Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis
PACE
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
2 other identifiers
interventional
107
7 countries
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2014
Typical duration for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2014
CompletedFirst Posted
Study publicly available on registry
March 21, 2014
CompletedStudy Start
First participant enrolled
December 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2018
CompletedResults Posted
Study results publicly available
January 18, 2020
CompletedJune 9, 2021
May 1, 2021
4 years
March 17, 2014
October 16, 2019
May 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Clinical Response During Double-Blind Acute Phase at 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.
Week 8
Number of Participants With Clinical Response During Double-blind Maintenance Phase at 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.
Week 26
Secondary Outcomes (8)
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 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
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
- +3 more secondary outcomes
Study Arms (2)
MMX Mesalamine/Mesalazine (Low Dose)
EXPERIMENTALOnce 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.
MMX Mesalamine/Mesalazine (High Dose)
EXPERIMENTALOnce 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (33)
University of Maryland Children's Hospital
Baltimore, Maryland, 21201, United States
John Hopkins
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Newton Wellesley Hospital
Newton, Massachusetts, 02462, United States
University of Minnesota Children's Hospital
Minneapolis, Minnesota, 55454, United States
Mayo Clinic Gastroenterology
Rochester, Minnesota, 55905, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Texas Digestive Disease Consultants
Southlake, Texas, 76092, United States
Carilion Medical Center
Roanoke, Virginia, 24013, United States
University of Alberta Pediatric Gastroenterology & Nutrition
Edmonton, Alberta, T6G 1C9, Canada
Szent Janos Korhaz És Észak-budai Egyesitett Korha
Budapest, H-1023, Hungary
Bekes Megyei Pandy Kalman Korhaz
Gyula, H-5700, Hungary
Baz Megyei Korhaz Es Egyetemi Oktatokorhaz
Miskolc, 3526, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhaz
Nyíregyháza, 4400, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, H-6720, Hungary
Soroka Medical Center
Beersheba, 85025, Israel
Rambam Health Corporation
Haifa, 31096, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Schneider Medical Centre
Petah Tikva, 49202, Israel
Uniwersytecki Dzieciecy Szpital Kliniczny im. Ludwika Zamenhofa
Bialystok, 15-247, Poland
Klinika Pediatrii Gastroenterologii I Zywienia
Krakow, 30-663, Poland
Klinika Gastroenterologii I Pediatrii
Lodz, 93-338, Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy
Olsztyn, 10-561, Poland
Gabinet Lekarski-Bartosz Korczowski
Rzeszów, 35-302, Poland
Oddzial Gastroenterologii I Hepatologii
Warsaw, 04-730, Poland
Uniwersytecki Szpital Kliniczny We Wrocławiu
Wroclaw, 50-369, Poland
Detská fakultná nemocnica s poliklinikou
Banská Bystrica, 974 09, Slovakia
University Children's Hospital
Bratislava, 833 40, Slovakia
Univerzitna Nemocnica Martin
Martin, 03659, Slovakia
Alder Hey Children's Hospital
Liverpool, LI2 2AP, United Kingdom
Barts Health NHS Trust, Royal London Hospital
London, E1 1BB, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Great Ormond Street Hospital
London, WC1N 3JH, United Kingdom
Related Publications (1)
Croft NM, Korczowski B, Kierkus J, Caballero B, Thakur MK. Safety and efficacy of multimatrix mesalamine in paediatric patients with mild-to-moderate ulcerative colitis: a phase 3, randomised, double-blind study. EClinicalMedicine. 2023 Oct 6;65:102232. doi: 10.1016/j.eclinm.2023.102232. eCollection 2023 Nov.
PMID: 37855022DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Shire Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2014
First Posted
March 21, 2014
Study Start
December 12, 2014
Primary Completion
November 28, 2018
Study Completion
November 28, 2018
Last Updated
June 9, 2021
Results First Posted
January 18, 2020
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.