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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00326209
Recruitment Status : Completed
First Posted : May 16, 2006
Last Update Posted : December 13, 2017
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

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

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Mesalamine pellets Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 394 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Mesalamine pellets
    subjects receive 4 capsules each morning of 375mg MG each (total of 1.5g QD)

Primary Outcome Measures :
  1. To evaluate the long term safety and tolerability of treatment with mesalamine pellets [ Time Frame: 24 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00326209

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Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Valeant Pharmaceuticals International, Inc. Identifier: NCT00326209     History of Changes
Other Study ID Numbers: MPUC3005
First Posted: May 16, 2006    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Ulcerative colitis
Inflammatory bowel disease

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