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The purpose of the study is to assess the safety and efficacy profiles of new single-injection volumes of Durolane in patients with knee OA.
To assess the safety and efficacy profiles of different volumes of Durolane in patients with knee OA and compare with the current standard single-injection of the product. The study aims to investigate whether different volumes of Durolane compared to the standard injection volume will improve the benefit/risk profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Durolane 3ml | Experimental | Durolane 3 ml is an Intraarticular hyaluronic acid |
|
| Durolane 4.5 | Experimental | Durolane 4.5 is an Intraarticular hyaluronic acid |
|
| Durolane 6 ml | Experimental | Durolane 6 ml is an Intraarticular hyaluronic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml | Device | Durolane is an intraarticular hyaluronic acid preparation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Pain Over 26 Weeks (Change From Baseline) | The study aims to compare the change of pain for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score that consists of 5 questions. It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much pain the subject has experienced during the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question. | 26 weeks after treatment compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment. | Safety and tolerability will be assessed at each clinic visit (Baseline, 2, 6, 12, 18 and 26 weeks). Standard questions was used, "Since your last clinical visit have you had any health problems?". | From baseline to 26 weeks after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per-Erik Melberg, MD | Kristinelundskliniken, Kristinelundsgatan 13, 411 37 Göteborg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Torsten Adalberth | Malmö | 211 36 | Sweden | |||
| Christian Akermark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Durolane 3 mL | Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation) |
| FG001 | Durolane 4.5 mL | Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation) |
| FG002 | Durolane 6 mL | Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Durolane 3 mL | Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation) |
| BG001 | Durolane 4.5 mL | Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change of Pain Over 26 Weeks (Change From Baseline) | The study aims to compare the change of pain for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score that consists of 5 questions. It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much pain the subject has experienced during the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question. | The primary population for all efficacy evaluations was the ITT population (all subjects randomized and treated with study product). No imputation of missing data was done. Analyses presented were based on observed cases. | Posted | Mean | Standard Deviation | units on a scale | 26 weeks after treatment compared to baseline |
|
Adverse events data were collected during 26 weeks.
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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 | Durolane 3 mL | Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary thrombosis | Vascular disorders | MedDRA 13.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | The related arthralgia events had a rapid onset and usually started within 1 day after injection of the study product and the duration was in general short. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Medical Affairs | Q-Med AB | +46 (0) 18 4749000 | reception.SEUPP@galderma.com |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| WOMAC Stiffness Score (Change From Baseline) | The study aims to compare the change of stiffness for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) stiffness score that consists of 2 questions. It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much stiffness the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question. | 26 weeks after treatment compared to baseline |
| WOMAC Physical Function Score (Change From Baseline) | The study aims to compare the physical function for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) physical function score that consists of 17 questions. It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to performing daily physical activities the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question. | 26 weeks after treatment compared to baseline |
| Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline) | The subject will assess his/her global status how the study knee affects them by using a 11-point numerical rating scale, Subject global assessment scale, from "very poor=0" to "excellent=10". | 26 weeks after treatment compared to baseline |
| Stockholm |
| 111 35 |
| Sweden |
| Johan Isacson | Upplands Vasby | 194 89 | Sweden |
| BG002 | Durolane 6 mL | Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Durolane 4.5 mL | WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml). |
| OG002 | Durolane 6 mL | WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml). |
|
|
| Secondary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment. | Safety and tolerability will be assessed at each clinic visit (Baseline, 2, 6, 12, 18 and 26 weeks). Standard questions was used, "Since your last clinical visit have you had any health problems?". | Posted | Number | participants | From baseline to 26 weeks after treatment |
|
|
|
| Secondary | WOMAC Stiffness Score (Change From Baseline) | The study aims to compare the change of stiffness for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) stiffness score that consists of 2 questions. It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much stiffness the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question. | Posted | Mean | Standard Deviation | units on a scale | 26 weeks after treatment compared to baseline |
|
|
|
| Secondary | WOMAC Physical Function Score (Change From Baseline) | The study aims to compare the physical function for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) physical function score that consists of 17 questions. It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to performing daily physical activities the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question. | Posted | Mean | Standard Deviation | units on a scale | 26 weeks after treatment compared to baseline |
|
|
|
| Secondary | Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline) | The subject will assess his/her global status how the study knee affects them by using a 11-point numerical rating scale, Subject global assessment scale, from "very poor=0" to "excellent=10". | Posted | Mean | Standard Deviation | units on a scale | 26 weeks after treatment compared to baseline |
|
|
|
| 0 |
| 23 |
| 8 |
| 23 |
| EG001 | Durolane 4.5 mL | Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation) | 2 | 23 | 12 | 23 |
| EG002 | Durolane 6 mL | Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation) | 1 | 22 | 14 | 22 |
| Headache and high fever | General disorders | MedDRA 13.1 |
|
| Rectal prolaps | Surgical and medical procedures | MedDRA 13.1 |
|
|
| Headache | Nervous system disorders | MedDRA 13.1 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 |
|
| Gastroenteritis | Infections and infestations | MedDRA 13.1 |
|
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| D012216 |
| Rheumatic Diseases |