New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00269438
• Date of registration: 22/12/2005
• Prospective Registration: No
• Primary sponsor: Bausch Health Americas, Inc.
• Public title: New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis
• Scientific title: Phase 3 Study to Establish the Efficacy and Safety of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium Dosed Twice Daily in Achieving Clinical Improvement in Subjects With Mildly to Moderately Active Ulcerative Colitis After 8 Weeks of Therapy
• Date of first enrolment: December 2005
• Target sample size: 225
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00269438
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Double.
• Phase: Phase 3

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

A subject will be eligible for inclusion in this study only if all of the following
criteria apply:

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

2. Subject is a male or, if the subject is female, she is eligible to enter if she is of:

Non-childbearing potential (i.e. 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:

- Double barrier method of contraception, specifically, use of a condom and
spermicide, for 1 week prior to study drug administration, throughout the 8 week
Treatment Phase.

- 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.

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

- 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

- Partner has undergone vasectomy and subject is in a monogamous relationship. The
investigator is responsible for determining whether the subject is using
appropriate birth control for study participation.

- Subject is greater than or equal to 18 years of age.

- Subjects with mildly to moderately active ulcerative colitis experiencing
symptoms of an acute flare within the past 4 weeks.

3. Subject has not taken more than 2.4 grams of mesalamine or equivalent for a continuous
period of 4 weeks preceding the screening visit

4. Subjects must have a baseline Modified Mayo Disease Activity Index (MMDAI) score
between 6 and 10, inclusive. Additionally, subjects must score greater than or equal
to 2 on Bleeding and greater than or equal to 2 on Endoscopy/Sigmoidoscopy.

5. Subject is capable and willing to comply with all study procedures.

6. Disease extends at least 20 cm from the rectum on screening sigmoidoscopy.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria
apply (Note: Development of any of the following exclusion criteria on-study will be
considered a basis for subject discontinuation.):

1. Subject has a significant medical, including psychiatric, condition which in the
opinion of the investigator precludes participation in the study.

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

3. Subject has recently (within the past 30 days) failed therapy with balsalazide
disodium

4. Subject has received immunosuppressive therapy (e.g. azothioprine, 6 mercaptopurine)
within 30 days, or corticosteroids (oral, intravenous [IV] or topical rectal) within
30 days prior to screening.

5. Subject has received intra-rectal aminosalicylates within 14 days of screening.

6. Subject has had any prior bowel surgery, excepting appendectomy.

7. Subject has participated in an investigational drug or device study within the 30 days
prior to study screening, with the exception of Salix protocols 3003 & 3004 entitled:
"A multicenter, randomized, double-blind, placebo controlled trial to evaluate the use
of mesalamine pellet formulation 1.5G QD to maintain remission from mildly to moderate
ulcerative colitis."

8. Subject is pregnant or at risk of pregnancy, or is lactating (female subjects only).

9. Subject shows evidence of current excessive alcohol consumption or drug dependence.

10. Subject has a history of human immunodeficiency virus (HIV) or hepatitis (B and C).

11. Subject has other infectious, ischemic, or immunologic diseases with GI involvement.

12. Subject has twice the upper limit of normal (ULN) for any of the following LFTs:
alanine aminotransferase (ALT/SGPT), aspartate aminotransferase (AST/SGOT), alkaline
phosphatase, or total bilirubin (except isolated elevation of unconjugated bilirubin).

13. Subject has uncontrolled, clinically significant renal disease manifested by 1.5 × ULN
of serum creatinine or blood urea nitrogen (BUN) levels.

14. Subject has calculated creatinine clearance level of less than or equal to 60 mL/min.

15. Subject has unstable cardiovascular, coagulopathy or pulmonary disease.

16. Subject has active malignancy within the last 5 years, except basal cell carcinoma of
the skin, or if female, in situ cervical carcinoma that has been surgically excised.

17. Subject 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.

18. Subject has sclerosing cholangitis.

19. Subject has positive stool culture for ovum and parasites (O and P) or C. difficile.

20. Subject has been treated with infliximab, cyclosporine, natalizumab, or methotrexate
for ulcerative colitis within the last 30 days prior to screening.

21. Regular use of NSAIDS except cardioprotective ASA (i.e., less than or equal to 162 mg
ASA per day).

22. Subject has received cell-depleting therapies such as the Adacolumn.

23. Subject requires antidiarrheal therapy during screening.

24. Subject has clinical or radiographic findings suggestive of serious UC complications
such as toxic megacolon or colonic perforation.

Females of Reproductive Potential:

If a female subject becomes pregnant while on this study, the study drug will be
discontinued immediately and the subject followed until the outcome of the pregnancy is
known. If a pregnancy occurs, it will be reported in the


Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: 5 ASA, enemas, suppositories, corticosteroids

Primary Outcome(s)

Proportion of subjects that achieve clinical improvement and improvement in the rectal bleeding subscale of the MMDAI at the end of eight weeks of therapy, where clinical improvement is defined as a >3 point improvement from baseline in the MMDAI.

Secondary Outcome(s)

The change from baseline over the duration of treatment in total MMDAI score and in the individual MMDAI subscales.

Secondary ID(s)

BZUC3002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors