AzTrials
AzTrials

Pain Associated With Osteoarthritis of the KneePhase 3NCT03081806

A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis Knee Pain

A Phase 3 study testing X0002 in people with Pain Associated With Osteoarthritis of the Knee, run by Techfields Pharma Co. Ltd at 33 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

This is a Phase 3, Multicenter, 22-Week, double-blind and 30-Week open label Study to Evaluate the Efficacy and Safety of X0002 Spray in relief of pain of subjects with Osteoarthritis of the Knee. Read more about this study

Who is it for?
Ages 35 to 85 years
What is being tested?
X0002
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
399 participants
Where
33 sitesUnited States
Study dates
24 Sep 2021to 10 Jan 2024
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

  • Ability to read and provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and applicable regulations, before completing any study related procedures.
  • An understanding, ability, and willingness to fully comply with study procedures and restrictions.
  • Subject must be a male or female between 35 and 85 years of age, inclusive.
  • Female subjects must either not be of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or be willing to Practice at least 1 of the following medically acceptable methods of birth control.
  • Subject must have a body mass index (BMI) between 18.5 and 45 kg/m2, inclusive.
  • Must have a history of clinically symptomatic OA of the knee for ≥6 months.
Show all 20Show fewer
  • Must meet the American College of Rheumatology clinical classification criteria for knee OA. These criteria include the presence of knee pain in addition to at least 3 of the following 6 items:
  • age of ≥50 years
  • stiffness lasting <30 minutes
  • crepitus on knee motion
  • Bony Tenderness
  • Bony Enlargement
  • No palpable warmth
  • A subject must have a Kellgren Lawrence Grade of 2,3 or 4 as determined by a central radiologist at the first screening visit. .
  • Subject must have had knee pain while standing, walking, and/or in motion for at least 14 days during the month prior to Screening.
  • Subject must have a knee pain score ≥4 and <9 on 0-10 pain intensity NRS (without analgesic medication) on at least 7 of the 10 days prior to randomization.
  • Subject must be willing to discontinue any NSAIDs or other analgesic (eg, aspirin, acetaminophen) or potentially confounding concomitant treatments (eg, physiotherapy, acupuncture) starting on the first screening visit until completing participation in the study. (The use of ≤325 mg acetylsalicylic acid per day as cardiac prophylaxis is permitted.) The subject will be allowed to take rescue medication (acetaminophen) for pain during the study except during the 24 hours prior to the Second Screening Visit, Baseline (Day1), Week 2, Week 4, Week 8, Week 12, Week 22, Week 32, Week 42, and Week 52/EOS.
  • Subject must be willing to discontinue applying any topical preparations containing Vitamin A acids (including all trans retinoic acid (tretinoin), 13 cis retinoic acid [isotretinoin], 9 cis retinoic acid [alitretinoin], vitamin A [retinol], retinal, and their derivatives) to the lower limbs starting on the first screening visit until completing participation in the study. (Topical preparations containing Vitamin A acids or retinol may be applied to areas of the skin above the waist, but should not be applied to areas of the skin exposed to study medication.)
  • Subject must be willing to avoid unaccustomed physical activity (eg, starting a new weight lifting routine) for the duration of the study starting on the first screening visit.
  • With the exception of OA of the knee subjects with medical history must be stable as determined by the investigator.

Who cannot join

  • Has worker's compensation injuries affecting the knee or back.
  • Has a history of or is currently in litigation regarding joint injuries.
  • Has secondary OA of the target knee or OA of lower limb joints other than the knee that, in the investigator's opinion, could interfere with pain and functional assessments related to the target knee.
  • Has a history of total or partial knee replacement, arthroplasty, or other knee surgery on the target knee.
  • In the investigator's opinion, has had significant injury involving the target knee within the 6 months before Screening.
  • Has skin lesions or wounds on or near the target knee at Screening or at Baseline (Day 1) that, in the investigator's opinion, would affect absorption of the medication.
Show all 35Show fewer
  • Has used opiates (including tramadol or tapentadol) or systemic corticosteroids within 30 days before Screening or requires treatment with chronic opiates or systemic corticosteroids.
  • Subjects with a placebo response exceeding 25% improvement in the average Western Ontario and McMaster Osteoarthritis Index [WOMAC] pain subscale score from Screening Visit to Day 1 will be excluded.
  • Has used gabapentin, pregabalin, antiepileptics, or specific antidepressants (i.e., tricyclics, serotonin norepinephrine reuptake inhibitors, or selective serotonin reuptake inhibitors) to treat pain in the 14 days before Screening. Other uses not related to the pain treatment may be permitted at the medical monitor's discretion provided they have been at a stable dose for at least 90 days.
  • Has had intra articular (IA) injections of corticosteroids, hyaluronic acid, or viscosupplements (e.g., Synvisc®) to the target knee within the 12 weeks before Screening
  • Has had IA or intravenous (IV) stem cell therapy in the 6 months prior to Screening
  • Is receiving or is planning to receive concomitant nonpharmacologic treatments (e.g., physiotherapy, acupuncture) that in the investigator's opinion could confound efficacy assessments within 14 days of Day 1.
  • Has a history of significant hypersensitivity, intolerance, or allergy to ibuprofen or any other NSAIDs, aspirin, or acetaminophen.
  • Has had an active gastrointestinal (GI) ulceration in the 6 months prior to Screening or a history of GI bleeding within 5 years of Screening.
  • Has used an anticoagulant or antiplatelet agent (except aspirin up to 325 mg/day for cardiac prophylaxis) in the 30 days prior to Screening.
  • Has a documented history of chronic inflammatory disease (e.g., rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, gouty arthritis) OR chronic pain condition (e.g., fibromyalgia), OR has other conditions that may affect the target joint for the functional and pain assessments (e.g., osteonecrosis, chondrocalcinosis).
  • Has uncontrolled depression or other uncontrolled psychiatric disorder (subjects with controlled depression or other psychiatric disorder, if using medication, must be on a stable dose of a medication other than an epileptic, tricyclic, serotonin norepinephrine reuptake inhibitor, or selective reuptake inhibitor for ≥12 weeks prior to Screening to participate in the study).
  • Has asthma requiring treatment with systemic corticosteroids in the last year prior to Screening. Asthmatic subjects using inhaled corticosteroids are eligible.
  • Has uncontrolled hypertension defined as systolic blood pressure >170 mmHg and diastolic blood pressure >90 mmHg at the Screening or Baseline Visit (may be repeated after 5 minutes rest to verify).
  • Is receiving systemic chemotherapy, has an active malignancy, lymphoproliferative disorder, or blood dyscrasia of any type, or has been diagnosed with cancer within 5 years before Screening. Subjects with completely excised squamous or basal cell carcinoma of the skin will be allowed.
  • Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, hepatic, or renal disease, or any other condition that, in the Investigator's opinion, could confound the study results, compromise the subject's welfare, interfere with the ability to communicate with the study staff, or otherwise contraindicate study participation.
  • Has any of the following conditions at Screening:
  • Acute hepatitis
  • Cirrhosis
  • Stage 4 or 5 end-stage renal disease
  • Subject has any other clinically significant laboratory finding at Screening that in the investigator's opinion contraindicates study participation.
  • Has clinically significant abnormality at Screening or Baseline (Day 1) on 12-lead ECG, including a QT interval calculated using Fridericia's correction (QTcF) interval >500 milliseconds (msec) or evidence of cardiac ischemia (i.e., Evident q waves: t wave inversion).
  • Is pregnant, planning to become pregnant during the study, or lactating. Has a positive serum and urine pregnancy test at Screening Visit, or a positive urine pregnancy test at Baseline (Day 1).
  • Has a positive urine drug screen for a nonprescribed drug prohibited by the protocol at Screening.
  • Has known alcohol or other substance abuse in the investigator's opinion.
  • Has participated in a previous clinical study with X0002.
  • Has participated in any other clinical trial within the past 30 days or within 5 half-lives of the study drug prior to Screening, whichever is longer.
  • Is a participating investigator, sub-investigator, study coordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.
  • Has any factor that, in the investigator's opinion, would jeopardize the evaluation or safety or be associated with poor adherence to the protocol.
  • Is without access to telephone and/or ability to gain technology access.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

United States33 sites

  • Orange County Research Institute

    Anaheim, California, 92801

  • Tekton Research

    Austin, Texas, 78745

  • Charlottesville Medical Research, LLC

    Charlottesville, Virginia, 22911

  • Chicago Clinical Research Institute Inc

    Chicago, Illinois, 60607

  • Northwestern University

    Chicago, Illinois, 60611

  • Aventiv Research, Inc - Brice Road Location

    Columbus, Ohio, 43213

  • Spectrum Medical, Inc

    Danville, Virginia, 24541

  • University Clinical Research-Deland

    DeLand, Florida, 32720

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • Healthcare Research Network

    Flossmoor, Illinois, 60422

  • DelRicht Research - Gulfport

    Gulfport, Mississippi, 39501

  • Healthcare Research Network, LLC

    Hazelwood, Missouri, 63042

  • Reliable Clinical Research

    Hialeah, Florida, 33012

  • Health Awareness Inc.

    Jupiter, Florida, 33458

  • AMR Kansas City

    Kansas City, Missouri, 64114

  • Biosolutions Clinical Research Center

    La Mesa, California, 91942

  • AMR: Las Vegas

    Las Vegas, Nevada, 89119

  • DelRicht Research

    New Orleans, Louisiana, 70124

  • Horizon Clinical Research

    Newnan, Georgia, 30263

  • Velocity Clinical Research

    North Hollywood, California, 91606

  • Affinity Health Corp

    Oak Brook, Illinois, 60523

  • Arizona Research Center

    Phoenix, Arizona, 85053

  • Ascension Research

    Pinellas Park, Florida, 33781

  • Clinical Investigations of Texas

    Plano, Texas, 75075

  • DelRicht Research

    Prairieville, Louisiana, 70769

  • Wasatch Clinical Research LLC

    Salt Lake City, Utah, 84107

  • Quality Research Inc.

    San Antonio, Texas, 78209

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • Pinnacle Trials Inc

    Stockbridge, Georgia, 30281

  • DelRicht Research

    Tulsa, Oklahoma, 74133

  • Upstate Clinical Research Associates LLC

    Williamsville, New York, 14221

  • Conquest Research

    Winter Park, Florida, 32789

  • Yuma Clinical Trials

    Yuma, Arizona, 85364

Other trials in United States

About this study

Official title: A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind, 22-Week and 30-Week Open-label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of X0002 Spray in Relief of the Pain for Subjects With Osteoarthritis of the Knee

This is a Phase 3, Multicenter, 22-Week, double-blind and 30-Week open label Study to Evaluate the Efficacy and Safety of X0002 Spray in relief of pain of subjects with Osteoarthritis of the Knee.

Read the detailed description

The study comprises a 14-day Screening Period, a 22-week Double-blind Treatment Period, and a 30-week Open-label Treatment Period, with an additional 4-week Follow-up Visit. Subjects will be randomized into a low-dose or high-dose group receiving either active or placebo treatment during the DB period.

The WOMAC version 3.1 using the NRS will be used for the primary and secondary efficacy endpoints. Safety assessments will include assessment of AEs, vital signs (blood pressure, respiratory rate, pulse rate, and oral temperature), clinical laboratory tests, physical examination, skin irritation, and electrocardiograms (ECGs).

Being tested
X0002
Keywords
Phase 3, Efficacy, Safety, Osteoarthritis, Knee, Pain
Medical subject headings
Osteoarthritis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • X0002Drug

    Subjects will complete 22 weeks of double-blind treatment and then enter into 30 weeks open-label treatment.

Study groups in NCT03081806
Study groupRoleWhat they receive
Group AExperimentalHigh dose group: X0002, BID (approximately every 12 hours; n=102); Placebo, BID(approximately every 12 hours; n=102)
Receives: Drug: X0002
Group BPlacebo comparatorLow dose group: X0002, BID (approximately every 12 hours; n=102); Placebo, BID(approximately every 12 hours; n=102)
Receives: Drug: X0002

What is being measured

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

  1. WOMAC pain subscale score in the target knee at Week 12 compared to Baseline

    To evaluate the effect of X0002 spray compared to placebo for relief of knee pain in subjects with OA of the knee as measured by the WOMAC pain subscale score in the target knee at Week 12.

    Measured: Week 12

Secondary outcomes (7)

  1. Subject's Global Assessment of Disease Status at Week 12.

    To evaluate the effect of X0002 spray for Subject's Global Assessment of Disease Status in subjects with OA of the knee in the target knee.

    Measured: Week 12 of treatment

  2. WOMAC fuctional subscale score in the target knee at Week 12

    To evaluate the effect of X0002 spray for relief of fuctional subscale in subjects with OA of the knee as measured by the WOMAC pain subscale score in the target knee at Week 12.

    Measured: Week 12 of treatment

  3. WOMAC (NRS) pain subscale in the target knee at Week 2, 4, 8, and 22

    To evaluate the efficacy of X0002 spray in average WOMAC (NRS) pain subscale in the target knee at Weeks 2, 4, 8, and 22

    Measured: Week 2, 4, 8 , and 22 of treatment

  4. WOMAC function subscale score

    To evaluate the efficacy of X0002 spray in changes of WOMAC function subscale score of subjects with osteoarthritis (OA) of the target knee at Week 2, 4, 8 and 22.

    Measured: Week 2, 4, 8 , and 22 of treatment

  5. Average eDiary daily (NRS) score in the target knee

    To evaluate the change from Baseline in average eDiary daily (NRS) score in the target knee for the 7 days prior to Weeks 2, 4, 8, 12, and 22.

    Measured: Week 2, 4, 8, 12 and 22 of treatment

  6. WOMAC overall score

    To evaluate the efficacy of X0002 spray in change WOMAC overall score of subjects with osteoarthritis (OA) of the target knee at Weeks 2, 4,8,12 and 22.

    Measured: Week 2, 4, 8, 12 and 22 of treatment

  7. WOMAC stiffness subscale

    To evaluate the efficacy of X0002 spray in change WOMAC stiffness subscale of subjects with osteoarthritis (OA) of the target knee at Weeks 2, 4,8,12 and 22.

    Measured: Week 2, 4, 8, 12 and 22 of treatment

Timeline

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

  1. First posted16 Mar 2017
  2. Study start24 Sep 2021
  3. Primary completion10 Jan 2024
  4. Study completion10 Jan 2024

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03081806
Sponsor's protocol ID
TF-X0002-31
Status last verified
Mar 2024
First submitted
10 Mar 2017
Last updated
28 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing X0002 in people with Pain Associated With Osteoarthritis of the Knee, run by Techfields Pharma Co. Ltd at 33 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 20 inclusion and 35 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 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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 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 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?

WOMAC pain subscale score in the target knee at Week 12 compared to Baseline (time frame: Week 12). 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 NCT03081806.

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 28 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in