Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis

NCT05324163 | Completed Phase 3

• 1 other identifier: TFR-X0002-301
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind clinical trial in a Chinese population

Conditions

KNEE OSTEOARTHRITIS

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of ibuprofen hydrochloride spray in the treatment of subjects' target knee osteoarthritis when compared with celecoxib capsules at 12 weeks of treatment with ibuprofen hydrochloride spray.

  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.

  week 12

Secondary Outcomes (7)

• Changes in WOMAC pain Scale scores for OA of the target knee compared to baseline at 1, 2, 4, and 8 weeks of treatment

  week1、week2、week4、week8

• At 1, 2, 4, 8, and 12 weeks of treatment, changes in the WOMAC Rigidity Scale score for OA of the target knee compared to baseline

  week1、week2、week4、week8

• Changes in WOMAC Daily Activity Scale scores for target knee OA compared to baseline at weeks 1, 2, 4, 8, and 12 of treatment

  week1、week2、week4、week8

• Changes in total WOMAC score for knee OA at 1, 2, 4, 8, and 12 weeks of treatment compared to baseline

  week1、week2、week4、week8

• At 1, 2, 4, 8, and 12 weeks of treatment, subjects self-assessed changes in OA of the target knee compared to baseline

  week1、week2、week4、week8

Other Outcomes (3)

• Change in the WOMAC pain Scale score of the subject's target knee OA from baseline at week 14 (or 2 weeks after the last medication)

  week14

• At 15min, 30min, 1h and 3h after the first, second and third days of treatment, the VAS score of OA of the target knee joint was changed from baseline

  15min, 30min, 1h and 3h after the first, second and third days of treatment

• Changes in subjects' joint cavity effusion at week 12 compared to baseline (only for some subjects)

  weer12

Study Arms (3)

X0002 spray group

EXPERIMENTAL

X0002 spray 17.5mg, twice a day; Celecoxib placebo 200mg, once a day

Drug: X0002 Spray; Drug: placebo

Celecoxib capsule Group:

ACTIVE COMPARATOR

X0002 spray placebo 17.5 mg, twice a day; Celecoxib capsule 200mg, once a day

Drug: Celecoxib capsules; Drug: placebo

The placebo group

PLACEBO COMPARATOR

X0002 spray placebo 17.5 mg, twice a day; Celecoxib placebo 200mg, once a day

Drug: placebo

Interventions

X0002 Spray DRUG

X0002 spray 17.5mg, twice a day; Celecoxib placebo 200mg, once a day

Also known as: Test drug

X0002 spray group

Celecoxib capsules DRUG

X0002 spray placebo 17.5 mg, twice a day; Celecoxib capsule 200mg, once a day

Also known as: Active comparator

Celecoxib capsule Group:

placebo DRUG

X0002 spray placebo 17.5 mg, twice a day; Celecoxibplacebo 200mg, once a day

Also known as: Placebo Spray

Celecoxib capsule Group:; The placebo group; X0002 spray group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 40 and 75 years old.
• A diagnosis of primary knee joint must be made by clinical and/or radiographic examination according to American College of Rheumatology standards
• Osteoarthritis (OA), meeting at least 4 of the following 6 criteria:
• ● Age ≥50
• Solution Number: TFR-X0002-301 Version 1.0 Date 2021-06-07
• Rigidity lasting less than 30 minutes after waking up in the morning
• (joint) twist pronunciation
• There is bone tenderness
• Bony enlargement
• No joint heating
• \. The history of clinical symptoms of OA of knee joint should be ≥6 months, and X-ray film of knee joint can be provided to confirm the presence of bone
• Hyperplasia or degeneration.
• \. Knee pain during standing, walking, and/or sports for at least 14 days in the 1 month prior to screening
• Pain.
• \. During the 7 days prior to randomization, knee pain was not treated with analgesics (study designated salvage)

You may not qualify if:

• \. Pelecoxib, any other NSaids, aspirin, acetaminophen, sulfa drugs
• Or the presence or history of alcohol allergy; Subjects are intolerant to or have used NSAIDs regularly
• NSAIDs drugs treat OA, but the effect is not good.
• \. Subject has a history of chronic pain (e.g., rheumatoid arthritis, psoriatic arthritis, gout joints)
• Inflammation, fibromyalgia), or other conditions that may affect the target knee function and pain assessment (e.g., bone
• Necrosis, cartilage calcification).
• \. Subjects' knee joints were secondary OA, or OA of lower limb joints other than knee joints, according to the investigator
• Judgment may affect the assessment of knee pain and function.
• \. Have a history of knee replacement, arthroplasty or other knee surgery.
• \. As determined by the investigator, subjects had significant injury involving the target knee in the 6 months prior to screening.
• \. Subjects' knee joint on or near the knee during the screening period or before the first use of the investigational drug (day 1)
• Skin lesions or cuts.
• \. Subjects had used opioids or glucocorticoid stimulation for the target knee in the 30 days prior to screening
• Element; Or requiring long-term treatment with opioids or glucocorticoids during the study period.
• \. Subjects received intraknee injections of steroids, hyaluronic acid, or adhesives within 3 months prior to screening

Sponsors & Collaborators

• Jiangsu XinChen-Techfields Pharma Co., LTD.: lead

Study Sites (1)

China,Beijing

Beijing, 100005, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Drug Evaluation; Celecoxib

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• xiaofeng zeng

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Assignment

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 12, 2022
• Study Start: September 29, 2021
• Primary Completion: February 6, 2023
• Study Completion: February 6, 2023
• Last Updated: March 7, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)