Effect of mesalasine in treatment of distal inflammation of intestine.

Combined oral and topical 5-ASA versus topical 5-ASA for the treatment of ulcerative proctitis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201604307080N3

Enrollment

Registered

2016-10-25

Start date

2014-12-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Ulcerative Colitis. Crohn disease of large intestine

Interventions

Intervention 1: Intervention group will be treated with mesalazine suppository500mg twice daily for one year. Intervention 2: Control group will be treated with oral mesalasin 500 mg two tablets thr

Treatment - Drugs

Intervention group will be treated with mesalazine suppository500mg twice daily for one year.

Control group will be treated with oral mesalasin 500 mg two tablets three times daily and mesalasin suppositiry 500mg two times daily for one year.

Eligibility

Sex/Gender

All

Age

15 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Pateints older than 15 years old that have ulcerative colitis upon endoscopic and histologic criteria; severity of disease should be at least 3 of 12. Exclusion criteria: Hypersensitivity to salicilate ; Active PUD; Important liver,renal or heart disease; Patients not respond to 5-ASA and on maintenance therapy with 5-ASA.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Clinical response to each therapy groups. Timepoint: 4 weaks after startin study then every 3 month until 1 year. Method of measurement: Disease Activity Index, Simple Clinical Colitis Activity Index Questianaire.;Endoscopic response to each therapy groups. Timepoint: 4 weaks after startin study then every 3 month until 1 year. Method of measurement: Disease Activity Index, Simple Clinical Colitis Activity Inde Questianaire.;Histopathologic response to each therapy groups. Timepoint: 4 weaks after startin study then every 3 month until 1 year. Method of measurement: Disease Activity Index, Simple Clinical Colitis Activity Index Questianaire.	—

Measure

Time frame

Clinical response to each therapy groups. Timepoint: 4 weaks after startin study then every 3 month until 1 year. Method of measurement: Disease Activity Index, Simple Clinical Colitis Activity Index Questianaire.;Endoscopic response to each therapy groups. Timepoint: 4 weaks after startin study then every 3 month until 1 year. Method of measurement: Disease Activity Index, Simple Clinical Colitis Activity Inde Questianaire.;Histopathologic response to each therapy groups. Timepoint: 4 weaks after startin study then every 3 month until 1 year. Method of measurement: Disease Activity Index, Simple Clinical Colitis Activity Index Questianaire.

—

Secondary

Measure	Time frame
Drug adverse reaction. Timepoint: 4 weaks after starting of study then every 3 month until one yesr. Method of measurement: Questionnaire.;Compliance to each treatment strategy. Timepoint: 4 weaks after starting of study then every 3 month until one yesr. Method of measurement: Questionare.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAida Ghasempour

Babol University of Medical Sciences

Aida_gh1985@yahoo.com+98 11 3199 5926

Outcome results

None listed

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