Efficacy, Safety, and Tolerability of a Fixed-Dose Combination of Camylofin and Diclofenac in the Management of Moderate-to- Severe Colic: A Phase IV Clinical Study

Abstract

Background: Colic is a common cause of severe abdominal pain, often requiring pharmacological intervention for symptom relief. Traditional treatment approaches include non-steroidal anti-inflammatory drugs and antispasmodics, but their standalone efficacy varies. This study evaluates the safety, tolerability, and efficacy of a fixed-dose combination (FDC) of camylofin dihydrochloride (50 mg) and diclofenac potassium (50 mg) in managing moderate-to-severe colic.

Objective: The objective of the study was to assess the safety, tolerability, and efficacy of camylofin-diclofenac FDC in adult patients with moderate-to-severe colic.

Methods: This open-label, multicentric, non-comparative, observational Phase IV study enrolled 200 adults with confirmed colic across four clinical sites. Participants received camylofin-diclofenac twice daily for 5 days. Primary endpoints included safety and tolerability assessments based on reported adverse events (AEs) and laboratory abnormalities. Secondary efficacy outcomes were evaluated using the clinical global impression scale, severity of illness scores, and efficacy index.

Results: Of the 200 participants, 191 completed the study. The most commonly reported AEs were mild gastritis (5%) and dizziness (2%), with no severe adverse effects recorded. Severity of illness scores significantly improved from baseline (4.23 ± 1.20) to day 3 (2.87 ± 0.86, P < 0.0001) and day 5 (1.65 ± 0.81, P < 0.0001). Global improvement and efficacy index scores also demonstrated significant reductions, supporting the FDC’s effectiveness.

Conclusion: Camylofin-diclofenac FDC was well tolerated and effective in reducing colic severity. Its dual mechanism of smooth muscle
relaxation and anti-inflammatory action makes it a promising therapeutic option for colic management.