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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00767728
Other study ID # MPUC3004
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 2004
Est. completion date October 2007

Study information

Verified date November 2019
Source Bausch Health Americas, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.


Description:

This is a Phase 3 study evaluating the effectiveness and safety of eMG 1.5 g given once daily (QD) compared to placebo in subjects with demonstrated remission from UC. Eligible subjects are randomized in a 2:1 ratio (active:placebo) to receive 1 or 2 treatments: 1.5g eMG (4 capsules total) or matching placebo capsules QD for 6 months.

The study consists of a screening phase (completed within 7 days prior to randomization), a treatment phase (6 months), and a follow-up visit (2 weeks after end-of-study [EOS] visit.) The treatment phase consists of 4 scheduled study visits: visit 1 (baseline/randomization (day 1), visit 2 (month 1), visit 3 (month 3), visit 4 (EOS (month 6).

Primary objective:

To compare the maintenance of remission from mild to moderate ulcerative colitis as measured by rectal bleeding and endoscopic mucosal appearance after 6 months of treatment with encapsulated mesalamine granules (eMG) of 1.5 g QD, as compared with placebo.

Secondary objective:

To compare the safety and tolerability of long-term dosing with eMG at 1.5 g QD as compared to placebo in the maintenance of remission from mild to moderate UC.


Recruitment information / eligibility

Status Completed
Enrollment 256
Est. completion date October 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month

- Greater than 18 years of age

Exclusion Criteria:

- Allergy/intolerance to aspirin, mesalamine, or other salicylates

- Prior bowel surgery other than appendectomy

- Pregnancy, at risk of pregnancy, or lactating

- HIV or hepatitis B or C

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Granulated mesalamine
0.375 g of mesalamine granules were encapsulated in a hard gelatin shell. 1.5 g of eMG (4 capsules) were administered orally QD, in the morning.
Placebo
Matching placebo capsules (4 capsules) were administered orally QD, in the morning.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of subject who were relapse free after 6 months of treatment 6 months
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