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Osteoarthritis, KneePhase 1NCT03542838

Study of Resiniferatoxin for Knee Pain in Moderate to Severe Osteoarthritis

A Phase 1 study testing Resiniferatoxin and Saline in people with Osteoarthritis, Knee and Pain, Knee, run by Sorrento Therapeutics, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the safety 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, Pain, Knee
What is being tested?
Resiniferatoxin and Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
4 sitesUnited States
Study dates
12 Jul 2018to 11 Feb 2021
Phase
Phase 1
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

  • Age: 35 years to 85 years
  • Diagnosis of moderate to severe pain due to OA: Moderate to severe osteoarthritis, based on American College of Rheumatology (ACR) criteria
  • BMI < 45 kg/m2
  • Pain in the target knee has been treated with at least 2 analgesic agents, including at least one NSAID
  • Prior failure in at least two prior analgesic agents (at least one NSAID)
  • Willing to abstain from other intra-articular treatments of the knee or any knee surgery for at least 24 weeks after treatment
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  • Ability to comply with the study and give informed consent
  • If on an opioid medication, stable dose for at least 4 weeks prior to injection with no increase in dose leading up to study injection
  • If on NSAIDs, be on a stable analgesic regimen for at least 4 weeks prior to injection
  • If on pain regimens other than opioid medication or NSAIDs, be on a stable regimen for at least 30 days
  • Is in good general health and is considered to have a physical status that is American Society of Anesthesiologists (ASA) category ≤ 3
  • Able to comply with study procedures, including the recording of daily questionnaires

Who cannot join

  • Has evidence or history of a coagulopathy or hemostasis problem at Screening or Baseline (Day 1)
  • Treatment knee injections with corticosteroids within 30 days or hyaluronic acid within 3 months prior to the procedure
  • If on opioid analgesics, an upper limit of 30 mg/day of oral morphine sulfate, 20 mg/day of oxycodone, 30 mg/day of hydrocodone, or 300 mg/day of tramadol, or equivalent
  • Any of the following lab abnormalities within one week of the treatment day:
  • Platelet count <100,000 cells/mm3
  • Total neutrophil count <1500 cells/mm3
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  • Serum creatinine ≥ 1.5 x ULN
  • Alanine aminotransferase (ALT) > 3.0 x ULN
  • Aspartate aminotransferase (AST) > 3.0 x ULN
  • Alkaline phosphatase > 2.0 ULN
  • Bilirubin > 1.5 x ULN
  • INR > 1.5 x ULN
  • Temperature ≥ 100.4°F or other evidence of an infection
  • Concurrent use of opioids for indications other than knee pain
  • History of substance abuse
  • Has an allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin or radiographic contrast agents
  • Female subjects who are pregnant at Screening or are planning on becoming pregnant, or are currently breastfeeding
  • Subjects with any medical condition or comorbidities that could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments
  • Subjects who have participated in a clinical study of an investigational drug within 4 half-lives of Screening or are scheduled to receive and investigational agent while participating in this study
  • Sensory peripheral neuropathy that is CTCAE Grade 2 or higher at Screening
  • Arterial or venous thrombi, myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within 12 months prior to Screening
  • Evidence or history of any hemorrhage or bleeding event that is higher than CTCAE Grade 1 within 4 weeks prior to injection.
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C. Positive tests for HIV-1 or -2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies.
  • Concurrent medical or arthritic conditions that could interfere with evaluation of the index knee joint including fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies affecting the knee joint
  • Subjects with significant pain in other joints may be excluded at the discretion of the investigator
  • Subject has undergone arthroscopic or open surgery to the knee within 6 months of the planned injection day
  • Subject has undergone replacement surgery of the treatment knee
  • Presence of surgical hardware or other foreign bodies in the treatment knee

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Hermann Drive Surgical Hospital

    Houston, Texas, 77004

  • Snibbe Orthopedics

    Los Angeles, California, 90048

  • University of Miami/Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: Phase 1b Double-blind Study to Assess the Safety, Tolerability and Preliminary Efficacy of Intra-articular Administration of Resiniferatoxin Versus Placebo for the Treatment of Pain Due to Moderate to Severe Osteoarthritis of the Knee

This study evaluates the safety of resiniferatoxin in patients with moderate to severe knee pain due to osteoarthritis.

Read the detailed description

This study is to evaluate the safety of resiniferatoxin administered intra-articularly to subjects with moderate to severe knee pain due to osteoarthritis (OA). It is also to assess the preliminary efficacy of resiniferatoxin to relieve knee pain when walking.

Being tested
Resiniferatoxin, Saline
Medical subject headings
Osteoarthritis, Knee, Pain

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.

  • SalineDrug

    Also called Normal saline

    Saline is a normal physiological solution

Study groups in NCT03542838
Study groupRoleWhat they receive
ResiniferatoxinExperimentalResiniferatoxin is administered as a one-time dose, intra-articularly at a dose level of 5ug, 12.5ug, 20ug, 25ug, or 30ug.
Receives: Drug: Resiniferatoxin
SalinePlacebo comparatorSaline is administered as a one-time dose, intra-articularly.
Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety measurement

    Incidence and severity of adverse events

    Measured: baseline through week 52

Secondary outcomes (1)

  1. Improvement of knee pain when walking

    Improvement in pain score versus baseline using the WOMAC Osteoarthritis Index question A1 (pain on walking, 11-point numerical rating scale)

    Measured: baseline through week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2018
  2. Study start12 Jul 2018
  3. Primary completion13 Apr 2020
  4. Study completion11 Feb 2021

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03542838
Sponsor's protocol ID
PTVA OA-001
Status last verified
Mar 2021
First submitted
7 May 2018
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Resiniferatoxin and Saline in people with Osteoarthritis, Knee and Pain, Knee, run by Sorrento Therapeutics, Inc. at 4 sites in United States.

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 12 inclusion and 28 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: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety measurement (time frame: baseline through week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03542838.

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 1 Apr 2021.

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