Trial Outcomes & Findings for Different Volumes of Durolane in Knee OA (NCT NCT01265459)

NCT ID: NCT01265459

Last Updated: 2022-09-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 68 participants
• Primary outcome timeframe: 26 weeks after treatment compared to baseline
• Results posted on: 2022-09-22

Participant Flow

Participant milestones

Measure	Durolane 3 mL Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)	Durolane 4.5 mL Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)	Durolane 6 mL Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
Overall Study STARTED	23	23	22
Overall Study COMPLETED	23	23	20
Overall Study NOT COMPLETED	0	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Different Volumes of Durolane in Knee OA

Baseline characteristics by cohort

Measure	Durolane 3 mL n=23 Participants Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)	Durolane 4.5 mL n=23 Participants Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)	Durolane 6 mL n=22 Participants Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)	Total n=68 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=93 Participants	23 Participants n=4 Participants	22 Participants n=27 Participants	68 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Continuous	62.3 years STANDARD_DEVIATION 9.8 • n=93 Participants	64.1 years STANDARD_DEVIATION 8.0 • n=4 Participants	62.8 years STANDARD_DEVIATION 7.3 • n=27 Participants	63.1 years STANDARD_DEVIATION 8.4 • n=483 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	11 Participants n=4 Participants	10 Participants n=27 Participants	32 Participants n=483 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	12 Participants n=4 Participants	12 Participants n=27 Participants	36 Participants n=483 Participants
Region of Enrollment Sweden	23 participants n=93 Participants	23 participants n=4 Participants	22 participants n=27 Participants	68 participants n=483 Participants

PRIMARY outcome

Timeframe: 26 weeks after treatment compared to baseline

Population: 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.

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.

Outcome measures

Measure	Durolane 3 mL n=23 Participants WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).	Durolane 4.5 mL n=23 Participants WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).	Durolane 6 mL n=20 Participants WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
Change of Pain Over 26 Weeks (Change From Baseline)	-4.13 units on a scale Standard Deviation 4.39	-4.00 units on a scale Standard Deviation 3.74	-4.90 units on a scale Standard Deviation 5.06

SECONDARY outcome

Timeframe: 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?".

Outcome measures

Measure	Durolane 3 mL n=23 Participants WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).	Durolane 4.5 mL n=23 Participants WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).	Durolane 6 mL n=20 Participants WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment.	8 participants	12 participants	14 participants

SECONDARY outcome

Timeframe: 26 weeks after treatment compared to 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.

Outcome measures

Measure	Durolane 3 mL n=23 Participants WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).	Durolane 4.5 mL n=23 Participants WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).	Durolane 6 mL n=20 Participants WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
WOMAC Stiffness Score (Change From Baseline)	-1.30 units on a scale Standard Deviation 2.27	-1.39 units on a scale Standard Deviation 1.85	-1.15 units on a scale Standard Deviation 1.90

SECONDARY outcome

Timeframe: 26 weeks after treatment compared to 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.

Outcome measures

Measure	Durolane 3 mL n=23 Participants WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).	Durolane 4.5 mL n=23 Participants WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).	Durolane 6 mL n=20 Participants WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
WOMAC Physical Function Score (Change From Baseline)	-11.14 units on a scale Standard Deviation 13.98	-13.13 units on a scale Standard Deviation 11.93	-12.32 units on a scale Standard Deviation 14.86

SECONDARY outcome

Timeframe: 26 weeks after treatment compared to 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".

Outcome measures

Measure	Durolane 3 mL n=23 Participants WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).	Durolane 4.5 mL n=23 Participants WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).	Durolane 6 mL n=20 Participants WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline)	1.43 units on a scale Standard Deviation 2.64	1.39 units on a scale Standard Deviation 2.44	1.70 units on a scale Standard Deviation 3.69

Adverse Events

Durolane 3 mL

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Durolane 4.5 mL

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Durolane 6 mL

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Durolane 3 mL n=23 participants at risk Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)	Durolane 4.5 mL n=23 participants at risk Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)	Durolane 6 mL n=22 participants at risk Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
Vascular disorders Pulmonary thrombosis	0.00% 0/23 • Adverse events data were collected during 26 weeks.	4.3% 1/23 • Number of events 1 • Adverse events data were collected during 26 weeks.	0.00% 0/22 • Adverse events data were collected during 26 weeks.
General disorders Headache and high fever	0.00% 0/23 • Adverse events data were collected during 26 weeks.	4.3% 1/23 • Number of events 1 • Adverse events data were collected during 26 weeks.	0.00% 0/22 • Adverse events data were collected during 26 weeks.
Surgical and medical procedures Rectal prolaps	0.00% 0/23 • Adverse events data were collected during 26 weeks.	0.00% 0/23 • Adverse events data were collected during 26 weeks.	4.5% 1/22 • Number of events 1 • Adverse events data were collected during 26 weeks.

Other adverse events

Measure	Durolane 3 mL n=23 participants at risk Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)	Durolane 4.5 mL n=23 participants at risk Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)	Durolane 6 mL n=22 participants at risk Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
Musculoskeletal and connective tissue disorders Arthralgia	21.7% 5/23 • Number of events 6 • Adverse events data were collected during 26 weeks.	34.8% 8/23 • Number of events 8 • Adverse events data were collected during 26 weeks.	40.9% 9/22 • Number of events 9 • Adverse events data were collected during 26 weeks.
Nervous system disorders Headache	0.00% 0/23 • Adverse events data were collected during 26 weeks.	17.4% 4/23 • Number of events 7 • Adverse events data were collected during 26 weeks.	31.8% 7/22 • Number of events 10 • Adverse events data were collected during 26 weeks.
Musculoskeletal and connective tissue disorders Back pain	8.7% 2/23 • Number of events 2 • Adverse events data were collected during 26 weeks.	8.7% 2/23 • Number of events 2 • Adverse events data were collected during 26 weeks.	22.7% 5/22 • Number of events 5 • Adverse events data were collected during 26 weeks.
Infections and infestations Nasopharyngitis	8.7% 2/23 • Number of events 2 • Adverse events data were collected during 26 weeks.	17.4% 4/23 • Number of events 4 • Adverse events data were collected during 26 weeks.	13.6% 3/22 • Number of events 3 • Adverse events data were collected during 26 weeks.
Infections and infestations Gastroenteritis	4.3% 1/23 • Number of events 1 • Adverse events data were collected during 26 weeks.	0.00% 0/23 • Adverse events data were collected during 26 weeks.	13.6% 3/22 • Number of events 3 • Adverse events data were collected during 26 weeks.

Additional Information

Head of Medical Affairs

Q-Med AB

Phone: +46 (0) 18 4749000

Email: reception.SEUPP@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60