A postmarketing surveillance to study how safe, tolerable, preferred and effective is Mesalo foam (Mesalazine rectal foam 1 gm) in treatment of patients with ulcerative colitis.

A phase IV, observational, prospective, open label, non-comparative, multicentre study to assess the efficacy, preference, safety and tolerability of MESALO Foam (Mesalazine rectal foam 1 gm) in patients with Ulcerative Colitis

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/01/006545

Enrollment

120

Registered

2016-01-20

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: null- Ulcerative Colitis

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects willing to give written, signed & dated informed consent for study participation. 2. Subjects of either gender above 18 years of age. 3. Subjects with established mild Ulcerative Colitis.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to salicylates or any of the excipients. 2. Severe impairment of hepatic or renal function. 3. Pregnant and lactating females. 4. Subjects who are currently participating in any other clinical trial or have participated in any clinical trial in last 30 days of visit 1

Design outcomes

Primary

Measure	Time frame
1. Mean Change in Mayo scores from baseline to weeks 4. 2. Clinical response 3. Clinical remission 4. Acceptance/ preference of the patients with respect to the foam formulation.Timepoint: Throughout the study period.	—

Secondary

Measure	Time frame
1. Incidence and nature of adverse events 2. Incidence of drug related adverse eventsTimepoint: Throughout the study period.	—

Countries

India

Contacts

Public ContactMr Rahul D Namjoshi

Cipla Ltd

abhay.phansalkar@cipla.com022-24814906

Outcome results