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 - Summary - 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

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Objective:

To evaluate the safety and efficacy of a fixed-dose combination of prolonged release pregabalin and etoricoxib in patients with chronic low back pain featuring neuropathic symptoms.

Key Findings:
  • The fixed-dose combination was well tolerated with only 7.18% of patients experiencing mild or moderate adverse effects.
  • Patients reported significant pain relief and improved daily functioning over the 8-week treatment period.
  • The need for additional 'rescue' medication decreased, indicating improved pain control.
Interpretation:

The combination of pregabalin and etoricoxib effectively addresses both neuropathic and nociceptive pain components in chronic low back pain, showing promise for clinical use.

Limitations:
  • Single-arm study design limits comparison with control groups.
  • Results may not be generalizable beyond the specific patient population studied.
Conclusion:

The fixed-dose combination of pregabalin and etoricoxib is a promising treatment option for chronic low back pain with neuropathic features, demonstrating safety and efficacy in a real-world setting.

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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