Skip to main content
Clinical Trials/NCT02093663
NCT02093663CompletedPhase 3

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

Shire33 sites in 7 countries107 target enrollmentStarted: December 12, 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Shire
Enrollment
107
Locations
33
Primary Endpoint
Number of Participants With Clinical Response During Double-Blind Acute Phase at Week 8

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
5 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.
  • Subject's parent/LAR demonstrates an understanding, ability, and willingness to fully comply with study procedures and restrictions.
  • Male and female children and adolescents aged 5-17 years, inclusive.
  • Body weight 18-90kg.
  • 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.
  • 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.
  • Subject is able to swallow the investigational product whole.
  • Double-blind Acute Phase:
  • 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.
  • 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:
  • Partial UC-DAI ≤1 (rectal bleeding=0, stool frequency ≤1, and PGA=0) at the Baseline Visit.

Exclusion Criteria

  • Severe UC (defined by PGA=3).
  • Crohn's disease, bleeding disorders, active peptic ulcer disease, or UC known to be confined to the rectum (isolated rectal proctitis).
  • Asthma, only if known to be 5 ASA sensitive.
  • Positive stool culture for enteric pathogens (including Salmonella, Shigella, Yersinia, Aeromonas, Plesiomonas, or Campylobacter). Clostridium difficile toxin, ova, or parasites present.
  • Systemic or rectal corticosteroid use within 4 weeks prior to the Screening Visit. Topical, intranasal, or inhaled use is not exclusionary.
  • Immunomodulator (6-mercaptopurine, azathioprine) use within 6 weeks prior to the Screening Visit.
  • History of biologic (eg, anti-tumor necrosis factor agents, integrin receptor antagonists) use at any time.
  • Antibiotic use within 7 days prior to the Screening Visit.
  • 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.
  • Prebiotic/probiotic use within 7 days prior to the Screening Visit. Yogurt products are permitted.

Arms & Interventions

MMX Mesalamine/Mesalazine (Low Dose)

Experimental

Once daily, tablets - the amount depends on the participants weight; 900 milligram per day (mg/day) for participants weighing 18 kg to less than or equal to (<=) 23 kilograms (kg); 1200 mg/day for participants weighing greater than (>) 23 kg to <= 35 kg; 1800 mg/day for participants weighing > 35 kg to <= 50 kg; 2400 mg/day for participants weighing > 50 kg to <= 90 kg.

Intervention: MMX Mesalamine/Mesalazine (Low Dose) (Drug)

MMX Mesalamine/Mesalazine (High Dose)

Experimental

Once daily, tablets - the amount depends on the participants weight;1800 mg/day for participants weighing 18 kg to <= 23 kg; 2400 mg/day for participants weighing > 23 kg to <= 35 kg; 3600 mg/day for participants weighing > 35 kg to <= 50 kg; 4800 mg/day for participants weighing > 50 kg to <= 90 kg.

Intervention: MMX Mesalamine/Mesalazine (High Dose) (Drug)

Outcomes

Primary Outcomes

Number of Participants With Clinical Response During Double-Blind Acute Phase at Week 8

Time Frame: Week 8

Clinical response was defined as partial ulcerative colitis disease activity index (UC-DAI) score \< or =1 with rectal bleeding = 0, stool frequency \< or =1, and physician's global assessment (PGA = 0). Number of participants with clinical response were reported.

Number of Participants With Clinical Response During Double-blind Maintenance Phase at Week 26

Time Frame: Week 26

Clinical response was defined as partial UC-DAI \<=1 with (rectal bleeding = 0, stool frequency \< or =1, and PGA = 0). Number of participants who had maintained clinical response were reported.

Secondary Outcomes

  • Number of Participants With Clinical and Endoscopic Response During Double Blind Acute Phase at Week 8 Using Central Reading(Week 8)
  • Number of Participants With Remission at Pediatric Ulcerative Colitis Activity Index (PUCAI) Score During Double-Blind Maintenance Phase at Week 26(Week 26)
  • Number of Participants With Clinical and Endoscopic Response During Double-Blind Maintenance Phase at Week 26 Using Local Reading(Week 26)
  • Number of Participants With Improvement in Pediatric Ulcerative Colitis Activity Index (PUCAI) Score During Double-blind Acute Phase at Week 8(Week 8)
  • Number of Participants With Clinical and Endoscopic Response During Double-Blind Maintenance Phase at Week 26 Using Central Reading(Week 26)
  • Number of Participants With Clinical and Endoscopic Response During Double Blind Acute Phase at Week 8 Using Local Reading(Week 8)
  • Change From Baseline in Daily Ulcerative Colitis Scale (DUCS) Score During Double-Blind Acute Phase(Baseline to Week 8)
  • Change From Baseline in Daily Ulcerative Colitis Scale (DUCS) Score During Double-Blind Maintenance Phase(Baseline, Week 13, and Week 26)

Investigators

Sponsor
Shire
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (33)

Loading locations...

Similar Trials