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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04814719




Registration number
NCT04814719
Ethics application status
Date submitted
18/03/2021
Date registered
24/03/2021
Date last updated
8/04/2024

Titles & IDs
Public title
An Observational Follow-up Study to Evaluate Duration of Treatment Effect of Pentosan Polysulfate Sodium in Participants With Knee Osteoarthritis Pain
Scientific title
An Observational Follow-up Study to Investigate the Duration of Treatment Effect With Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain
Secondary ID [1] 0 0
PARA_OA_006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Pentosan Polysulphate Sodium
Treatment: Drugs - Placebo (Sodium Chloride Injection, 0.9%)

Pentosan Polysulfate Sodium - Pentosan Polysulfate Sodium (PPS) at Dose and frequency selected in Stage 1 of Parent Study for 6 weeks

Placebo - Placebo for 6 weeks


Treatment: Drugs: Pentosan Polysulphate Sodium
Subcutaneous Injection (100mg/ml)

Treatment: Drugs: Placebo (Sodium Chloride Injection, 0.9%)
Placebo to match PPS
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the duration of treatment effect of PPS in participants with OA pain
Timepoint [1] 0 0
From initial response time baseline in parent study up to 34 weeks
Secondary outcome [1] 0 0
To evaluate the duration of treatment effect of PPS in participants with OA pain
Timepoint [1] 0 0
Week 8, 16, 24, and 34
Secondary outcome [2] 0 0
To evaluate the efficacy of PPS treatment on knee pain in participants with knee OA pain
Timepoint [2] 0 0
Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
Secondary outcome [3] 0 0
WOMAC NRS 3.1 assessment of knee function in participants with knee OA pain
Timepoint [3] 0 0
Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
Secondary outcome [4] 0 0
WOMAC NRS 3.1 knee stiffness assessment in participants with knee OA
Timepoint [4] 0 0
Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
Secondary outcome [5] 0 0
Overall score WOMAC NRS 3.1in participants with knee OA
Timepoint [5] 0 0
Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
Secondary outcome [6] 0 0
To evaluate the effect of PPS on Patient Global Impression of Change (PGIC) in participants with knee OA pain
Timepoint [6] 0 0
Weeks 8, 16, 24 and 34
Secondary outcome [7] 0 0
Change from baseline of the parent study in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36)
Timepoint [7] 0 0
Baseline (parent study) pDay1, Weeks 8, 16, 24 and 34
Secondary outcome [8] 0 0
Change from baseline of the parent study in Work Productivity and Activity Impairment (WPAI) questionnaire.
Timepoint [8] 0 0
Baseline (parent study) pDay1, Weeks 8, 16, 24 and 34
Secondary outcome [9] 0 0
To evaluate the real-world use of pain medications/therapies, following a single course of PPS
Timepoint [9] 0 0
Baseline up to Week 34
Secondary outcome [10] 0 0
To Evaluate the safety and tolerability of PPS is participants with knee OA pain
Timepoint [10] 0 0
Baseline up to Week 34

Eligibility
Key inclusion criteria
* Participants who completed Day 168 of Study PARA_OA_002 (ie, did not discontinue/withdrew prematurely from the parent study).
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• An employee of the Sponsor, clinical research organisations or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/12/2025
Actual
Sample size
Target
Accrual to date
Final
133
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Paradigm Biopharmaceuticals USA (INC)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to measure the duration of treatment effect with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adult participants with knee osteoarthritis (OA) pain. The study duration will be up to 34 weeks.

Participants who completed pDay 162 of Study PARA_OA_002 (i.e. did not discontinue/withdraw prematurely from the parent study) will be invited to participate.
Trial website
https://clinicaltrials.gov/study/NCT04814719
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Schnitzer
Address 0 0
Northwestern University Feinberg School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04814719