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Clinical Trials/CTRI/2016/01/006545
CTRI/2016/01/006545
Recruiting
Phase 4

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

Cipla Ltd0 sites120 target enrollmentTBD
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ConditionsHealth Condition 1: null- Ulcerative Colitis

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- Ulcerative Colitis
Sponsor
Cipla Ltd
Enrollment
120
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
Cipla Ltd

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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