To evaluate the safety and effectiveness of Anafortan® syrup (Camylofin Dihydrochloride 12.5 mg plus Paracetamol IP 125 mg) in Indian children presenting with acute colicky i.e. spasmodic abdominal pain.

Phase 4

Completed

• Conditions: Health Condition 1: K529- Noninfective gastroenteritis and colitis, unspecified

• Registration Number: CTRI/2018/10/015902
• Lead Sponsor: Abbott Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-11-14
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 197

Inclusion Criteria

1.Children of either gender aged 8 to12 years

2.Children presenting with acute colicky abdominal pain and having history of at least one episode of acute colicky abdominal pain in the 24-hour period prior to screening

3.Children willing to provide assent and parents/ legal guardian /legally acceptable representative (LAR) willing to give written informed consent for participation of their children

Exclusion Criteria

1.Children with history of taking Anafortan® syrup or any other prescription analgesics and antispasmodics medication (within the previous 1 week before study enrollment).

2.Parents/legal guardian/LAR unwilling or unable to comply with the study procedures and/or make daily diary entries for their children

3.History of hypersensitivity/ allergy to study drug and its constituents

4.Any other illness or conditions that does not justify patientâ??s participation in the study as judged by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the safety of Anafortan® syrup in children with acute colicky abdominal painTimepoint: 5-day course of treatment

Secondary Outcome Measures

Name	Time	Method
To assess the tolerability of Anafortan® syrup in children with acute colicky abdominal painTimepoint: EOT;To determine the effect of Anafortan® syrup on pain intensity for the treatment of children with acute colicky abdominal painTimepoint: 5-day course of treatment;To determine the effect of Anafortan® syrup on the frequency of daily pain episodes over 5-day course of treatmentTimepoint: 5-day course of treatment;To determine the percentage of patients with meaningful pain relief from baseline to end of treatment (EOT)Timepoint: EOT;To determine the physicianâ??s global assessment (PGA) of pain (based on effectiveness and tolerability) at EOTTimepoint: EOT