Osteoarthritis, KneePhase 3NCT04044742
A Phase 3 Study to Evaluate the Efficacy and Safety of Resiniferatoxin for Pain Due to Osteoarthritis of the Knee
A Phase 3 study testing Resiniferatoxin in people with Osteoarthritis, Knee and Knee Pain Chronic, run by Sorrento Therapeutics, Inc..
Trial summary
This study evaluates the efficacy and safety of intra-articular injection of resiniferatoxin in patients with moderate to severe knee pain due to osteoarthritis. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee, Knee Pain Chronic
- What is being tested?
- Resiniferatoxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Mar 2023
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 35 to 85 years of age (inclusive).
- Diagnosis of moderate to severe pain in the index knee due to OA.
- Pain in the non-index knee is less than pain in the index knee.
- Body mass index ≤40 kg/m².
- Experienced treatment failure with at least 2 prior categories of therapies.
- Able to understand and complete study-related forms and communicate with the Investigator and/or site staff.
Who cannot join
- Evidence or history of a serious coagulopathy or hemostasis problem, such as inherited bleeding disorders or thrombocytopenia.
- History of or current condition of poorly controlled hypertension, QTc prolongation, history of risk factors for Torsades de Pointes, or family history of long QT syndrome; or is using concomitant medications that prolong the QT interval.
- Received index knee injections with corticosteroids within 30 days, or hyaluronic acid within 3 months, or platelet-rich plasma within 6 months prior to the injection day.
- Pre-existing osteonecrosis, subchondral insufficiency fracture, severe bone on bone OA, or knee pain attributable to disease other than OA.
- Instability or misalignment in the index knee.
- Concurrent use of opioids or indications other than knee pain.
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- History within the past 2 years of substance abuse, including alcohol.
- Allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin, acetaminophen, tramadol, or radiographic contrast agents.
- Female participants who are pregnant, planning on becoming pregnant, or currently breastfeeding.
- Any medical condition or comorbidities that, in the Investigator's opinion, could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments.
- Sensory peripheral neuropathy that is of moderate severity or higher.
- Arterial or venous thrombi (including stroke), myocardial infarction, hospital admission for unstable angina, cardiac angioplasty, or stenting within the past 12 months.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or hepatitis C. Participants with these viral infections who are receiving or have received antiviral treatment and have a viral load that is undetectable are eligible.
- Concurrent medical or arthritic conditions that could interfere with the evaluation of the index knee joint including chondromalacia patellae, metabolic diseases, gout/pseudogout, hemochromatosis, acromegaly, fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies affecting the knee joint.
- Undergone arthroscopic surgery of the index knee within 6 months of the injection day, or open surgery to the index knee within 24 months of the injection day.
- Undergone replacement surgery of the index knee.
- Presence of surgical hardware or other foreign bodies in the index knee.
About this study
Official title: A Phase 3 Placebo-controlled Study to Evaluate the Efficacy and Safety of Intra-articular Administration of Resiniferatoxin Versus Placebo for the Treatment of Moderate to Severe Pain Due to Osteoarthritis of the Knee
This study evaluates the efficacy and safety of intra-articular injection of resiniferatoxin in patients with moderate to severe knee pain due to osteoarthritis.
Read the detailed description
This study is to evaluate the analgesic efficacy and safety of resiniferatoxin administered intra-articularly to subjects with moderate to severe knee pain due to osteoarthritis (OA).
- Conditions
- Osteoarthritis, Knee, Knee Pain Chronic
- Being tested
- Resiniferatoxin, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResiniferatoxinDrug
Also called RTX
Receiving Resiniferatoxin injection
PlaceboDrug
Also called Diluent
Receiving Placebo injection
| Study group | Role | What they receive |
|---|---|---|
| Resiniferatoxin | Experimental | 12.5 ug of Resiniferatoxin in 5 mL volume is administered as a one-time dose, intra-articularly Receives: Drug: Resiniferatoxin |
| Placebo | Placebo comparator | Placebo formulation in 5 mL volume administered intra-articularly Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in index knee pain with walking
Change in the weekly mean of Average Daily Pain (ADP) scores in the index knee, using the 10-point Numerical Pain Rating Scale (NPRS)
Measured: Baseline through Week 12
Secondary outcomes (14)
Area under the curve (AUC) change in average pain in the index knee
AUC calculated on change in the average pain in the index knee over the previous 24 hours, using the NPRS (0-10)
Measured: Baseline through Week 12
Change in index knee pain with walking
Change in the weekly mean of ADP scores in the index knee, using the NPRS (0-10)
Measured: Baseline through Week 26
AUC change in average pain in the index knee
AUC calculated on change in the average pain in the index knee over the previous 24 hours, using the NPRS (0-10)
Measured: Baseline through Week 26
Duration of effect of a single injection in the index knee
Time to return to baseline pain score, based on weekly average NPRS (0-10) scores
Measured: Baseline through return to Baseline
Change in index knee pain, stiffness, and physical function
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score
Measured: Baseline through Week 12, Week 26, and Week 52
Change in the average pain in the index knee
Change in the WOMAC A pain subscale
Measured: Baseline through Week 12, Week 26, and Week 52
Change in the average stiffness in the index knee
Change in the WOMAC B function subscale
Measured: Baseline through Week 12, Week 26, and Week 52
Change in the average function in the index knee
Change in the WOMAC C stiffness subscale
Measured: Baseline through Week 12, Week 26, and Week 52
Change in index knee pain with walking
Change in the weekly mean of ADP scores in the index knee, using the NPRS (0-10)
Measured: Baseline through Week 52
AUC change in average pain in the index knee
AUC calculated on change in the average pain in the index knee over the previous 24 hours, using the NPRS (0-10)
Measured: Baseline through Week 52
Change in quality of life (QOL) - SF-36 Health Survey
Change in QOL as measured by the SF-36 Health Survey
Measured: Baseline through Week 12, Week 26, and Week 52
Change in quality of sleep
Change in quality of sleep as measured by the MOS Sleep Scale
Measured: Baseline through Week 12, Week 26, and Week 52
Patient Global Impression of Change
Rating of change in index knee pain using the PGIC scale
Measured: At Week 12, Week 26, and Week 52
Change in QOL - EQ-5D-5L
Change in QOL as measured by the EQ-5D-5L
Measured: Baseline through Week 12, Week 26, and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study startDec 2020 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (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
- NCT04044742
- Sponsor's protocol ID
- STI-RTX-3001
- Status last verified
- Nov 2021
- First submitted
- 2 Aug 2019
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Placebo-controlled Study to Evaluate the Efficacy and Safety of Intra-articular Administration of Resiniferatoxin Versus Placebo for the Treatment of Moderate to Severe Pain Due to Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT04044742
- Acronym / sponsor ID
- STI-RTX-3001
- Conditions
- Osteoarthritis, Knee, Knee Pain Chronic
- 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
- Dec 2020 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 5 Aug 2019 (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.
This study evaluates the efficacy and safety of intra-articular injection of resiniferatoxin in patients with moderate to severe knee pain due to osteoarthritis.
Detailed description
This study is to evaluate the analgesic efficacy and safety of resiniferatoxin administered intra-articularly to subjects with moderate to severe knee pain due to osteoarthritis (OA).
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 is administered as a one-time dose, intra-articularly |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo formulation in 5 mL volume administered intra-articularly |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female 35 to 85 years of age (inclusive).
- Diagnosis of moderate to severe pain in the index knee due to OA.
- Pain in the non-index knee is less than pain in the index knee.
- Body mass index ≤40 kg/m².
- Experienced treatment failure with at least 2 prior categories of therapies.
Key exclusion criteria (17 listed)
- Evidence or history of a serious coagulopathy or hemostasis problem, such as inherited bleeding disorders or thrombocytopenia.
- History of or current condition of poorly controlled hypertension, QTc prolongation, history of risk factors for Torsades de Pointes, or family history of long QT syndrome; or is using concomitant medications that prolong the QT interval.
- Received index knee injections with corticosteroids within 30 days, or hyaluronic acid within 3 months, or platelet-rich plasma within 6 months prior to the injection day.
- Pre-existing osteonecrosis, subchondral insufficiency fracture, severe bone on bone OA, or knee pain attributable to disease other than OA.
- Instability or misalignment in 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: RTXReceiving Resiniferatoxin injection | Drug | Resiniferatoxin |
| PlaceboAlso: DiluentReceiving Placebo injection | Drug | Placebo |
Primary outcome
Change in index knee pain with walking
Time frame: Baseline through Week 12
Change in the weekly mean of Average Daily Pain (ADP) scores in the index knee, using the 10-point Numerical Pain Rating Scale (NPRS)
14 secondary outcomes
Area under the curve (AUC) change in average pain in the index knee
Time frame: Baseline through Week 12
Change in index knee pain with walking
Time frame: Baseline through Week 26
AUC change in average pain in the index knee
Time frame: Baseline through Week 26
Duration of effect of a single injection in the index knee
Time frame: Baseline through return to Baseline
Change in index knee pain, stiffness, and physical function
Time frame: Baseline through Week 12, Week 26, and Week 52
Change in the average pain in the index knee
Time frame: Baseline through Week 12, Week 26, and Week 52
Change in the average stiffness in the index knee
Time frame: Baseline through Week 12, Week 26, and Week 52
Change in the average function in the index knee
Time frame: Baseline through Week 12, Week 26, and Week 52
Change in index knee pain with walking
Time frame: Baseline through Week 52
AUC change in average pain in the index knee
Time frame: Baseline through Week 52
Change in quality of life (QOL) - SF-36 Health Survey
Time frame: Baseline through Week 12, Week 26, and Week 52
Change in quality of sleep
Time frame: Baseline through Week 12, Week 26, and Week 52
Patient Global Impression of Change
Time frame: At Week 12, Week 26, and Week 52
Change in QOL - EQ-5D-5L
Time frame: Baseline through Week 12, Week 26, and Week 52
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 Knee Pain Chronic, 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 6 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 index knee pain with walking (time frame: Baseline through 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.