A Novel Paracetamol 1,000 mg Sustained Release Formulation vs Conventional Paracetamol 500 mg Formulation in Patients with Fever and Pain: A Randomized Noninferiority Trial

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Abstract

Objective.

To compare the efficacy and safety of newly developed paracetamol 1,000 mg sustained release (SR) tablets (test product) with conventional paracetamol 500 mg tablets (reference product) in patients with fever and pain.

Design.

An open label, multicentric, comparative, randomized, noninferiority trial.

Methodology.

Eligible patient, as per predefined inclusion and exclusion criteria, were randomized to receive either one tablet of test product twice daily or one tablet of reference product four times a day for 3 consecutive days. Primary efficacy parameter (an antipyretic activity) was measured through recording changes in body temperature while secondary efficacy parameter (an analgesic activity) was measured by recording changes in visual analog scale (VAS) from the baseline. Safety assessment was done by recording adverse drug reactions occurred during treatment period. Analysis of variance was used for the statistical evaluation of data.

Results.

Of 500 randomized patients, 249 were received paracetamol 1,000 mg SR tablets (Group-I), and 247 were received conventional paracetamol 500 mg tablets (Group-II). Group-I reported temperature reduction from 101.35 ± 1.23°F to 98.80 ± 0.72°F while temperature reduction in Group-II was from 101.42 ± 1.33°F to 98.9 ± 0.85°F. Group-I reported reduction in mean VAS was from 6.16 ± 2.37 to 1.44 ± 1.70 in comparison to Group-II from 5.97 ± 2.45 to 1.38 ± 1.78. No significant adverse reactions were observed in either group.

Conclusion.

Both the formulations of paracetamol were clinically and statically equivalent. Paracetamol 1,000 mg SR formulation is noninferior to conventional paracetamol 500 mg tablets.

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