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Ulcerative ColitisPhase 3PACENCT02093663

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

A Phase 3 study testing MMX Mesalamine/Mesalazine (Low Dose) and MMX Mesalamine/Mesalazine (High Dose) in people with Ulcerative Colitis, run by Shire at 33 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
MMX Mesalamine/Mesalazine (Low Dose) and MMX Mesalamine/Mesalazine (High Dose)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
33 sitesin 7 countries
Study dates
12 Dec 2014to 28 Nov 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

33 sites in 7 countries.

33 sites in 7 countries

United States9 sites

  • University of Maryland Children's Hospital

    Baltimore, Maryland, 21201

  • John Hopkins

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • University of Minnesota Children's Hospital

    Minneapolis, Minnesota, 55454

  • Newton Wellesley Hospital

    Newton, Massachusetts, 02462

  • Carilion Medical Center

    Roanoke, Virginia, 24013

  • Mayo Clinic Gastroenterology

    Rochester, Minnesota, 55905

  • Texas Digestive Disease Consultants

    Southlake, Texas, 76092

Other trials in United States

Poland7 sites

  • Uniwersytecki Dzieciecy Szpital Kliniczny im. Ludwika Zamenhofa

    Bialystok, 15-247

  • Klinika Pediatrii Gastroenterologii I Zywienia

    Krakow, 30-663

  • Klinika Gastroenterologii I Pediatrii

    Lodz, 93-338

  • Wojewodzki Specjalistyczny Szpital Dzieciecy

    Olsztyn, 10-561

  • Gabinet Lekarski-Bartosz Korczowski

    Rzeszów, 35-302

  • Oddzial Gastroenterologii I Hepatologii

    Warsaw, 04-730

  • Uniwersytecki Szpital Kliniczny We Wrocławiu

    Wroclaw, 50-369

Other trials in Poland

Hungary5 sites

  • Szent Janos Korhaz És Észak-budai Egyesitett Korha

    Budapest, H-1023

  • Bekes Megyei Pandy Kalman Korhaz

    Gyula, H-5700

  • Baz Megyei Korhaz Es Egyetemi Oktatokorhaz

    Miskolc, 3526

  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhaz

    Nyíregyháza, 4400

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, H-6720

Other trials in Hungary

Israel4 sites

  • Soroka Medical Center

    Beersheba, 85025

  • Rambam Health Corporation

    Haifa, 31096

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Schneider Medical Centre

    Petah Tikva, 49202

Other trials in Israel

United Kingdom4 sites

  • Alder Hey Children's Hospital

    Liverpool, LI2 2AP

  • Barts Health NHS Trust, Royal London Hospital

    London, E1 1BB

  • King's College Hospital

    London, SE5 9RS

  • Great Ormond Street Hospital

    London, WC1N 3JH

Other trials in United Kingdom

Slovakia3 sites

  • Detská fakultná nemocnica s poliklinikou

    Banská Bystrica, 974 09

  • University Children's Hospital

    Bratislava, 833 40

  • Univerzitna Nemocnica Martin

    Martin, 03659

Other trials in Slovakia

Canada1 site

  • University of Alberta Pediatric Gastroenterology & Nutrition

    Edmonton, Alberta, T6G 1C9

Other trials in Canada

About this study

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

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.

Being tested
MMX Mesalamine/Mesalazine (Low Dose), MMX Mesalamine/Mesalazine (High Dose)
Keywords
Mild, Moderate
Medical subject headings
Colitis, Ulcerative, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MMX Mesalamine/Mesalazine (Low Dose)Drug

    Also called Lialda, Mezavant

    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.

  • MMX Mesalamine/Mesalazine (High Dose)Drug

    Also called Mezavant, Lialda

    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.

Study groups in NCT02093663
Study groupRoleWhat they receive
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.
Receives: Drug: MMX Mesalamine/Mesalazine (Low Dose)
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.
Receives: Drug: MMX Mesalamine/Mesalazine (High Dose)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 8

  2. 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.

    Measured: Week 26

Secondary outcomes (8)

  1. Number of Participants With Clinical and Endoscopic Response During Double Blind Acute Phase at Week 8 Using Central Reading

    Clinical and endoscopic response was defined as UC-DAI <=2 with rectal bleeding = 0 and stool frequency <=1, and PGA = 0, and with mucosal healing (endoscopy score <=1) at least a 1 point reduction in endoscopy score from baseline based on central reading. Participants with missing data at week 8 were assumed not to had a clinical response. Participants who completed week 8 but did not have central reading endoscopies at both baseline and week 8 were excluded. Number of participants with clinical and endoscopic response were reported.

    Measured: Week 8

  2. Number of Participants With Clinical and Endoscopic Response During Double Blind Acute Phase at Week 8 Using Local Reading

    Clinical and endoscopic response was defined as UC-DAI < or =2 with rectal bleeding = 0 and stool frequency < or =1, and PGA = 0, and with mucosal healing (endoscopy score < or =1) at least a 1 point reduction in endoscopy score from baseline based on local reading. Participants with missing data at week 8 were assumed not to had a clinical response. Participants who completed week 8 but did not have local reading endoscopies at both baseline and week 8 were excluded. Number of participants with clinical and endoscopic response were reported.

    Measured: Week 8

  3. Change From Baseline in Daily Ulcerative Colitis Scale (DUCS) Score During Double-Blind Acute Phase

    DUCS score was to measure 7 specific signs or symptom and one impact (abdominal pain, nocturnal stool, daytime stool, blood in stool, diarrhea, urgency, tiredness) of UC with each item score ranged from 0 (worst) to 10 (best) with the overall score ranged from 0 (worst) to 70 (best) based on the responses. Change in the DUCS score from baseline to Week 8 during DBA phase were reported.

    Measured: Baseline to Week 8

  4. Number of Participants With Improvement in Pediatric Ulcerative Colitis Activity Index (PUCAI) Score During Double-blind Acute Phase at Week 8

    PUCAI was a physician-administered measure that focuses on 6 key signs and symptoms of UC and activity limitations producing a total score ranging from 0-85 with higher scores being worse. Recommended cut-off scores to differentiate disease activity are < 10 (remission); 11-30 (mild); 31-64 (moderate) and > 65 (severe). Participants with an improvement (change of greater than or equal to [> or =] 20 points) in PUCAI score. Number of participants with improvement in PUCAI score during Double-blind Acute Phase at Week 8 were reported.

    Measured: Week 8

  5. Number of Participants With Clinical and Endoscopic Response During Double-Blind Maintenance Phase at Week 26 Using Central Reading

    Clinical and endoscopic response was defined as UC-DAI < or =2 with rectal bleeding=0, stool frequency < or =1, PGA=0, and with mucosal healing (endoscopy score < or =1) based on central reading at Week 26. Number of participants with clinical and endoscopic response during double-blind maintenance phase at Week 26 using central reading were reported.

    Measured: Week 26

  6. Number of Participants With Clinical and Endoscopic Response During Double-Blind Maintenance Phase at Week 26 Using Local Reading

    Clinical and endoscopic response was defined as UC-DAI < or = 2 with rectal bleeding=0, stool frequency < or = 1, PGA=0, and with mucosal healing (endoscopy score < or = 1) based on local reading. Number of participants who had maintained clinical and endoscopic response during double-blind maintenance phase at week 26 using local reading were reported.

    Measured: Week 26

  7. Change From Baseline in Daily Ulcerative Colitis Scale (DUCS) Score During Double-Blind Maintenance Phase

    DUCS score was to measure 7 specific signs or symptom and one impact (abdominal pain, nocturnal stool, daytime stool, blood in stool, diarrhea, urgency, tiredness) of UC with each score range from 0 (worst) to 10 (best) with the overall score ranging from 0 (worst) to 70 (best) based on the responses. Change from Baseline in DUCS score during double-blind maintenance phase at week 13 and Week 26 wwere reported.

    Measured: Baseline, Week 13, and Week 26

  8. Number of Participants With Remission at Pediatric Ulcerative Colitis Activity Index (PUCAI) Score During Double-Blind Maintenance Phase at Week 26

    PUCAI was a physician-administered measure that focuses on 6 key signs and symptoms of UC and activity limitations producing a total score ranging from 0-85 with higher scores being worse. Recommended cut-off scores to differentiate disease activity are < 10 (remission); 11-30 (mild); 31-64 (moderate) and > 65 (severe). Number of participants with remission at PUCAI score during double-blind maintenance phase at week 26 were reported.

    Measured: Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2014 (estimated)
  2. Study start12 Dec 2014
  3. Primary completion28 Nov 2018
  4. Study completion28 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02093663
Sponsor's protocol ID
SPD476-319
Other IDs
2013-001744-65
Acronym
PACE
Status last verified
May 2021
First submitted
17 Mar 2014
Last updated
9 Jun 2021
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37855022

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MMX Mesalamine/Mesalazine (Low Dose) and MMX Mesalamine/Mesalazine (High Dose) in people with Ulcerative Colitis, run by Shire at 33 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Poland, Hungary, Israel, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinical Response During Double-Blind Acute Phase at Week 8 (time frame: Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02093663, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.

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