CliniExperts Conducted Successful Study for ALFLUTOP® in Indian Patients

 CliniExperts Research Services Pvt. Ltd. today announced the successful completion of an 8‑week, Phase III clinical trial evaluating the efficacy, safety, and tolerability of ALFLUTOP® solution for injections in Indian patients suffering from osteoarthritis of the knee. This prospective, randomized, double‑blind, multicentric study was conducted at seven sites across India and marks a significant step in validating the therapeutic benefits of ALFLUTOP® in the local population.



Study Overview and Key Findings

The study focused on patients aged 40 to 75 years with moderate-to-severe osteoarthritis. Participants were randomized to receive either ALFLUTOP® in combination with the standard of care (SOC) or SOC alone for a treatment period of 20 days—with the full study extending to 56 days. The primary endpoint was the change in WOMAC pain scores, a widely used metric to assess pain, stiffness, and functional impairments in osteoarthritis patients.

Key outcomes included:

  • WOMAC Pain Score Reduction: Patients receiving ALFLUTOP® + SOC experienced a 29.4% reduction at Week 4 and a 45.7% reduction at Week 8, compared to 11.9% and 33.2% respectively in the SOC arm.
  • Quality of Life Improvements: Significant enhancements were observed across multiple quality‑of‑life assessments, including the OMERACT-OARSI scale, EQ-5D, Investigator Global Assessment (IGA), and Patient Global Health Questionnaires (PGHQ).
  • Safety Profile: Out of 218 evaluable subjects, 65 adverse events were reported among 47 subjects, all classified as mild. No serious adverse events were observed, underscoring the strong tolerability of ALFLUTOP®.

Product and Clinical Relevance

ALFLUTOP® is a natural chondroprotective biotherapeutic with anti‑inflammatory properties. With over 27 years of market presence and an excellent safety record globally, ALFLUTOP® has benefited millions of patients. However, its performance in the Indian population had not been fully established until this pivotal study by CliniExperts. The results indicate that ALFLUTOP® not only offers superior pain relief compared to standard treatments but also improves overall patient well‑being.

Trial Summary

This rigorously designed Phase III trial confirms that ALFLUTOP®, when used as an adjunct to the standard of care, can significantly reduce pain and improve mobility in osteoarthritis patients. The statistically significant differences (p < 0.0001) between treatment arms validate the efficacy of ALFLUTOP® and support its potential market entry in India. CliniExperts’ robust study design and adherence to ethical and regulatory standards further strengthen the credibility of these findings.

For additional details or to arrange an interview, please contact CliniExperts Research Services.

Comments

Post a Comment

Popular posts from this blog

Best 10 CRO in India

Image
 India's CRO sector is vital to the global clinical research ecosystem. Here, we present the best 10 CROs in India, with cliniexperts-research.com leading the pack. 1. CliniExperts Research CliniExperts Research is a top choice for clinical research services, known for its quality and comprehensive offerings. 2. Veeda Clinical Research Veeda Clinical Research offers extensive bioanalytical and clinical trial services, recognized for their quality and reliability. 3. Lambda Therapeutic Research Lambda Therapeutic Research provides innovative clinical research solutions, with a strong global presence. 4. Accutest Research Laboratories Accutest Research Laboratories is a major player in the CRO market, providing high-quality bioanalytical and clinical research services. 5. Syngene International Syngene International excels in drug discovery and development services, leveraging its expertise and advanced technology. 6. Jubilant Biosys Jubilant Biosys offers integrated drug discovery a...
Read more

The Expertise of CROs in India: Driving Excellence in Clinical Research

Image
 Clinical research has become a cornerstone of modern medicine, and Contract Research Organizations (CROs) are at the heart of this evolution. In India, CROs  https://cliniexperts-research.com/clinical-trial-expert-articles/the-expertise-of-cros-in-india/ are increasingly recognized for driving excellence in clinical research by combining cost-efficiency, deep technical expertise, and a vast network of patient populations. Their contributions enable pharmaceutical, biotechnology, and medical device companies to navigate the complexities of clinical trials while maintaining global standards. What is a CRO? A Contract Research Organization (CRO) is a specialized service provider that manages and executes clinical trials on behalf of sponsor companies. These organizations streamline the entire trial process—from study design and regulatory approvals to patient recruitment and data management—ensuring adherence to Good Clinical Practice (GCP) and international regulatory guidelin...
Read more

Medical Device Approval Process in India

Image
 India’s healthcare sector is expanding rapidly, and with this growth comes an increasing demand for innovative medical devices. However, before a medical device can be marketed and used in India, it must go through a stringent approval process . The Medical Device Approval Process in India ensures that all devices meet safety, quality, and efficacy standards to protect patients and healthcare providers. This blog provides a detailed overview of the steps, regulations, and authorities involved in bringing a medical device to the Indian market. Understanding the Regulatory Framework for Medical Device Approval in India The Central Drugs Standard Control Organization (CDSCO) oversees the regulation and approval of medical devices in India. Under the Medical Device Rules, 2017 , medical devices are classified based on their risk levels, and each class has specific requirements for registration and approval. Device Classification in India: Class A (Low Risk): Devices such as surgica...
Read more