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.
- 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
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 197
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
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
- Secondary Outcome Measures
Name Time Method