KNEE OSTEOARTHRITISPhase 2NCT03691818
Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis
A Phase 2 study testing X0002 Spray and Ibuprofen Tablet in people with KNEE OSTEOARTHRITIS, run by Tianjin XinChen-Techfields Pharma Co., LTD. at 1 site in China.
Trial summary
This study is a randomized, double-blind clinical trial in a Chinese population. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- KNEE OSTEOARTHRITIS
- What is being tested?
- X0002 Spray and Ibuprofen Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 353 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2018to 21 Oct 2019
- Phase
- Phase 2
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Ability to read and provide written, personally signed, and dated informed consent to participate in the study, in accordance with the GCP and applicable regulations, before completing any study related procedures.
- 2. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
- 3. Subject must be a male or female between 40 and 75 years of age, inclusive.
- 4. 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: Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on the subjects usual menstrual cycle period) before study drug administration.
- Intrauterine device.
- Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream).
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- 5. Subject must have a diagnosis of idiopathic OA according to the American College of Rheumatology clinical and radiographic criteria, and fulfillment of at least four of the 6 criteria: age of ≥50 years stiffness lasting <30 minutes after getting up in the morning crepitus Bone tenderness Bone enlargement No joint fever
- 6. Subject must have a history of clinically symptomatic OA of the knee for ≥6 months.
- 7. Subject must have had knee pain while standing, walking, and/or in motion for at least 14 days during the month prior to screening.
- 8. Subject must have a knee pain score ≥40 mm and <90 mm on a 100 mm VAS (without analgesic medication) on at least 7 of the 10 days prior to randomization(according to the subject's diary card records).
- 9. Subject must have a WOMAC pain average score of knee ≥40 mm and <90 mm starting on the first screening visit.
- 10. Subject must be willing to discontinue any NSAIDs or other analgesic (e.g. aspirin) or potentially confounding concomitant treatments (e.g. 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 14.
- 11. 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.) 12. Subject must be willing to avoid unaccustomed physical activity (e.g. starting a new weight lifting routine) for the duration of the study starting on the first screening visit.
- 13. With the exception of OA of the knee, the subject must be in good general health with no clinically significant findings from medical history, vital signs, physical examination, ECG, and routine laboratory tests that could interfere with subject safety, or pain and functional assessments, as determined by the Investigator.
Who cannot join
- 1. The subject had a history of trauma, and the injury affected the knee joint.
- 2. 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.
- 3. Subject who has a history of total or partial knee replacement, arthroplasty, or other knee surgery on either knee.
- 4. Subject who has had significant injury, as estimated by the Investigator, involving the target knee within the 6 months before screening.
- 5. 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.
- 6. Subject who has used opiates or corticosteroids within 30 days before screening for the target knee or who requires treatment with chronic opiates or corticosteroids.
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- 7. Subject who has had intra articular injections of corticosteroids, hyaluronic acid, or viscosupplements (e.g. Synvisc®) to a knee to be treated within the 3 months before screening.
- 8. Subject who has a history of significant hypersensitivity, intolerance, or allergy to ibuprofen, any NSAIDs, aspirin, or acetaminophen.
- 9. Subject who has had an active peptic ulceration in the 6 months prior to screening or a history of gastrointestinal (GI) bleeding within 5 years of screening.
- 10. Subject who has used an anticoagulant (except aspirin up to 325 mg/day for cardiac prophylaxis) in the month prior to Screening.
- 11. Subject who has positive results on fecal occult blood testing at screening or on Day 1 prior to the first administration of study medication.
- 12. Subject who has a history of chronic inflammatory disease (such as rheumatoid arthritis, psoriatic arthritis, gouty arthritis), fibromyalgia, or other conditions that may affect the target joint or the functional and pain assessments (e.g. osteonecrosis, chondrocalcinosis).
- 13. Subject is an asthmatic requiring treatment with systemic corticosteroids. Asthmatic subjects using inhaled corticosteroids are eligible.
- 14. Subject has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease, or any other condition that, in the investigators opinion, could compromise the subjects welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.
- 15. Subject has a significant renal or hepatic disease, as indicated by clinical laboratory assessment,defined as
- aspartate aminotransferase, alanine aminotransferase, and lactate dehydrogenase≥3 × the upper limit of normal
- creatinine ≥1.5 × ULN
- hemoglobin<10g/dL.
- 16. Subject has any other clinically significant laboratory finding at Screening that in the investigators opinion contraindicates study participation.
- 17. Subject is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before Screening (excluding squamous or basal cell carcinoma of the skin).
- 18. Subject has clinically significant abnormality on 12-lead ECG, including a QTc interval >450 msecs for males and 470 msecs for females.
- 19. Subject has uncontrolled hypertension defined as systolic blood pressure >170 mmHg and diastolic blood pressure >90 mmHg at baseline (may be repeated after 5 minutes rest to verify).
- 20. Subject is female and pregnant, planning to become pregnant during the study, or nursing.
- 21. Subject participated in a previous clinical study with bromine hydrochloride spray.
- 22. Subjects with known alcohol or other substance abuse.
- 23. Subject participated in any other clinical trial within the past 3 months or 5 half-lives, whichever is longer.
- 24. Subject is a participating Investigator, sub-investigator, study coordinator, or employee of a participating Investigator, or is an immediate family member of the aforementioned.
- 25. Any factor, which in the opinion of the Investigator would jeopardize the evaluation or safety or be associated with poor adherence to the protocol.
- 26. Subjects without access to telephone and/or ability to gain technology access.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Science & Peking Union Medical college Hospital
Beijing, Beijing Municipality, 100005
About this study
Official title: A Phase 2, Multicenter, Double-blind and Placebo and Active Control Study to Evaluate the Initial Efficacy and Safety of X0002 Spray in Treatment of Subjects With Osteoarthritis of the Knee
This study is a randomized, double-blind clinical trial in a Chinese population.
Read the detailed description
This study is a randomized, double-blind clinical trial in a Chinese population. Active drug and placebo were used as controls to observe the relative efficacy of X0002 spray.
- Conditions
- KNEE OSTEOARTHRITIS
- Being tested
- X0002 Spray, Ibuprofen Tablet, Ibuprofen Placebo Tab, X0002 Placebo Spray
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X0002 SprayDrug
Also called Test drug
According to the different dose groups assigned, each knee joint was sprayed with 1, 2 or 4 sprays.
Ibuprofen TabletDrug
Also called Active drug
Ibuprofen Tab 400mg, tid.
Ibuprofen Placebo TabDrug
Also called Placebo Oral Tablet
Ibuprofen Placebo Tab 400mg, tid.
X0002 Placebo SprayDrug
Also called Placebo Spray
According to the different dose groups assigned, each knee joint was sprayed with 1, 2 or 4 sprays.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose test drug group | Experimental | X0002 Spray 1 Spray/time/Knee, 2 times/day; Ibuprofen Placebo Tab 400 mg/time, 3 times /day. Receives: Drug: X0002 Spray; Drug: Ibuprofen Placebo Tab |
| Low-dose active drug control group | Active comparator | Ibuprofen Tablet 400 mg/time, 3 times /day; X0002 Placebo Spray 1 Spray/time/Knee, 2 times/day. Receives: Drug: Ibuprofen Tablet; Drug: X0002 Placebo Spray |
| Low-dose placebo control group | Placebo comparator | Placebo Spray 1 Spray/time/Knee, 2 times/day; Ibuprofen Placebo Tab 400 mg/time, 3 times/day. Receives: Drug: Ibuprofen Placebo Tab; Drug: X0002 Placebo Spray |
| Medium-dose test drug group | Experimental | X0002 Spray 2 Spray/time/Knee, 2 times/day; Ibuprofen Placebo Tab 400 mg/time, 3 times /day. Receives: Drug: X0002 Spray; Drug: Ibuprofen Placebo Tab |
| Medium-dose active drug control group | Active comparator | X0002 Placebo Spray 2 Spray/time/Knee, 2 times/day; Ibuprofen Tablet 400 mg/time, 3 times /day. Receives: Drug: Ibuprofen Tablet; Drug: X0002 Placebo Spray |
| Medium-dose placebo control group | Placebo comparator | X0002 Placebo Spray 2 Spray/time/Knee, 2 times/day; Ibuprofen Placebo Tab 400 mg/time, 3 times /day. Receives: Drug: Ibuprofen Placebo Tab; Drug: X0002 Placebo Spray |
| High-dose test drug group | Experimental | X0002 Spray 4 Spray/time/Knee, 2 times/day; Ibuprofen Placebo Tab 400 mg/time, 3 times /day. Receives: Drug: X0002 Spray; Drug: Ibuprofen Placebo Tab |
| High-dose active drug control group | Active comparator | X0002 Placebo Spray 4 Spray/time/Knee, 2 times/day; Ibuprofen Tablet 400 mg/time, 3 times /day. Receives: Drug: Ibuprofen Tablet; Drug: X0002 Placebo Spray |
| High-dose placebo control group | Placebo comparator | X0002 Placebo Spray 4 Spray/time/Knee, 2 times/day; Placebo Tablet 400 mg/time, 3 times /day. Receives: Drug: Ibuprofen Placebo Tab; Drug: X0002 Placebo Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Subject's Target OA Knee Compared to the Baseline as Assessed by WOMAC
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) has been used to assess subjects with OA of the hip or knee and consists of 24 questions in subscales measuring 3 concepts: pain, stiffness, and physical function. These questions measure the amount of pain, degree of difficulty in completing various day-to-day activities, and stiffness experienced in the hip or knee. Usually subject self-administered. A single question has 100 grades, where 0 = very good and 100 = very much worse. VAS (visual analog scale) scale is used for score record.
Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.
Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics.
Measured: week 12
Secondary outcomes (10)
Incidence of Treatment-Emergent Adverse Events of X0002 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, 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: week 1 to week 14
Relief of Knee Pain in Subjects With Osteoarthritis (OA) of the Knee as Evaluated by WOMAC Subscale
The WOMAC pain subscale has 5 questions. Usually subject self-administered. A single question has 100 grades, where 0 = no pain and 100 = pain as bad as can be.
The Primary Efficacy Endpoint is change from Baseline in the WOMAC (VAS) pain subscale score for the target knee at week 2, 4, 8, and will be analyzed by an analysis of covariance (ANCOVA). Treatment will be included as a fixed class effect and WOMAC Baseline pain subscale score as covariates.
Measured: week 2，4，8
Relief of Joint Stiffness After Using X0002 Spray as Evaluated by WOMAC Subscale
The WOMAC stiffness subscale has 2 questions. Usually subject self-administered. A single question has 100 grades, where 0 = no stiffness and 100 = stiffness as bad as can be.
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 stiffness 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 stiffness 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: week 2，4，8, 12
Difficulty Performing Daily Activities of OA Subjects as Assessed by WOMAC subscale
The WOMAC physical function subscale has 17 questions. Usually subject self-administered. A single question has 100 grades, where 0 = very good and 100 = very much worse.
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: week 2，4，8, 12
Total Score of WOMAC Subscale as Estimated by Visual Analog Scale
The WOMAC subscale has 24 questions. Usually subject self-administered. A single question has 100 grades, where 0 = very good and 100 = very much worse. The total score is 2400, the lower, the better; higher score means worse condition.
Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.
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: week 2，4，8, 12
Subject's Global Assessment of Disease Status of the Target Knee as Estimated by Visual Analog Scale at 2, 4, 8 and 12 Weeks of Treatment
The subject's overall evaluation of the condition is the relevant questionnaire (0-100mm visual analogue scale), which needs to be completed at the time points listed in the study flow chart. On the scale line of 100mm VAS, mark the left side to indicate "very good" and mark the right side means "Very bad." Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.
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: week 2，4，8, 12
Subject's Global Assessment of Response to Therapy of the Target Knee as Estimated by Visual Analog Scale at 2, 4, 8 and 12 Weeks of Treatment
The subjects' overall evaluation of treatment response is that they fill in the relevant questionnaire VAS (visual analog scale) (VAS, 0~4 points), which should be completed in the time points listed in the study flow chart. 0 = very poor; 4 = very good.
Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.
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: week 2，4，8, 12
Amount of Rescue Medication (Acetaminophen) Consumed Per Day for Target Knee Pain
Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.
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: week 2，4，8, 12
Pharmacokinetic parameters(Maximum Plasma Concentration [Cmax]) of X0002
Cmax of X0002 will be calculated.
Measured: 1 h pre-dose, 1±0.5 h post-dose, 3±0.5 h post-dose, 5±0.5 h post-dose at week 8; 1 h pre-dose, 2±0.5 h post-dose, 4±0.5 h post-dose, 6±0.5 h post-dose at week 12
Pharmacokinetic parameters(Area Under Curve [AUC]) of X0002
AUC of X0002 will be calculated.
Measured: 1 h pre-dose, 1±0.5 h post-dose, 3±0.5 h post-dose, 5±0.5 h post-dose at week 8; 1 h pre-dose, 2±0.5 h post-dose, 4±0.5 h post-dose, 6±0.5 h post-dose at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start16 Jul 2018
- Primary completion21 Oct 2019
- Study completion21 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KNEE OSTEOARTHRITISStudies 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
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin XinChen-Techfields Pharma Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zeng Xiaofeng, Principal investigator, lead institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691818
- Sponsor's protocol ID
- TFR-X0002-201
- Status last verified
- Jan 2019
- First submitted
- 3 Sep 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Double-blind and Placebo and Active Control Study to Evaluate the Initial Efficacy and Safety of X0002 Spray in Treatment of Subjects With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT03691818
- Acronym / sponsor ID
- TFR-X0002-201
- Conditions
- KNEE OSTEOARTHRITIS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Tianjin XinChen-Techfields Pharma Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 2 Oct 2018 (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 is a randomized, double-blind clinical trial in a Chinese population.
Detailed description
This study is a randomized, double-blind clinical trial in a Chinese population. Active drug and placebo were used as controls to observe the relative efficacy of X0002 spray.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Low-dose test drug group | Experimental | Drug: X0002 Spray, Drug: Ibuprofen Placebo TabX0002 Spray 1 Spray/time/Knee, 2 times/day; Ibuprofen Placebo Tab 400 mg/time, 3 times /day. |
| Low-dose active drug control group | Active comparator | Drug: Ibuprofen Tablet, Drug: X0002 Placebo SprayIbuprofen Tablet 400 mg/time, 3 times /day; X0002 Placebo Spray 1 Spray/time/Knee, 2 times/day. |
| Low-dose placebo control group | Placebo comparator | Drug: Ibuprofen Placebo Tab, Drug: X0002 Placebo SprayPlacebo Spray 1 Spray/time/Knee, 2 times/day; Ibuprofen Placebo Tab 400 mg/time, 3 times/day. |
| Medium-dose test drug group | Experimental | Drug: X0002 Spray, Drug: Ibuprofen Placebo TabX0002 Spray 2 Spray/time/Knee, 2 times/day; Ibuprofen Placebo Tab 400 mg/time, 3 times /day. |
| Medium-dose active drug control group | Active comparator | Drug: Ibuprofen Tablet, Drug: X0002 Placebo SprayX0002 Placebo Spray 2 Spray/time/Knee, 2 times/day; Ibuprofen Tablet 400 mg/time, 3 times /day. |
| Medium-dose placebo control group | Placebo comparator | Drug: Ibuprofen Placebo Tab, Drug: X0002 Placebo SprayX0002 Placebo Spray 2 Spray/time/Knee, 2 times/day; Ibuprofen Placebo Tab 400 mg/time, 3 times /day. |
| High-dose test drug group | Experimental | Drug: X0002 Spray, Drug: Ibuprofen Placebo TabX0002 Spray 4 Spray/time/Knee, 2 times/day; Ibuprofen Placebo Tab 400 mg/time, 3 times /day. |
| High-dose active drug control group | Active comparator | Drug: Ibuprofen Tablet, Drug: X0002 Placebo SprayX0002 Placebo Spray 4 Spray/time/Knee, 2 times/day; Ibuprofen Tablet 400 mg/time, 3 times /day. |
| High-dose placebo control group | Placebo comparator | Drug: Ibuprofen Placebo Tab, Drug: X0002 Placebo SprayX0002 Placebo Spray 4 Spray/time/Knee, 2 times/day; Placebo Tablet 400 mg/time, 3 times /day. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1. Ability to read and provide written, personally signed, and dated informed consent to participate in the study, in accordance with the GCP and applicable regulations, before completing any study related procedures.
- 2. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
- 3. Subject must be a male or female between 40 and 75 years of age, inclusive.
- 4. 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: Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on the subjects usual menstrual cycle period) before study drug administration.
- 5. Subject must have a diagnosis of idiopathic OA according to the American College of Rheumatology clinical and radiographic criteria, and fulfillment of at least four of the 6 criteria: age of ≥50 years stiffness lasting <30 minutes after getting up in the morning crepitus Bone tenderness Bone enlargement No joint fever
Key exclusion criteria (29 listed)
- 1. The subject had a history of trauma, and the injury affected the knee joint.
- 2. 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.
- 3. Subject who has a history of total or partial knee replacement, arthroplasty, or other knee surgery on either knee.
- 4. Subject who has had significant injury, as estimated by the Investigator, involving the target knee within the 6 months before screening.
- 5. 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 |
|---|---|---|
| X0002 SprayAlso: Test drugAccording to the different dose groups assigned, each knee joint was sprayed with 1, 2 or 4 sprays. | Drug | High-dose test drug group, Low-dose test drug group, Medium-dose test drug group |
| Ibuprofen TabletAlso: Active drugIbuprofen Tab 400mg, tid. | Drug | High-dose active drug control group, Low-dose active drug control group, Medium-dose active drug control group |
| Ibuprofen Placebo TabAlso: Placebo Oral TabletIbuprofen Placebo Tab 400mg, tid. | Drug | High-dose placebo control group, High-dose test drug group, Low-dose placebo control group, Low-dose test drug group, Medium-dose placebo control group, Medium-dose test drug group |
| X0002 Placebo SprayAlso: Placebo SprayAccording to the different dose groups assigned, each knee joint was sprayed with 1, 2 or 4 sprays. | Drug | High-dose active drug control group, High-dose placebo control group, Low-dose active drug control group, Low-dose placebo control group, Medium-dose active drug control group, Medium-dose placebo control group |
Primary outcome
Change of the Subject's Target OA Knee Compared to the Baseline as Assessed by WOMAC
Time frame: week 12
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) has been used to assess subjects with OA of the hip or knee and consists of 24 questions in subscales measuring 3 concepts: pain, stiffness, and physical function. These questions measure the amount of pain, degree of difficulty in completing various day-to-day activities, and stiffness experienced in the hip or knee. Usually subject self-administered. A single question has 100 grades, where 0 = very good and 100 = very much worse. VAS (visual analog scale) scale is used for score record. Data for the exploratory efficacy endpoints will be summarized using descriptive statistics. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics.
10 secondary outcomes
Incidence of Treatment-Emergent Adverse Events of X0002 Spray
Time frame: week 1 to week 14
Relief of Knee Pain in Subjects With Osteoarthritis (OA) of the Knee as Evaluated by WOMAC Subscale
Time frame: week 2，4，8
Relief of Joint Stiffness After Using X0002 Spray as Evaluated by WOMAC Subscale
Time frame: week 2，4，8, 12
Difficulty Performing Daily Activities of OA Subjects as Assessed by WOMAC subscale
Time frame: week 2，4，8, 12
Total Score of WOMAC Subscale as Estimated by Visual Analog Scale
Time frame: week 2，4，8, 12
Subject's Global Assessment of Disease Status of the Target Knee as Estimated by Visual Analog Scale at 2, 4, 8 and 12 Weeks of Treatment
Time frame: week 2，4，8, 12
Subject's Global Assessment of Response to Therapy of the Target Knee as Estimated by Visual Analog Scale at 2, 4, 8 and 12 Weeks of Treatment
Time frame: week 2，4，8, 12
Amount of Rescue Medication (Acetaminophen) Consumed Per Day for Target Knee Pain
Time frame: week 2，4，8, 12
Pharmacokinetic parameters(Maximum Plasma Concentration [Cmax]) of X0002
Time frame: 1 h pre-dose, 1±0.5 h post-dose, 3±0.5 h post-dose, 5±0.5 h post-dose at week 8; 1 h pre-dose, 2±0.5 h post-dose, 4±0.5 h post-dose, 6±0.5 h post-dose at week 12
Pharmacokinetic parameters(Area Under Curve [AUC]) of X0002
Time frame: 1 h pre-dose, 1±0.5 h post-dose, 3±0.5 h post-dose, 5±0.5 h post-dose at week 8; 1 h pre-dose, 2±0.5 h post-dose, 4±0.5 h post-dose, 6±0.5 h post-dose at week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: No
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Knee Osteoarthritis
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.
Zeng Xiaofeng principal investigator
lead institution
1 site 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 Spray and Ibuprofen Tablet in people with KNEE OSTEOARTHRITIS, run by Tianjin XinChen-Techfields Pharma Co., LTD. at 1 site in China.
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 14 inclusion and 29 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 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
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?
Change of the Subject's Target OA Knee Compared to the Baseline as Assessed by WOMAC (time frame: 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 13 Jan 2020.