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.

A Multicenter, Open-label, Single-arm 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. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/04/086055

Enrollment

200

Registered

2025-04-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified

Interventions

Intervention1: FDC of Drotaverine Hydrochloride IP 80 mg and Aceclofenac IP 100 mg Tablet: One Tablet once daily for 1-3 days. Control Intervention1: NOT APPLICABLE: NOT APPLICABLE

Eligibility

Inclusion criteria

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. 3. Diagnosis of the Colicky pain due to smooth muscle spasm/ visceral colic like primary dysmenorrhea, biliary colic and ureteric colic.

Exclusion criteria

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. 9. Hypersensitivity to Drotaverine or Aceclofenac, 10. Fever, 11. Pituitary disease, and 12. Concomitant use of sex hormones except oral contraceptives for which the doses will be unchanged. 13. Any other serious diseases having fatal progression. 14. Any of the following endocrinological diseases: diabetes mellitus, hypo- /hyperthyreosis, pituitary tumor. 15. Clearly kidney or liver disease, abnormal kidney or liver function.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: Baseline, Visit 2 & Visit 3	—

Secondary

Measure	Time frame
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.Timepoint: Baseline, Visit 2 & Visit 3	—

Countries

India

Contacts

Public ContactBadrinath Sangle

Vivotech Research Private Limited

pi@vivotechresearch.com9987598349

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026