SMPL
New Delhi [India], January 28: CliniExperts, one of India's premier Clinical Research Organizations, successfully conducted a phase III study on its biotherapeutic product, ALFLUTOP®, to assess the efficacy, safety, and tolerability in Indian patients with knee osteoarthritis. Such a scientific study proved ALFLUTOP® not just efficacious but could help in drastically improving the quality of life of patients in India, where osteoarthritis increasingly becomes a huge public health problem.
The study sought to fill a significant void in the current literature concerning the efficacy of ALFLUTOP® within the Indian demographic. Although the product has been available in the market for 27 years, showcasing a reliable and stable safety profile, the particular effects and safety of ALFLUTOP® in Indian patients had not been comprehensively investigated prior to this study. CliniExperts established a robust study design that involved 218 evaluable subjects, aged 40 to 75 years, who were randomly assigned to receive either ALFLUTOP® or standard care treatment over a duration of 56 days.
The clinical trial was structured as a prospective, randomized, double-blind, multicentric phase III study carried out at seven locations throughout India. Participants were administered either ALFLUTOP®, a natural chondroprotective product known for its anti-inflammatory properties, or standard care treatment over a duration of 20 days. The study comprised four distinct visits, facilitating comprehensive monitoring and assessment of the outcomes.
The primary endpoints were the percent change in WOMAC scores, a standardized process for assessing the impact of osteoarthritis on a patient's quality of life. Findings were striking out of 218 evaluable subjects, patients in the ALFLUTOP® group demonstrated a reduction in WOMAC pain score at week 4 by 29.4% in comparison with only 11.9% in the standard care group. By Week 8, the relative reduction of pain scores for ALFLUTOP® appeared to have increased to 45.7%, significantly outpacing that seen in the standard care group by 33.2%. The difference was statistically significant with a p-value <0.0001.
The quality-of-life profiles of patients were assessed with multiple questionnaires: OMERACT-OARSI, EQ-5D, Investigator Global Assessment (IGA), and Patient Global Health Questionnaires (PGHQ). Results showed a highly significant and consistent improvement in all quality-of-life measures in the treated patients with ALFLUTOP® at four weeks after starting the treatment. These results indicate that ALFLUTOP® may potentially decrease the severity of the disease and thus improve the general well-being of patients with knee osteoarthritis.
The safety profile of ALFLUTOP® was also impressive. A total of 65 adverse events were reported in 47 patients during the study period; all were of mild intensity, and no serious adverse event was recorded during the entire study period. This indicates the overall safety of the medication.
With the data provided from the study, CliniExperts looks forward to the introduction of ALFLUTOP® in India. What was observed in the course of the study in terms of consistent efficacy and imperceptible safety will definitely play a large role in improving the quality of life for patients with osteoarthritis.
The phase III study carried out by CliniExperts has successfully proven the efficacy, safety, and tolerability of ALFLUTOP® among the Indian population and marks an important milestone in the hunt for effective treatments of knee osteoarthritis. As ALFLUTOP® has clearly demonstrated its advantages, it is destined to play a very important role in the management of osteoarthritis. CliniExperts continues with its commitment to high-quality clinical research that pushes the frontiers of healthcare with respect to biotherapeutics and brings better health care outcomes for patients all over the nation.
For more information, please visit: https://cliniexperts-research.com/news/successful-study-for-alflutop/
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