A prospective, single-arm, open-label, multi-centric to determine the safety and effectiveness of Anafortan â??N. Fixed-dose combination of Camylofin Dihydrochloride 50mg and Nimesulide 100mg in patients with acute colicky abdominal pain in India

A prospective, single-arm, open-label, multi-centric to determine the safety and effectiveness of Anafortan â??N. Fixed-dose combination of Camylofin Dihydrochloride 50mg and Nimesulide 100mg in patients with acute colicky abdominal pain in India - AHPLIN1701

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/10/016051

Enrollment

294

Registered

2018-10-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: K528- Other specified noninfective gastroenteritis and colitis

Interventions

Intervention1: Camylofin Dihydrochloride: Camylofin Dihydrochloride 50mg -One tablet twice daily for 5 days Intervention2: Nimesulide: Nimesulide 100mg One tablet twice daily for 5 days Control Interv

Eligibility

Inclusion criteria

Inclusion criteria: Male or female patients aged >=18 years to 65 years Patients presenting with acute colicky abdominal pain and having history of at least 1 episode within a 24 hour period prior to screening with no other concomitant illness. Patients willing and able to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with history of taking Anafortan-NÂ® or any other prescription analgesics and antispasmodics medication (within the previous 1 weeks before study enrollment) 2. Pregnant and lactating women 3. History of hypersensitivity/allergy to study drug 4. Cognitive impairment, alcohol abuse, or psychiatric illness that would affect the ability of the patient to complete patient diary and other assessments 5. Any other illness or conditions that does not justify patientâ??s participation in the study as judged by the Investigator 6. Patients not willing to comply with the study procedures

Design outcomes

Primary

Measure	Time frame
To assess the safety of Anafortan-NÂ® in patients with acute colicky abdominal pain.Timepoint: To assess the safety of Anafortan-NÂ® in patients with acute colicky abdominal pain.	—

Secondary

Measure	Time frame
To assess the tolerability of Anafortan-NÂ® in patients with acute colicky abdominal painTimepoint: 5 day course of treatment;To determine the effect of Anafortan-NÂ® tablets on pain intensity for the treatment of patients with acute colicky abdominal painTimepoint: 5 day course of treatment;To determine the effect of Anafortan-NÂ® tablets on the frequency of daily pain episodes over a 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 of pain (based on effectiveness and tolerability) at EOTTimepoint: EOT	—

Measure

Time frame

To assess the tolerability of Anafortan-NÂ® in patients with acute colicky abdominal painTimepoint: 5 day course of treatment;To determine the effect of Anafortan-NÂ® tablets on pain intensity for the treatment of patients with acute colicky abdominal painTimepoint: 5 day course of treatment;To determine the effect of Anafortan-NÂ® tablets on the frequency of daily pain episodes over a 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 of pain (based on effectiveness and tolerability) at EOTTimepoint: EOT

—

Countries

India

Contacts

Public ContactDr Shubhangi Desai

Abbott India Limited

shubhangi.desai@abbott.com2238160918

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026