Osteoarthritis of the KneePhase 2NCT02067611
A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis
A Phase 2 study testing X0002 in people with Osteoarthritis of the Knee, run by Lina Xu at 20 sites in United States.
Trial summary
This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate OA of the knee. Objectives of the study: 1. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- X0002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 20 sitesUnited States
- Study dates
- Feb 2014to Apr 2016
- Phase
- Phase 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject must be a male or female between 35 and 85 years of age, inclusive.
- A subject must have a body mass index (BMI) between 18.5 and 39.9 kg/m2, inclusive.
- A subject must have a diagnosis of idiopathic OA according to the American College of Rheumatology (ACR) clinical and radiographic criteria (knee pain, osteophytes, and at least one of the following: >50 years of age, morning stiffness lasting <30 minutes after getting up in the morning, or crepitus).
- A subject must have a Kellgren Lawrence Grade of 1 or 2 as determined by the Investigator or a local radiologist at Screening.
- A subject must have a history of clinically symptomatic mild to moderate OA of the knee for ≥6 months.
- A subject must have had knee pain while standing, walking, and/or on motion for at least 14 days during the month prior to Screening.
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- A subject must have a knee pain score ≥40 mm and <90 mm on a 100 mm VAS (with or without analgesic medication) on at least 10 of the 14 days prior to randomization.
- A subject must be willing to discontinue any NSAIDs or other analgesic (eg, aspirin, acetaminophen) or potentially confounding concomitant treatments (eg, physiotherapy, acupuncture) starting 4 days before the administration of the first dose of study medication 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 Baseline (Day1), Week 2, Week 4, Week 8, Week 12/EOS, and Follow-up assessments.
- A subject must be willing to avoid unaccustomed physical activity (eg, starting a new weight lifting routine) for the duration of the study.
Who cannot join
- A subject who has secondary OA of the knee or OA of lower limb joints other than the knee that, in the opinion of the Investigator, could interfere with pain and functional assessments related to the knee
- A subject who has OA of the knee with a Kellgren Lawrence Grade ≥3 as determined by the Investigator or a local radiologist at Screening
- A subject who has a history of total or partial knee replacement, arthroplasty, or other knee surgery on either knee
- A subject who has had significant injury, as judged by the Investigator, involving the target knee within the 6 months before Screening.
- A subject who has skin lesions or wounds on or near the knees to be treated at Screening or on Day 1 prior to the first administration of study medication
- A subject who has used opiates or corticosteroids within 30 days before Screening or who requires treatment with chronic opiates or corticosteroids
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- A subject who has had intra articular injections of corticosteroids, hyaluronic acid, or viscosupplements (eg, Synvisc®) to a knee to be treated within the 3 months before Screening.
- A subject who has a history of significant hypersensitivity, intolerance, or allergy to ibuprofen, any NSAIDs, aspirin, or acetaminophen
- A subject who has had an active peptic ulceration in the 12 months prior to Screening or a history of gastrointestinal (GI) bleeding within 5 years of Screening
- A subject who has used an anticoagulant (except aspirin up to 325 mg/day for cardiac prophylaxis) in the month prior to Screening
- A subject who has positive results on fecal occult blood testing at Screening or on Day 1 prior to the first administration of study medication
- A subject who has a history of chronic inflammatory disease (such as rheumatoid arthritis, psoriatic arthritis, gouty arthritis), fibromyalgia, conditions that may affect the target joint (eg, osteonecrosis, chondrocalcinosis), or asthma.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
New Mexico Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, 87106
Heritage Valley Medical Group
Beaver, Pennsylvania, 15009
Med Center
Carmichael, California, 95608
Hightop Medical Research
Cincinnati, Ohio, 45224
Columbus Regional Research Institute
Columbus, Georgia, 31904
Clinical Research of South Florida
Coral Gables, Florida, 32720
Avail Clinical Research, LLC
DeLand, Florida, 32720
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Prestige Clinical Research, LLC
Franklin, Ohio, 45005
Healthcare Research Network
Hazelwood, Missouri, 63042-1755
Health Awareness Inc.
Jupiter, Florida, 33458
Suncoast Clinical Research, Inc
New Port Richey, Florida, 34652
Health Research of Hampton Roads, Inc
Newport News, Virginia, 23606
Clinical Trials Technology(CTT) Consultants, Inc.
Prairie Village, Kansas, 66206-1362
Quality Research Inc
San Antonio, Texas, 78209
Encompass Clinical Research
Spring Valley, California, 91978
Sundance Clinical Research, LLC
St Louis, Missouri, 63141-7068
Fiel Family & Sports Medicine/Clinical Research Advantage Inc
Tempe, Arizona, 85283-1528
New England Research Assoc.
Trumbull, Connecticut, 06611
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
About this study
Official title: A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study to Evaluate the Efficacy and Safety of X0002 Spray Versus Placebo in Subjects With Osteoarthritis
This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate OA of the knee.
Objectives of the study:
- To evaluate the efficacy of X0002 spray compared to placebo for relief of knee pain in subjects with osteoarthritis (OA) of the knee;
- To assess the safety and tolerability of multiple doses of X0002 when administered as a topical spray.
Read the detailed description
This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate OA of the knee.
After a screening period of up to 3 weeks and radiographic evaluation of the target knee joint space, 225 subjects will be randomly assigned to 1 of 3 treatment groups in a 1:1:1 ratio with a 2:1 ratio of active:placebo within each treatment group in a 1:1:1 ratio with a 2:1 ratio of active:placebo within each treatment group (i.e., 2 subjects to active treatment and 1 subject to placebo):
Group A: low dose of X0002, twice daily (BID, approximately every 12 hours; n=50) or placebo (low dose), BID (approximately every 12 hours; n=25); Group B: middle dose of X0002, BID (approximately every 12 hours; n=50) or placebo , BID (approximately every 12 hours; n=25) ; Group C: High dose of X0002, BID (approximately every 12 hours; n=50) or placebo, BID (approximately every 12 hours; n=25) .
Safety and efficacy assessments will be performed at at 2, 4, 8, and 12 weeks of treatment.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- X0002, Placebo
- Keywords
- Phase 2, Efficacy, Safety, Osteoarthritis
- 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.
X0002Drug
Also called Active drug
Parallel Assignment
PlaceboDrug
Also called Placebo powder
Parallel Assignment
| Study group | Role | What they receive |
|---|---|---|
| X0002 | Experimental | low dose, BID;middle dose, BID, or high dose, BID. Receives: Drug: X0002 |
| Placebo | Placebo comparator | low dose, BID; middle dose, BID, or high dose, BID. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the Efficacy of X0002 Spray Compared to Placebo for Relief of Knee Pain in Subjects With Osteoarthritis (OA) of the Knee
The Primary Efficacy Endpoint is change from Baseline in the WOMAC (VAS) pain subscale score for the target knee at 4 weeks of treatment, and will be analyzed using an analysis of covariance (ANCOVA). Treatment will be included as a fixed class effect and WOMAC Baseline pain subscale score as covariates. The primary comparisons of interest will be the difference between active Group A (low dose) and combined placebo, active Group B (middle dose) and combined placebo, and active Group C (high dose) and combined placebo.
Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned.
Measured: 4 weeks of treatment
Secondary outcomes (4)
To Assess the Safety and Tolerability of Multiple Doses of X0002 When Administered as a Topical Spray
A sensitivity analysis will also be conducted on the Primary Efficacy Endpoint using an ANCOVA with treatment as a fixed class effect and WOMAC baseline pain subscale score as covariates, but the comparisons of interest will be the difference between the active and placebo subjects within each treatment group.
The Secondary Efficacy Endpoints, change from Baseline in the WOMAC subscale scores for pain, stiffness, and functional ability, and overall WOMAC score at 2, 8, and 12 weeks of treatment, will be by analyzed using the same methods as the for the Primary Efficacy Endpoint.
Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned.
Measured: 2, 8, and 12 weeks of treatment
To Evaluate the Effect of X0002 Spray Compared to Placebo for the Relief of Joint Stiffness
A sensitivity analysis will also be conducted on the Primary Efficacy Endpoint using an ANCOVA with treatment as a fixed class effect and WOMAC baseline pain subscale score as covariates, but the comparisons of interest will be the difference between the active and placebo subjects within each treatment group.
The Secondary Efficacy Endpoints, change from Baseline in the WOMAC subscale scores for pain, stiffness, and functional ability, and overall WOMAC score at 2, 4, 8, and 12 weeks of treatment, will be by analyzed using the same methods as the for the Primary Efficacy Endpoint.
Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned.
Measured: 2, 4, 8, and 12 weeks of treatment
To Assess the Effect of X0002 Spray Compared to Placebo on Difficulty Performing Daily Activities
A sensitivity analysis will also be conducted on the Primary Efficacy Endpoint using an ANCOVA with treatment as a fixed class effect and WOMAC baseline pain subscale score as covariates, but the comparisons of interest will be the difference between the active and placebo subjects within each treatment group.
The Secondary Efficacy Endpoints, change from Baseline in the WOMAC subscale scores for pain, stiffness, and functional ability, and overall WOMAC score at 2, 8, and 12 weeks of treatment, will be by analyzed using the same methods as the for the Primary Efficacy Endpoint.
Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned.
Measured: at 2, 4, 8, and 12 weeks of treatment
Characterize the Pharmacokinetics of X0002
Cmax, Tmax, AUCs, apparent terminal elimination rate constant, apparent terminal elimination half-life will be calculated.
Measured: at the Week 2, week 3, week 4 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis of the 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lina Xu
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Lina Xu, Techfields Pharma Co. Ltd
- Investigators
- Chongxi Yu, Ph.D., Study chair, Techfields Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067611
- Sponsor's protocol ID
- TF-X0002-21
- Status last verified
- Feb 2018
- First submitted
- 18 Feb 2014
- Last updated
- 7 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study to Evaluate the Efficacy and Safety of X0002 Spray Versus Placebo in Subjects With Osteoarthritis
- ClinicalTrials.gov ID
- NCT02067611
- Acronym / sponsor ID
- TF-X0002-21
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Phase 2, Efficacy, Safety, Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Lina XuIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Posted 7 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate OA of the knee.
Objectives of the study:
- To evaluate the efficacy of X0002 spray compared to placebo for relief of knee pain in subjects with osteoarthritis (OA) of the knee;
- To assess the safety and tolerability of multiple doses of X0002 when administered as a topical spray.
Detailed description
This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate OA of the knee.
After a screening period of up to 3 weeks and radiographic evaluation of the target knee joint space, 225 subjects will be randomly assigned to 1 of 3 treatment groups in a 1:1:1 ratio with a 2:1 ratio of active:placebo within each treatment group in a 1:1:1 ratio with a 2:1 ratio of active:placebo within each treatment group (i.e., 2 subjects to active treatment and 1 subject to placebo):
Group A: low dose of X0002, twice daily (BID, approximately every 12 hours; n=50) or placebo (low dose), BID (approximately every 12 hours; n=25); Group B: middle dose of X0002, BID (approximately every 12 hours; n=50) or placebo , BID (approximately every 12 hours; n=25) ; Group C: High dose of X0002, BID (approximately every 12 hours; n=50) or placebo, BID (approximately every 12 hours; n=25) .
Safety and efficacy assessments will be performed at at 2, 4, 8, and 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| X0002 | Experimental | Drug: X0002low dose, BID;middle dose, BID, or high dose, BID. |
| Placebo | Placebo comparator | Drug: Placebolow dose, BID; middle dose, BID, or high dose, BID. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A subject must be a male or female between 35 and 85 years of age, inclusive.
- A subject must have a body mass index (BMI) between 18.5 and 39.9 kg/m2, inclusive.
- A subject must have a diagnosis of idiopathic OA according to the American College of Rheumatology (ACR) clinical and radiographic criteria (knee pain, osteophytes, and at least one of the following: >50 years of age, morning stiffness lasting <30 minutes after getting up in the morning, or crepitus).
- A subject must have a Kellgren Lawrence Grade of 1 or 2 as determined by the Investigator or a local radiologist at Screening.
- A subject must have a history of clinically symptomatic mild to moderate OA of the knee for ≥6 months.
Key exclusion criteria (12 listed)
- A subject who has secondary OA of the knee or OA of lower limb joints other than the knee that, in the opinion of the Investigator, could interfere with pain and functional assessments related to the knee
- A subject who has OA of the knee with a Kellgren Lawrence Grade ≥3 as determined by the Investigator or a local radiologist at Screening
- A subject who has a history of total or partial knee replacement, arthroplasty, or other knee surgery on either knee
- A subject who has had significant injury, as judged by the Investigator, involving the target knee within the 6 months before Screening.
- A subject who has skin lesions or wounds on or near the knees to be treated at Screening or on Day 1 prior to the first administration of study medication
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 |
|---|---|---|
| X0002Also: Active drugParallel Assignment | Drug | X0002 |
| PlaceboAlso: Placebo powderParallel Assignment | Drug | Placebo |
Primary outcome
To Evaluate the Efficacy of X0002 Spray Compared to Placebo for Relief of Knee Pain in Subjects With Osteoarthritis (OA) of the Knee
Time frame: 4 weeks of treatment
The Primary Efficacy Endpoint is change from Baseline in the WOMAC (VAS) pain subscale score for the target knee at 4 weeks of treatment, and will be analyzed using an analysis of covariance (ANCOVA). Treatment will be included as a fixed class effect and WOMAC Baseline pain subscale score as covariates. The primary comparisons of interest will be the difference between active Group A (low dose) and combined placebo, active Group B (middle dose) and combined placebo, and active Group C (high dose) and combined placebo. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned.
4 secondary outcomes
To Assess the Safety and Tolerability of Multiple Doses of X0002 When Administered as a Topical Spray
Time frame: 2, 8, and 12 weeks of treatment
To Evaluate the Effect of X0002 Spray Compared to Placebo for the Relief of Joint Stiffness
Time frame: 2, 4, 8, and 12 weeks of treatment
To Assess the Effect of X0002 Spray Compared to Placebo on Difficulty Performing Daily Activities
Time frame: at 2, 4, 8, and 12 weeks of treatment
Characterize the Pharmacokinetics of X0002
Time frame: at the Week 2, week 3, week 4 and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Chongxi Yu, Ph.D. study chair
Techfields Inc
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing X0002 in people with Osteoarthritis of the Knee, run by Lina Xu at 20 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 9 inclusion and 12 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 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 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 7 Feb 2018). 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?
To Evaluate the Efficacy of X0002 Spray Compared to Placebo for Relief of Knee Pain in Subjects With Osteoarthritis (OA) of the Knee (time frame: 4 weeks of treatment). 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 7 Feb 2018.