Phase 4
Completed N=606
Study on Efficacy and Safety of Chondroitin Sulfate + Glucosamine Hydrochloride Versus Celecoxib in Knee Osteoarthritis
Source: ClinicalTrials.gov NCT01425853 ↗Enrolled (actual)
606
Serious AEs
2.8%
Results posted
Feb 2016
Primary outcomePrimary: WOMAC Pain Subscale — 185.79; 184.67 units on a scale
Summary
The purpose of this study is to determine whether the combination of Chondroitin sulfate (CS) and Glucosamine Hydrochloride (GH) has similar efficacy to Celecoxib (CE) in the treatment of patients with moderate to severe knee osteoarthritis (OA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY WOMAC Pain Subscale |
185.79; 184.67 | — |
| SECONDARY WOMAC Stiffness Subscale |
130.15; 129.48; 69.06; 65.78 | — |
| SECONDARY WOMAC Function Subscale |
1131.40; 1111.60; 616.96; 595.78 | — |
| SECONDARY Huskisson's VAS |
72.79; 73.47; 37.86; 37.64 | — |
| SECONDARY Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) |
79.7; 79.2 | — |
| SECONDARY Percentage of Presence of Joint Swelling |
5.9; 4.5 | — |
| SECONDARY Percentage of Presence of Joint Effusion |
4.1; 3.8 | — |
| SECONDARY Consumption of Rescue Medication |
31.0; 29.0 | — |
| SECONDARY Patient's Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity |
69.11; 69.41; 38.35; 36.88; 63.2; 63.28 | — |
| SECONDARY Patient's and Investigator's Global Assessment of Response to Therapy |
54.59; 45.9; 36.85; 36.04; 51.4; 42.25 | — |
| SECONDARY Health Status According to EuroQoL |
1.84; 1.84; 1.52; 1.46; 1.39; 1.44 | — |
| SECONDARY Number of Participants With at Least One Adverse Events |
155; 151 | — |
| SECONDARY Number of Adverse Events Defined by Relationship With Treatment |
3; 10; 43; 38; 25; 12 | — |
| SECONDARY Biomarker Analysis |
— | — |
Eligibility Criteria
Inclusion Criteria
- At least 40 years of age
- Primary OA of the knee according to the American College of Rheumatology (ACR) criteria
- OA of radiological stages II or III according to Kellgren and Lawrence
- Patients with moderate-severe knee pain
Exclusion Criteria
- Subjects with active malignancy of any type or history of a malignancy within the last five years
- Concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis seronegative spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease
- Pain in other parts of the body greater than the knee pain that could interfere with the evaluation of the index joint
- Patients with fibromyalgia
- Subjects with a history of heart attack or stroke, or who have experienced chest pain related to heart disease, or who have had serious diseases of the heart
- Subjects with high risk of cardiovascular (CV) events
- Subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, HIV positivity) or fungal infections
- Subjects with a history of recurrent Upper Gastrointestinal (UGI) ulceration or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a significant coagulation defect
- Subjects who have been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication
- Washout period for OA treatments before beginning the study.
Data sourced from ClinicalTrials.gov (NCT01425853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.