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

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00326209
First received: May 12, 2006
Last updated: June 13, 2011
Last verified: June 2011
  Purpose

To evaluate the long-term safety and tolerability of mesalamine pellets (MP)in patients with ulcerative colitis currently in remission.


Condition Intervention Phase
Ulcerative Colitis
Drug: Mesalamine pellets
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet Formulation

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • To evaluate the long term safety and tolerability of treatment with mesalamine pellets [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 394
Study Start Date: December 2005
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Mesalamine pellets
    subjects receive 4 capsules each morning of 375mg MG each (total of 1.5g QD)
Detailed Description:

This is a Phase 3, multicenter, open-label, treatment extension study evaluating the long-term safety and tolerability of encapsulated mesalamine pellets (MP) given QD in subjects who successfully participated in a previous MP study or in subjects who are currently in remission from symptoms of ulcerative colitis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. Subject 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 subjects:

    a. Subject is a male or,

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

    Non-childbearing potential (ie, 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 <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 subject is in a monogamous relationship. The investigator is responsible for determining whether the subject has adequate birth control for study participation.

    b. Subject is ≥18 years of age. c. Subject has historically confirmed diagnosis (physician letter for newly/recently diagnosed and by medical records for previously diagnosed subjects) of mild to moderate UC in remission for >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 (see ; Appendix 2 for a copy of the entire Index).

  3. Subject and investigator consider there is the potential for benefit to the subject with MP treatment.
  4. Subject is capable and willing to comply with all study procedures.

Exclusion Criteria:

  1. 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.

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

  2. Subject has a history of allergy or intolerance to aspirin, mesalamine or other salicylates.
  3. Subject has an abnormal clinical lab result which in the opinion of the investigator is significant enough to prevent subject's enrollment in the study.
  4. Subject or subject's parents are known to have phenylketonuria.
  5. Subject has participated in an investigational drug or device study within the 30 days prior to study screening.
  6. Subject shows evidence of current excessive alcohol consumption or drug dependence.
  7. Subject has uncontrolled, clinically significant renal disease manifested by 1.5 × ULN of serum creatinine or blood urea nitrogen (BUN) levels.
  8. Subject has calculated creatinine clearance level of < 60 mL/min
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326209

  Show 61 Study Locations
Sponsors and Collaborators
Salix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Craig Paterson, MD/VP, Clinical Development, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00326209     History of Changes
Other Study ID Numbers: MPUC3005
Study First Received: May 12, 2006
Last Updated: June 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
UC
Ulcerative colitis
Inflammatory bowel disease
IBD

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Mesalamine
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014