Post Marketing Surveillance study of the Fixed-dose combination tablets of Drotaverine 80 mg and Aceclofenac 100 mg in patients with Colicky pain due to smooth muscle spasm.

Not Applicable

Recruiting

Conditions: Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,

Brief Summary: This **Multicenter, Open-label, Single-arm Post-Marketing Surveillance (PMS) study** evaluates the **Fixed-Dose Combination (FDC) of Drotaverine 80 mg and Aceclofenac 100 mg** in patients with **colicky pain due to smooth muscle spasm**. Patients will receive **one tablet once daily for 2-3 days**, with assessments conducted at screening, enrollment, and end-of-study visits. The **primary objective** is to assess the **safety profile**, while the **secondary objective** is to evaluate the **efficacy** of the combination therapy. Key endpoints include **adverse event incidence**, **quality of life changes**, **pain severity reduction**, and **Physician’s Global Assessment** of treatment response.

Recruitment & Eligibility

Inclusion Criteria

Subjects meeting following criteria will be included in the study: 1.
All patients with duly filled in ICFs [Informed Consent Forms] 2.
18-45 years of age.
Diagnosis of the Colicky pain due to smooth muscle spasm/ visceral colic like primary dysmenorrhea, biliary colic and ureteric colic.

Exclusion Criteria

Subjects will be excluded from the study for any of the following reasons: 1.
Patients unwilling to sign on ICF 2.
Participation in other trials, 3.
Concomitant therapy, 4.
Pregnancy or breast feeding, 5.
Inadequate contraception, 6.
Dementia, 7.
Alcohol or drug dependence, 8.
Concomitant serious medical condition.
Hypersensitivity to Drotaverine or Aceclofenac, 10.
Pituitary disease, and 12.
Concomitant use of sex hormones except oral contraceptives for which the doses will be unchanged.
Any other serious diseases having fatal progression.
Any of the following endocrinological diseases: diabetes mellitus, hypo- /hyperthyreosis, pituitary tumor.
Clearly kidney or liver disease, abnormal kidney or liver function.

Primary Outcome Measures

Name	Time	Method
To assess the safety profile of Fixed-dose combination tablets of Drotaverine 80 mg and Aceclofenac 100 mg in patients with Colicky pain due to smooth muscle spasm.	Baseline, Visit 2 & Visit 3

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy profile of Fixed-dose combination tablets of Drotaverine 80 mg and Aceclofenac 100 mg in patients with Colicky pain due to smooth muscle spasm.	Baseline, Visit 2 & Visit 3

Locations (3): Ashirwad Hospital and Research Centre,
🇮🇳
Thane, MAHARASHTRA, India
Supe Heart And Diabetes Hospital & Research Centre
🇮🇳
Nashik, MAHARASHTRA, India
Swastik Dhadiwal Hospital
🇮🇳
Nashik, MAHARASHTRA, India
Ashirwad Hospital and Research Centre,
🇮🇳Thane, MAHARASHTRA, India
Dr Shrikant Vishnu Deshpande
Principal investigator
9822017445
writetoshrikant@rediffmail.com