Trial record 49 of 88 for:    gastroenterology | Recruiting | Exclude Unknown | United States

Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis (PACE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Shire
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT02093663
First received: March 17, 2014
Last updated: May 4, 2016
Last verified: May 2016
  Purpose
To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.

Condition Intervention Phase
Ulcerative Colitis
Drug: MMX Mesalamine/Mesalazine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis, in Both Acute and Maintenance Phases

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Clinical Response [ Time Frame: 8 weeks (Acute Phase) ] [ Designated as safety issue: No ]
    Partial Ulcerative Colitis Disease Activity Index (UC-DAI) Score. This assessment was done without endoscopy.

  • Maintenance of Clinical Response [ Time Frame: 26 weeks (Maintenance Phase) ] [ Designated as safety issue: No ]
    Partial Ulcerative Colitis Disease Activity Index (UC-DAI) Score. This assessment was done without endoscopy.


Secondary Outcome Measures:
  • Clinical and Endoscopic Response [ Time Frame: 8 weeks (Acute Phase) and 26 weeks (Maintenance Phase) ] [ Designated as safety issue: No ]
    Full UC-DAI Score. This assessment was done with endoscopy.

  • Changes in Signs and Symptoms of Mild to Moderate Ulcerative Colitis [ Time Frame: 8 weeks (Acute Phase) and 26 weeks (Maintenance Phase) ] [ Designated as safety issue: No ]
    Daily Ulcerative Colitis Scale (DUCS) Score.

  • Improvement in Mild to Moderate Ulcerative Colitis [ Time Frame: 8 weeks (Acute Phase) ] [ Designated as safety issue: No ]
    Pediatric Ulcerative Colitis Activity Index (PUCAI) Score

  • Remission [ Time Frame: 26 weeks (Maintenance Phase) ] [ Designated as safety issue: No ]
    PUCAI


Estimated Enrollment: 160
Study Start Date: April 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MMX Mesalamine/Mesalazine (Low Dose)

Once daily, tablets - the amount depends on the subjects weight

  • 900 mg/day for subjects weighing 18 to less than or equal to 23kg
  • 1200 mg/day for subjects weighing >23 to less than or equal to35kg
  • 1800 mg/day for subjects weighing >35 to less than or equal to 50kg
  • 2400 mg/day for subjects weighing >50 to less than or equal to 90kg.
Drug: MMX Mesalamine/Mesalazine
Other Names:
  • Lialda
  • Mezavant
Experimental: MMX Mesalamine/Mesalazine (High Dose)

Once daily, tablets - the amount depends on the subjects weight

  • 1800 mg/day for subjects weighing 18 to less than or equal to 23kg
  • 2400 mg/day for subjects weighing >23 to less than or equal to35kg
  • 3600 mg/day for subjects weighing >35 to less than or equal to 50kg
  • 4800 mg/day for subjects weighing >50 to less than or equal to 90kg.
Drug: MMX Mesalamine/Mesalazine
Other Names:
  • Lialda
  • Mezavant

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to voluntarily provide written, signed, and dated (personally or via a legally authorized representative [LAR]) informed consent or assent as applicable to participate in the study.
  2. Subject's parent/LAR demonstrates an understanding, ability, and willingness to fully comply with study procedures and restrictions.
  3. Male and female children and adolescents aged 5-17 years, inclusive.
  4. Body weight 18-90kg.
  5. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.
  6. Diagnosed with mild to moderate UC, established by sigmoidoscopy or colonoscopy with compatible histology. Screened subjects may also have an unconfirmed diagnosis of mild to moderate UC; however the diagnosis of mild to moderate UC must have been established by sigmoidoscopy or colonoscopy with compatible histology prior to baseline visit.
  7. Subject is able to swallow the investigational product whole.

    Double-blind Acute Phase:

  8. Partial UC-DAI score ≥2 (a combined rectal bleeding and stool frequency score ≥1 and PGA=1 or 2) at the Baseline Visit, for which 5-ASA would be used as part of normal treatment.
  9. If the subject is on 5-ASA treatment prior to study entry, then the dose must be stable. Stable therapy is defined as no change in dose, or no initiation of 5-ASA, from the onset of the current acute flare through discontinuation of therapy (required at the Baseline Visit).

    Double-blind Maintenance Phase:

  10. Partial UC-DAI ≤1 (rectal bleeding=0, stool frequency ≤1, and PGA=0) at the Baseline Visit.

Exclusion Criteria:

  1. Severe UC (defined by PGA=3).
  2. Crohn's disease, bleeding disorders, active peptic ulcer disease, or UC known to be confined to the rectum (isolated rectal proctitis).
  3. Asthma, only if known to be 5 ASA sensitive.
  4. Positive stool culture for enteric pathogens (including Salmonella, Shigella, Yersinia, Aeromonas, Plesiomonas, or Campylobacter). Clostridium difficile toxin, ova, or parasites present.
  5. Systemic or rectal corticosteroid use within 4 weeks prior to the Screening Visit. Topical, intranasal, or inhaled use is not exclusionary.
  6. Immunomodulator (6-mercaptopurine, azathioprine) use within 6 weeks prior to the Screening Visit.
  7. History of biologic (eg, anti-tumor necrosis factor agents, integrin receptor antagonists) use at any time.
  8. Antibiotic use within 7 days prior to the Screening Visit.
  9. Any anti-inflammatory drugs, not including 5-ASA treatment but including non-steroidal anti-inflammatory drugs such as aspirin, COX-2 inhibitors or ibuprofen, within 7 days prior to the Screening Visit unless used at over-the-counter levels for <3 days. However, prophylactic use of a stable dose of aspirin up to 325mg/day for cardiac disease is permitted.
  10. Prebiotic/probiotic use within 7 days prior to the Screening Visit. Yogurt products are permitted.
  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: NCT02093663

Contacts
Contact: Shire Contact clinicaltransparency@shire.com

  Show 35 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Shire Physician Shire
  More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02093663     History of Changes
Other Study ID Numbers: SPD476-319  2013-001744-65 
Study First Received: March 17, 2014
Last Updated: May 4, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
Mild
Moderate

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
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 25, 2016