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Osteoarthritis of the KneePhase 1/2NCT01645709

Safety, Tolerability, and Efficacy of IA Verapamil in the Treatment of Joint Pain in Subjects With Osteoarthritis of the Knee

A Phase 1/2 study testing Verapamil in people with Osteoarthritis of the Knee, run by Calosyn Pharma, Inc..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of Intra-Articular (IA) verapamil in the treatment of joint pain in patients with knee osteoarthritis (OA). Read more about this study

Who is it for?
Ages 35 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Osteoarthritis of the Knee
What is being tested?
Verapamil
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
No sites listed yet
Study dates
Apr 2012to Feb 2013
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following inclusion criteria to participate in the study:
  • Be 35-75 years of age and in good general medical and psychological health.
  • Be able to speak, read, write, and understand English, understand the consent form, complete study-related procedures, and communicate with the study staff.
  • Have OA of at least 1 knee (target knee) for at least 6 months and meet all the following criteria:
  • OA documented by standing X-rays anterior-posterior patella-femoral view taken within 1 month of screening visit indicating Kellgren-Lawrence Grade 2 to early-stage Grade 4 radiographic stage of the knee;
  • Have pain associated with OA of the target knee for at least 25 of the last 30 days; c. Meet the American College of Rheumatology clinical classification criteria, defined as having pain in the target knee and at least 3 of the following 6 items:
Show all 19Show fewer
  • Age > 50;
  • Morning stiffness <30 minutes;
  • Crepitus on active motion;
  • Bony tenderness;
  • Bony enlargement;
  • No palpable warmth of synovium.
  • Target knee does not have any type of orthopedic and/or prosthetic device.
  • Based on standard physical examination of the target knee, does not have any neurovascular deficits, any skin abnormalities, any meniscal abnormalities, or any ligament instability.
  • At treatment visit 2 prior to randomization, have a score of at least 20 on the WOMAC pain subscale (questions 1-5) for the target knee and an in-clinic average pain intensity score of at least 4/10 on the 0-10 NRS for the 24-hour recall.
  • Be willing to maintain any present stable treatment modalities (e.g., acupuncture or physical therapy) and be willing to refrain from initiating any new treatment modalities.
  • Be willing to stop taking nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids for the duration of the study.
  • If female of child-bearing potential (ie, not medically or surgically sterilized or not post-menopausal more than 1 year) or fertile male with sexual partner of childbearing potential, be willing to use adequate and reliable contraception throughout the study (eg, abstinence or barrier with additional spermicidal foam or jelly, or the use of intrauterine device or hormonal contraception by female subjects and partners of male subjects).
  • Not be enrolled in any other clinical trial and not have used any investigational drug within 1 month.

Who cannot join

  • Subjects who meet any of the following criteria will not be eligible to participate:
  • Have a Kellgren-Lawrence Grade 1 radiographic stage of the knee or have Kellgren-Lawrence Grade 4 radiographic end stage of the knee with bone on bone, ie, less than 2 mm joint space.
  • Be a candidate for knee replacement within next 6 months.
  • Have a body mass index > 35 kg/m2.
  • Have a Hospital Anxiety and Depression Scale score >12 on either subscale or have an established history of major depressive disorder not controlled with medication.
  • Have, in the Investigator's opinion, clinically significant abnormalities in clinical laboratory tests (hematology, clinical labs, urinalysis).
Show all 20Show fewer
  • Have a positive urine drug test for illegal drug substances at screening.
  • Have, in the Investigator's opinion, clinically significant abnormalities in electrocardiogram readings
  • If a female of childbearing potential, have a positive pregnancy test at screening.
  • Have significant pain outside the target knee, including significant hip or back pain (bilateral knee OA will be allowed as long as target knee pain can be distinguished from contralateral knee pain and contralateral knee does not require treatment).
  • Have pain affecting the target knee that is due to any etiology other than OA.
  • Have documented history of inflammatory arthritis, including rheumatoid arthritis.
  • Have a meniscal tear in the target knee.
  • Have had viscosupplementation with hyaluronic acid products within 6 months prior to screening.
  • Have failed to respond to prior treatment with viscosupplementation with hyaluronic acid products.
  • Have had IA corticosteroid injections within 12 weeks or intramuscular or oral steroids within 4 weeks prior to screening.
  • Have had surgery of the target knee within 6 months prior to screening.
  • Have used opioids 4 or more days per week during in the past month prior to screening.
  • Are allergic to, or intolerant of, acetaminophen.
  • Have used verapamil within the past 4 weeks or are allergic or intolerant to verapamil.

About this study

Official title: CS-201: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Intra-Articular Verapamil in the Treatment of JoinT Pain in Subjects With Osteoarthritis of the Knee

This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of Intra-Articular (IA) verapamil in the treatment of joint pain in patients with knee osteoarthritis (OA). Subjects will discontinue all analgesic medications for the entire duration of the study, except for acetaminophen (taken on an as needed basis at no more than 2 g/day). At visit 2, subjects who meet all entry criteria will be randomized to receive a single injection of IA verapamil or IA placebo at a ratio of 1:1. Treatments will be given with fluoroscopy or ultrasound to confirm needle placement. Subjects will be monitored for blood pressure and heart rate (sitting and standing) for at least 1 hour post-injection. Subjects will be evaluated at weeks 1, 2, 3, 4, 6, 8, and 12 after treatment.

Being tested
Verapamil, 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.

  • VerapamilDrug

  • PlaceboDrug

Study groups in NCT01645709
Study groupRoleWhat they receive
VerapamilExperimentalSubjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Receives: Drug: Verapamil
PlaceboPlacebo comparatorSubjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Receives: Drug: Placebo

What is being measured

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

  1. Compare Efficacy of Verapmil vs Placebo at Week 4

    To compare the efficacy of IA verapamil versus IA placebo for pain relief using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 4.

    Measured: 4 weeks

Secondary outcomes (8)

  1. Compare Efficacy of Verapamil to Placebo Compared to Baseline

    To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:

    • WOMAC total and subscale scores for pain, function, and stiffness at each visit

    Measured: 13 weeks

  2. Compare Efficacy of Verapamil to Placebo Compared to Baseline

    To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:

    • WOMAC pain subscale as measured from 2 to 12 weeks post-treatment using an AUC approach

    Measured: 13 weeks

  3. Compare Efficacy of Verapamil to Placebo Compared to Baseline

    To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:

    • In-clinic 24-hour recall pain intensity using the 0-10 numerical rating scale (NRS) at each visit

    Measured: 13 weeks

  4. Compare Efficacy of Verapamil to Placebo Compared to Baseline

    To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:

    • Difference in the current in-clinic pain intensity using the 0-10 NRS before and after exercise at each visit

    Measured: 13 weeks

  5. Compare Efficacy of Verapamil to Placebo Compared to Baseline

    To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:

    • Response rate

    Measured: 13 weeks

  6. Compare Efficacy of Verapamil to Placebo Compared to Baseline

    To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:

    • Patient Global Impression of Change (PGIC)

    Measured: 13 weeks

  7. Compare Efficacy of Verapamil to Placebo Compared to Baseline

    To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:

    • Rescue medication use

    Measured: 13 weeks

  8. Number of Subjects With Adverse Events

    Compare the safety of IA verapamil versus IA placebo using adverse events (AEs) as a comparator

    Measured: 13 weeks

Timeline

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

  1. First posted20 Jul 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionFeb 2013

Why it stopped: Sponsor decision to terminate study

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01645709
Sponsor's protocol ID
CS-201
Status last verified
Aug 2014
First submitted
17 Jul 2012
Last updated
5 Sep 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Verapamil in people with Osteoarthritis of the Knee, run by Calosyn Pharma, 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 19 inclusion and 20 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: stopped early, as of the sponsor's last update on 5 Sep 2014. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Compare Efficacy of Verapmil vs Placebo at Week 4 (time frame: 4 weeks). 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 NCT01645709.

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 5 Sep 2014.

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