Osteoarthritis, KneePhase 3NCT04386980
Study to Evaluate Resiniferatoxin in Patients With Knee Osteoarthritis Whose Total Knee Replacement Surgery is Delayed
A Phase 3 study testing Resiniferatoxin in people with Osteoarthritis, Knee and Osteo Arthritis Knee, run by Sorrento Therapeutics, Inc..
Trial summary
Efficacy and safety study of resiniferatoxin versus placebo to manage pain in patients with knee osteoarthritis whose TKR surgery is delayed Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteo Arthritis Knee, Knee Pain Chronic
- What is being tested?
- Resiniferatoxin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give informed consent and comply with the study
- Diagnosis of osteoarthritis (OA) in the index knee
- Combined WOMAC A (pain) and C (function) subscale score of ≥ 23 at screening, using the WOMAC 5-point Likert scale
- Eligible for total knee replacement (TKR) surgery but unable to schedule surgery or undergo scheduled surgery
- In good general health; American Society of Anesthesiologists (ASA) physical status category ≤3
- Willing to use contraception for at least 30 days after receiving the study drug
- Able to understand and complete study-related forms and adequately communicate with the Investigator and site staff
Who cannot join
- Pre-existing osteonecrosis, subchondral insufficiency fracture, or knee pain attributable to disease other than OA which may confound the ability to assess response to treatment
- Concurrent medical or arthritic conditions that could interfere with evaluation of the index knee joint including, metabolic diseases, gout/pseudogout, hemochromatosis, acromegaly, fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies affecting the knee joint
- Participants with significant pain in the back or other joints (ex. hip pain) which may confound discrimination of pain assessment in index knee, as judged by the Investigator
- Undergone arthroscopic surgery of the index knee within 6 months of study drug administration, or open surgery to the index knee within 24 months of study drug administration
- Undergone replacement surgery of the index knee
- Presence of surgical hardware or other foreign bodies in the index knee
Show all 17Show fewer
- Index knee injections with corticosteroids within 30 days, or hyaluronic acid within 3 months, or platelet-rich plasma within 6 months prior to study drug administration.
- Concurrent use of opioids for indications other than knee pain
- Arterial or venous thrombi (including stroke), myocardial infarction, hospital admission for unstable angina, cardiac angioplasty, or stenting within 12 months prior to Screening.
- Sensory peripheral neuropathy in the distal aspect of the target limb that is of moderate severity or higher at Screening
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or hepatitis C; positive tests for HIV-1 or -2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies
- Specified laboratory abnormalities within 1 week of study drug administration
- History within the past 2 years of substance abuse, including alcohol
- Allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin, acetaminophen, tramadol, radiographic contrast agents, or any of the agents to be used for sedation, anesthesia or nerve block on the day of study drug administration
- Female participants who are pregnant, planning on becoming pregnant within 30 days of receiving study drug, or are breastfeeding at Screening
- Any medical condition or medical comorbidities that, in the Investigator's opinion, could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments
- Participated in a clinical study of an investigational drug within 4 half-lives of Screening or are scheduled to receive an investigational agent (therapy or device) while participating in this study
About this study
Official title: A Phase 3, Randomized, Multi-center, Blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intra-articular Resiniferatoxin Versus Placebo to Manage Pain in Patients With Osteoarthritis of the Knee Whose Total Knee Replacement Surgery is Delayed
Efficacy and safety study of resiniferatoxin versus placebo to manage pain in patients with knee osteoarthritis whose TKR surgery is delayed
Read the detailed description
This study evaluates the efficacy and safety of intra-articular resiniferatoxin (RTX) versus placebo to manage pain in patients with osteoarthritis of the knee whose Total Knee Replacement surgery is delayed.
- Being tested
- Resiniferatoxin, Placebo
- Keywords
- osteoarthritis, knee pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResiniferatoxinDrug
Also called RTX
Resiniferatoxin is a compound purified from natural sources.
PlaceboDrug
Diluent in normal saline
| Study group | Role | What they receive |
|---|---|---|
| Resiniferatoxin | Experimental | 12.5 ug of Resiniferatoxin in 5 mL volume administered once intra-articularly Receives: Drug: Resiniferatoxin |
| Placebo | Placebo comparator | 5 mL of diluent in normal saline administered once intra-articularly Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC pain and function subscales combined score
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 3.1 numerical rating scale (NRS) [0-10 scale] Pain and Function combined score. The combined score ranges from 0 to 220; a higher score indicates greater severity of disease.
Measured: Baseline to Week 12
Secondary outcomes (4)
Safety of RTX: Incidence and severity of adverse events
Incidence and severity of adverse events
Measured: Baseline through Week 12
Change in analgesic usage
Change in analgesic medication usage as reported by subjects
Measured: Baseline to Week 4, Week 8, Week 12
Change in WOMAC pain and function subscales combined score
Change in the WOMAC 3.1 NRS [0-10 scale] Pain and Function combined score. The combined score ranges from 0 to 220; a higher score indicates greater severity of disease.
Measured: Baseline to Week 4, Week 8
Patient Global Impression of Change (PGIC) in index knee pain
Rating of change in index knee pain using the 7-point PGIC scale where 1 = very much improved and 7 = very much worsened.
Measured: Baseline to Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study startApr 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: To be replaced by a different protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monica Luchi, MD, Study director, Sorrento Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386980
- Sponsor's protocol ID
- STI-RTX-3004
- Status last verified
- Nov 2021
- First submitted
- 8 May 2020
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Multi-center, Blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intra-articular Resiniferatoxin Versus Placebo to Manage Pain in Patients With Osteoarthritis of the Knee Whose Total Knee Replacement Surgery is Delayed
- ClinicalTrials.gov ID
- NCT04386980
- Acronym / sponsor ID
- STI-RTX-3004
- Keywords
- osteoarthritis, knee pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: To be replaced by a different protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy and safety study of resiniferatoxin versus placebo to manage pain in patients with knee osteoarthritis whose TKR surgery is delayed
Detailed description
This study evaluates the efficacy and safety of intra-articular resiniferatoxin (RTX) versus placebo to manage pain in patients with osteoarthritis of the knee whose Total Knee Replacement surgery is delayed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resiniferatoxin | Experimental | Drug: Resiniferatoxin12.5 ug of Resiniferatoxin in 5 mL volume administered once intra-articularly |
| Placebo | Placebo comparator | Drug: Placebo5 mL of diluent in normal saline administered once intra-articularly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to give informed consent and comply with the study
- Diagnosis of osteoarthritis (OA) in the index knee
- Combined WOMAC A (pain) and C (function) subscale score of ≥ 23 at screening, using the WOMAC 5-point Likert scale
- Eligible for total knee replacement (TKR) surgery but unable to schedule surgery or undergo scheduled surgery
- In good general health; American Society of Anesthesiologists (ASA) physical status category ≤3
Key exclusion criteria (17 listed)
- Pre-existing osteonecrosis, subchondral insufficiency fracture, or knee pain attributable to disease other than OA which may confound the ability to assess response to treatment
- Concurrent medical or arthritic conditions that could interfere with evaluation of the index knee joint including, metabolic diseases, gout/pseudogout, hemochromatosis, acromegaly, fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies affecting the knee joint
- Participants with significant pain in the back or other joints (ex. hip pain) which may confound discrimination of pain assessment in index knee, as judged by the Investigator
- Undergone arthroscopic surgery of the index knee within 6 months of study drug administration, or open surgery to the index knee within 24 months of study drug administration
- Undergone replacement surgery of the index knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResiniferatoxinAlso: RTXResiniferatoxin is a compound purified from natural sources. | Drug | Resiniferatoxin |
| PlaceboDiluent in normal saline | Drug | Placebo |
Primary outcome
Change in WOMAC pain and function subscales combined score
Time frame: Baseline to Week 12
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 3.1 numerical rating scale (NRS) [0-10 scale] Pain and Function combined score. The combined score ranges from 0 to 220; a higher score indicates greater severity of disease.
4 secondary outcomes
Safety of RTX: Incidence and severity of adverse events
Time frame: Baseline through Week 12
Change in analgesic usage
Time frame: Baseline to Week 4, Week 8, Week 12
Change in WOMAC pain and function subscales combined score
Time frame: Baseline to Week 4, Week 8
Patient Global Impression of Change (PGIC) in index knee pain
Time frame: Baseline to Week 4, Week 8, Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Luchi, MD study director
Sorrento Therapeutics, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Resiniferatoxin in people with Osteoarthritis, Knee and Osteo Arthritis Knee, run by Sorrento Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in WOMAC pain and function subscales combined score (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.