A Prospective, Multicenter, Single-arm, Phase IV Study to Assess the Safety and Effectiveness of a Fixed-Dose Combination of Pregabalin Prolonged Release and Etoricoxib in Patients with Chronic Low Back Pain with a Neuropathic Component - Takeaways - MDSpire

A Prospective, Multicenter, Single-arm, Phase IV Study to Assess the Safety and Effectiveness of a Fixed-Dose Combination of Pregabalin Prolonged Release and Etoricoxib in Patients with Chronic Low Back Pain with a Neuropathic Component

  • By

  • Sandesh Sahebrao Patil

  • Brijesh Jerambhai Patel

  • Bhavsar Neel Mahendrabhai

  • C. L. Nawal

  • B. Valya

  • K. Sanjeev Kumar

  • Pandurang Wattamwar

  • Rana Kaushikkumar Ramanlal

  • Swagat Shah

  • Mandodari Rajurkar

  • Supriya Sonowal

  • Dipak Patil

  • Pravin Ghadge

  • Suyog Mehta

  • March 12, 2026

  • 0 min

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  • 1

    The fixed-dose combination of pregabalin 75 mg and etoricoxib 60 mg was well tolerated with only 7.18% of patients experiencing mild or moderate adverse effects.

  • 2

    Patients reported significant pain relief and improved daily functioning over the 8-week treatment period, as indicated by better scores on pain and disability scales.

  • 3

    The need for additional 'rescue' medication decreased during the study, indicating enhanced pain control from the combination treatment over time.

  • 4

    This combination effectively addresses both neuropathic and nociceptive pain components, showing promise as a treatment for chronic low back pain.

  • 5

    The study was conducted in a real-world setting across nine hospitals in India, fulfilling post-approval regulatory requirements for the fixed-dose combination.

Original Source(s)

A Prospective, Multicenter, Single-arm, Phase IV Study to Assess the Safety and Effectiveness of a Fixed-Dose Combination of Pregabalin Prolonged Release and Etoricoxib in Patients with Chronic Low Back Pain with a Neuropathic Component

  • by Sandesh Sahebrao Patil, Brijesh Jerambhai Patel, Bhavsar Neel Mahendrabhai, C. L. Nawal, B. Valya, K. Sanjeev Kumar, Pandurang Wattamwar, Rana Kaushikkumar Ramanlal, Swagat Shah, Mandodari Rajurkar, Supriya Sonowal, Dipak Patil, Pravin Ghadge, Suyog Mehta

  • March 12, 2026

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