Abstract :
Background: Spasmodic pain resulting from smooth muscle contraction is a common clinical concern in outpatient department (OPD) as well as in emergency setup. Drotaverine, a phosphodiesterase- 4 inhibitor, is widely used for its antispasmodic properties. A novel drotaverine 40 mg tablet formulation was developed with improved disintegration and dissolution profiles to achieve faster symptomatic relief.Aim and Objective: The objective of this clinical trial was to evaluate and compare the efficacy and safety of two drotaverine tablet formulations in patients experiencing spasmodic pain.Materials and Methods: This prospective, randomized, assessor-blinded, active-controlled, single-center phase IV clinical trial compared the efficacy and safety of advanced drotaverine 40 mg formulation (Indoco Remedies Ltd.) with the conventional formulation in patients aged 18–65 years experiencing acute spasmodic pain due to renal colic, gastrointestinal spasms, or primary dysmenorrhea.Results: A total of 100 patients were randomized equally to receive either formulation, with pain intensity assessed using the Visual Analog Scale (VAS) over a 6-hour observation period. The primary endpoint, Sum of Pain Intensity Difference over 6 hours (SPID-6), showed no significant difference between the test and reference groups (?28.2 ± 2.3 vs. ?26.9 ± 2.3; p = 0.73). However, the test formulation achieved significantly greater mean Pain Intensity Differences (mPID) at 15, 30, 45, and 60 minutes (p < 0.05), indicating faster onset of pain relief. At 6 hours, ?50% pain relief was achieved in 98% (test) and 96% (reference) of patients. Perceived onset of action within 15 and 30 minutes was significantly higher in the test group (22% vs. 8% and 80% vs. 46%, respectively; p < 0.05). Both formulations were well tolerated, with mild adverse events such as nausea, fatigue, and dizziness reported in 7% of patients, and no serious adverse events or discontinuations.Conclusion: While overall pain relief was comparable, the advanced drotaverine formulation provided a faster onset of action, offering a clinical advantage in managing acute spasmodic pain.
Keyword :
Drotaverine, Advanced formulation, Rapid pain relief, Spasmodic pain