45-89 degrees week 26/ 90-135 degrees week 52 |
|
| <45 degrees week 26/ 90-135 degrees week 52 |
|
| >135 degrees week 26 / 45-89 degrees week 52 |
|
| 90-135 degrees week 26 / 45-89 degrees week 52 |
|
| 45-89 degrees week 26 / 45-89 degrees week 52 |
|
| <45 degrees week 26 / 45-89 degrees week 52 |
|
| >135 degrees week 26 / <45 degrees week 52 |
|
| 90-135 degrees week 26 / <45 degrees week 52 |
|
| 45-89 degrees week 26 / <45 degrees week 52 |
|
| <45 degrees week 26 / <45 degrees week 52 |
|
| Title | Measurements |
|---|---|
|
| Severe week 26 / none week 52 |
|
| None week 26 / mild week 52 |
|
| Mild week 26 / mild week 52 |
|
| Moderate week 26 / mild week 52 |
|
| Severe week 26 / mild week 52 |
|
| None week 26 / moderate week 52 |
|
| Mild week 26 / moderate week 52 |
|
| Moderate week 26 / moderate week 52 |
|
| Severe week 26 / moderate week 52 |
|
| None week 26 / severe week 52 |
|
| Mild week 26 / severe week 52 |
|
| Moderate week 26 / severe week 52 |
|
| Severe week 26 / severe week 52 |
|
| Title | Measurements |
|---|---|
|
| No week 26 / no week 52 |
|
| Title | Measurements |
|---|---|
|
| No week 26 / no week 52 |
|