Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00326209
• Date of registration: 12/05/2006
• Prospective Registration: No
• Primary sponsor: Bausch Health Americas, Inc.
• Public title: Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission
• Scientific title: A Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet Formulation
• Date of first enrolment: December 22, 2005
• Target sample size: 393
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00326209
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Lindsey Mathew
• Affiliation: Bausch Health Americas, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. An Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent is
signed and dated prior to any study-related activities.

2. Participant has successfully participated in a previous MP clinical study per
investigator's discretion with successful participation minimally defined as compliant
with study-related procedures and study drug dosing schedule in the previous study and
did not discontinue from the previous study due to study drug-related AE(s) or if new
participants:

a. Participant is a male or,

If the participant is female, she is eligible to enter if she is of:

Non-childbearing potential (that is; physiologically incapable of becoming pregnant,
including any female who has undergone sterilization [hysterectomy or bilateral tubal
ligation] or is post-menopausal. For purposes of this study, postmenopausal is defined
as 1 year without menses); or childbearing potential, has a negative serum pregnancy
test at screen and, if heterosexually active, agrees to one of the following:

i) Double barrier method of contraception, specifically, use of a condom and
spermicide, for 1 week prior to study drug administration, throughout the 6-month
Treatment Phase, and the 2-week follow-up phase.

ii) Oral contraceptives administered for at least 2 monthly cycles prior to study drug
administration during all 6 months of study drug administration and administered for 1
monthly cycle following completion of the study.

iii) An intrauterine device (IUD), inserted by a qualified clinician, with published
data showing that the lowest expected failure rate is less than (<)1% per year (not
all IUDs meet this criterion).

iv) Medroxyprogesterone acetate (DEPO-PROVERA) administered for a minimum of 1 monthly
cycle prior to the study drug administration, during all 6 months of study drug
administration, and administered for 1 monthly cycle following study completion.
Norelgestromin/ ethinyl estradiol transdermal system (Ortho Evra patch) administered
for at least 2 monthly cycles prior to study drug administration and administered for
2 monthly cycles following study completion.

v) Partner has undergone vasectomy and participant is in a monogamous relationship.

The investigator is responsible for determining whether the participant has adequate
birth control for study participation.

b. Participant is greater than or equal to (=) 18 years of age. c. Participant has
historically confirmed diagnosis (physician letter for newly/recently diagnosed and by
medical records for previously diagnosed participants) of mild to moderate UC in
remission for greater than (>) 1 month and <12 months.

d. Confirmed current remission defined as both: A screening rectal bleeding score of 0
as described in the Disease Activity Index (DAI) (Sutherland Index) where 0 = None A
screening sigmoidoscopy score of 0 to 1 for mucosal appearance as described in the
(Sutherland Index where 0 = intact mucosa with preserved or distorted vessels and 1 =
Erythema, decreased vascular pattern, granularity, no mucosal hemorrhage.

3. Participant and investigator consider there is the potential for benefit to the
participant with MP treatment.

4. Participant is capable and willing to comply with all study procedures.

Exclusion Criteria:

1. Participant has any condition or circumstance that would, in the opinion of the
investigator, prevent completion of the study or interfere with analysis of study
results, including history of noncompliance with treatments or visits.

If a new participant, the following additional exclusion criteria will apply:

2. Participant has a history of allergy or intolerance to aspirin, mesalamine or other
salicylates.

3. Participant has an abnormal clinical lab result which in the opinion of the
investigator is significant enough to prevent participant's enrollment in the study.

4. Participant or participant's parents are known to have phenylketonuria.

5. Participant has participated in an investigational drug or device study within the 30
days prior to study screening.

6. Participant shows evidence of current excessive alcohol consumption or drug
dependence.

7. Participant has uncontrolled, clinically significant renal disease manifested by 1.5 *
ULN of serum creatinine or blood urea nitrogen (BUN) levels.

8. Participant has calculated creatinine clearance level of <60 mL/min



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Encapsulated Mesalamine Granules (eMG)

Primary Outcome(s)

Number of Participants Who Prematurely Discontinued Treatment [Time Frame: Baseline up to Month 24]

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Baseline (Day 1) up to follow-up (24.5 months)]

Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities [Time Frame: Baseline up to follow-up (24.5 months)]

Number of Participants With Clinically Significant Change From Baseline in Vital Signs [Time Frame: Baseline, up to follow-up visit (Month 24.5)]

Secondary ID(s)

MPUC3005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/11/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00326209