Ulcerative ColitisPhase 3NCT02522767
Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)
A Phase 3 study testing Mesalamine in people with Ulcerative Colitis, run by Ferring Pharmaceuticals at 93 sites in 11 countries.
Trial summary
The purpose of this trial is to investigate the efficacy of mesalamine for the induction of clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will receive 4 g extended release granules (sachet) once daily. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Mesalamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 93 sitesin 11 countries
- Study dates
- Oct 2015to 3 Apr 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 to 75 years
- Mild to moderate UC
Who cannot join
- Disease limited to proctitis <15 cm
- Short bowel syndrome
- Prior colon resection surgery
- History of severe/fulminant UC
- Evidence of other forms of inflammatory bowel disease
- Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV])
Show all 11Show fewer
- Intolerant or allergic to aspirin or salicylate derivatives
- Use of rectal formulations (5-aminosalicylic acid [5-ASA], steroids) within ≤7 days
- Women who are pregnant or nursing
- History or known malignancy
- History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/emotional disorders, that would interfere with their participation in the trial
Trial locations and contacts
93 sites in 11 countries.
93 sites in 11 countries
Ukraine20 sites
Regional Municipal Institution Chernivtsi Regional Clinical Hospital
Chernivtsi
Municipal Institution Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov
Dnipropetrovsk
Municipal Healthcare Institution Kharkiv City Clinical Hospital #2
Kharkiv
SI National Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine
Kharkiv
Municipal Intitution "Kherson City Clinical Hospital n.a. A. and O. Tropinykh"
Kherson
Private Enterprise Private Manufactire Company "Acinus".
Kirovohrad
Kremenchuk city Hospital # n.a O.T.Bohaievskyi
Kremenchuk
Kyiv Municipal Clinical Hospital #18
Kyiv, Kyïv
Medical Center LLC Ukrainian German Antiulcer Gastroenterology Center BIK Kyiv
Kyiv, Kyïv
Kyiv City Clinical Hospital #8
Kyiv
Kyiv Municipal Clinical Hospital #18
Kyiv
Medical Center Universal Clinic Oberih of LLC Kapytal
Kyiv
Municipal City Clinical emergency Hospital
Lviv
Municipal Institution Odesa Regional Clinical Hospital
Odesa
Medical Clinical Research Center of Medical Center LLC Health Clinic
Vinnytsia
Small Business Private Enterprise Medical Center "Pulse"
Vinnytsia
Vinnytsia Regional Clinical Hospital Hospital n.a. M.I. Pyrohov
Vinnytsia
Municipal Institution 6th City Clinical Hospital of Zaporizhzhia City Council
Zaporizhzhya
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
Zaporizhzhya
Medical Centre of PE First Private Clinic
Zhytomyr
United States18 sites
New River Valley Research Institute
Christiansburg, Virginia
Cumberland Research Associates, LLC
Fayetteville, North Carolina
Associates in Gastroenterology, PLC
Hermitage, Tennessee, 37076
BI Research Center
Houston, Texas
Biopharma Informatic Inc.
Houston, Texas
Clinical Trials of SWLA, LLC
Lake Charles, Louisiana
Preferred Research Partners
Little Rock, Arkansas
Research Associates of South Florida, LLC
Miami, Florida
United Research Institute
Murrieta, California
Quality Medical Research, PLLC
Nashville, Tennessee
Digestive & Liver Disease Specialists
Norfolk, Virginia
Advanced Research Institute
Ogden, Utah
IMIC
Palmetto Bay, Florida
Digestive Health Center
Pasadena, Texas
Medical Research Center of Florida
Pembroke Pines, Florida
Lenus Research and Medical Group
Sweetwater, Florida
DM Clinical Research
Tomball, Texas
Wilmington Gastroenterology Associates
Wilmington, North Carolina
Russia13 sites
Regional Clinical Hospital
Krasnoyarsk
City Clinical Hospital #51
Moscow
Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
Nizhny Novgorod
Novosibirsk State Medical University
Novosibirsk
Research Institute of Physiology of Sibirian Branch the RAMS
Novosibirsk
Omsk State Medical Academy
Omsk
Rostov State Medical University
Rostov-on-Don
State Budget Institution of Ryazan region" Regional Clinical Hospital"
Ryazan
City Hospital #31
Saint Petersburg
City Polyclinic #38
Saint Petersburg
Russian Medical Military Academy n.a. S.M. Kirov
Saint Petersburg
Railway Clinical Hospital at Station Samara OAO Rzhd
Samara
Stavropol State Medical Academy
Stavropol
Poland12 sites
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship
Niepubliczny Zaklad Opieki Zdrowotnej Intermed
Częstochowa
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship
Economicus - NZOZ ALL-MEDICUS
Katowice
Investigational site
Ksawerów
Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
Lodz
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz
Osrodek Medycyny Rodzinnej Sp. z o.o.
Sobótka, Lower Silesian Voivodeship
Investigational site
Sopot
Zespół Przychodni Specjalistycznych PRIMA Sp. z o.o.
Warsaw, Masovian Voivodeship
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warsaw
Lexmedica
Wroclaw, Lower Silesian Voivodeship
Bulgaria8 sites
Multiprofile Hospital For Active Treatment Avis Medica
Pleven
Medical Center Excelsior OOD
Sevlievo
Medical Center-1-Sevlievo EOOD
Sevlievo
City Clinic University Multiprofile Hospital for Active Treatment EOOD
Sofia
Medical Center Asklepion - Humane Medicine Research EOOD
Sofia
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
Sofia
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia
Diagnostic Consultative Centre Mladost M OOD
Varna
Hungary7 sites
Magyar Honvédség Egészségügyi Központ
Budapest
Pannónia Magánorvosi Centrum Kft
Budapest
Semmelweis Egyetem Institute
Budapest
Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja
Debrecen
ENDOMEDIX Kft.
Miskolc
Karolina Korhaz Rendelointezet
Mosonmagyaróvár
Clinfan Kft.
Szekszárd
Latvia5 sites
Polana-D, LTD
Daugavpils
Digestive Diseases Centre Gastro
Riga
Latvian Maritime Medicine Centre
Riga
Pauls Stradins Clinical University Hospital
Riga
Riga East Clinical University Hospital
Riga
Mexico3 sites
ICARO Investigaciones en Medicina, S.A de C.V
Chihuahua City
Maria Auxiliadora Hospital
Guadalajara
Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V.
Zapopan
Switzerland3 sites
Inselspital Bern
Bern
Investigational site
Bern
Universitätsspital Zürich
Zurich
Canada2 sites
Topstone Research Institute
Ottawa, Ontario
Toronto Digestive Disease Associates
Vaughan
Serbia2 sites
Clinical Hospital Centar Zvezdara
Belgrade
Health Center Valjevo
Valjevo
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis
The purpose of this trial is to investigate the efficacy of mesalamine for the induction of clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will receive 4 g extended release granules (sachet) once daily.
- Conditions
- Ulcerative Colitis
- Being tested
- Mesalamine, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesalamineDrug
Also called Mesalazine, Pentasa
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Mesalamine | Experimental | 4 g extended release granules (sachet) Receives: Drug: Mesalamine |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With Remission
The proportion of subjects with remission was defined by the Clinical and Endoscopic Response Score: 0 for rectal bleeding; 0 or 1 with at least 1 point decrease from baseline for stool frequency; 0 or 1 for endoscopic score.
The Clinical and Endoscopic Response Score ranged between 0-9, higher scores indicating greater disease severity. This score had two components: Clinical Response which assessed subject's symptoms and ranged between 0-6, and Endoscopic Response which assessed objective evidence of inflammation and ranged between 0-3.
Further, the Clinical Response component included two subscales: stool frequency and rectal bleeding (each ranged between 0-3 each) obtained from subjects' daily records. The Endoscopic Response component had one subscale: flexible sigmoidoscopy/colonoscopy (ranging between 0-3).
Measured: At Week 8
Secondary outcomes (14)
Proportion of Subjects With Remission in the Primary Endpoint and the Physician's Global Assessment (PGA) Score of ≤1 (Modified Mayo Score)
The Modified Mayo score was calculated as the sum of the Clinical and Endoscopic Response Score (Range: 0-9, and the standard PGA score (range: 0-3; normal [score=0], mild disease [score=1], moderate disease [score=2], severe disease [score=3]).
The statistical test was to be conducted only if the primary analysis was significant.
Measured: At Week 8
Time to Cessation of Rectal Bleeding
Defined as time in days from randomization to the first day of 3 consecutive days with a rectal bleeding score of 0, based on subject's daily diary.
The statistical test was to be conducted only if the primary analysis was significant.
Measured: Up to Week 8
The Proportion of Subjects With Endoscopic Improvement
Defined as an Endoscopic Response Score of 0 or 1, with at least a 1 point reduction from baseline in the endoscopic score at Week 8.
Measured: At Week 8
The Proportion of Subjects in Clinical Remission at Weeks 2, 4, and 8
Defined as a score of 0 for rectal bleeding and 0 or 1 with at least 1 point decrease from baseline for stool frequency in the Clinical Response Score subset.
Measured: At Week 2, 4, and 8
Time to Normal Stool Pattern
Defined as time in days from randomization to the first day of 3 consecutive days with a stool frequency score of 0, based on subject daily diary.
Measured: Up to Week 8
The Change From Baseline in Rectal Bleeding Score at Weeks 2, 4, and 8
Defined as change from baseline in rectal bleeding score at Week 2, 4, and 8 based on subject daily diary. Rectal Bleeding Score is graded 0-3, where 0 is best.
Measured: From baseline to Week 2, 4, and 8
The Change From Baseline in Serum C-reactive Protein (CRP) Levels at Weeks 2, 4, and 8
The adjusted mean changes in serum CRP levels from baseline and their difference between treatment groups are presented for each time point.
Measured: From baseline to Week 2, 4, and 8
The Change From Baseline in Fecal Calprotectin Levels at Week 8
The adjusted mean change from baseline in fecal calprotectin levels at Week 8 are presented.
Measured: From baseline to Week 8
The Change From Baseline in Health Related Quality of Life (QoL) Scores
The change from baseline to Week 2, 4, and 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) scores.
The adjusted changes from baseline and their differences between treatment groups are presented.
The IBDQ is an instrument used to assess quality of life in adult patients with UC.
Subjects were asked to recall symptoms and QoL from last two weeks and to rate each item on a 7- point Likert score (higher scores equate to higher QoL).
Measured: From baseline to Week 2, 4, and 8
Number of Participants Experiencing Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a subject taking part in a clinical trial.
A 'treatment-emergent AE (TEAE)' is defined as an AE which occurs in the time interval from initial dosing (investigational medicinal product [IMP] intake) to the end of treatment visit.
Proportion of subjects with any TEAE (serious or non-serious) are presented.
Measured: Up to Week 16
Severity of Adverse Events
The proportion of subjects with intensity of AEs (classified as mild, moderate or severe) are presented.
Measured: Up to Week 16
Proportion of Subject With Abnormal Laboratory Values (Hematology)
Proportion of subjects with markedly abnormal changes from baseline in hematology values are presented.
>= greater than equal to; <= less than equal to.
Measured: Up to Week 16
Proportion of Subjects With Abnormal Laboratory Values (Coagulation)
Proportion of subjects with markedly abnormal changes from baseline values in coagulation laboratory values are presented.
INR= International normalized ratio.
Measured: Up to Week 16
Proportion of Subjects With Abnormal Laboratory Values (Serum Chemistry)
Proportion of subjects with markedly abnormal changes in serum chemistry laboratory values are presented.
ALT= Alanine aminotransferase; AST= Aspartate aminotransferase; BUN= Blood urea nitrogen; GGT= Gamma glutamyl transferase.
Measured: Up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startOct 2015
- Primary completion6 Feb 2018
- Study completion3 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522767
- Sponsor's protocol ID
- 000174
- Other IDs
- 2015-002557-35, 2015
- Status last verified
- Feb 2021
- First submitted
- 12 Aug 2015
- Last updated
- 15 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02522767
- Acronym / sponsor ID
- 000174
- Conditions
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2015 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Posted 15 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to investigate the efficacy of mesalamine for the induction of clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will receive 4 g extended release granules (sachet) once daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesalamine | Experimental | Drug: Mesalamine4 g extended release granules (sachet) |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female subjects aged 18 to 75 years
- Mild to moderate UC
Key exclusion criteria (11 listed)
- Disease limited to proctitis <15 cm
- Short bowel syndrome
- Prior colon resection surgery
- History of severe/fulminant UC
- Evidence of other forms of inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MesalamineAlso: Mesalazine, Pentasa | Drug | Mesalamine |
| Placebo | Drug | Placebo |
Primary outcome
Proportion of Subjects With Remission
Time frame: At Week 8
The proportion of subjects with remission was defined by the Clinical and Endoscopic Response Score: 0 for rectal bleeding; 0 or 1 with at least 1 point decrease from baseline for stool frequency; 0 or 1 for endoscopic score. The Clinical and Endoscopic Response Score ranged between 0-9, higher scores indicating greater disease severity. This score had two components: Clinical Response which assessed subject's symptoms and ranged between 0-6, and Endoscopic Response which assessed objective evidence of inflammation and ranged between 0-3. Further, the Clinical Response component included two subscales: stool frequency and rectal bleeding (each ranged between 0-3 each) obtained from subjects' daily records. The Endoscopic Response component had one subscale: flexible sigmoidoscopy/colonoscopy (ranging between 0-3).
14 secondary outcomes
Proportion of Subjects With Remission in the Primary Endpoint and the Physician's Global Assessment (PGA) Score of ≤1 (Modified Mayo Score)
Time frame: At Week 8
Time to Cessation of Rectal Bleeding
Time frame: Up to Week 8
The Proportion of Subjects With Endoscopic Improvement
Time frame: At Week 8
The Proportion of Subjects in Clinical Remission at Weeks 2, 4, and 8
Time frame: At Week 2, 4, and 8
Time to Normal Stool Pattern
Time frame: Up to Week 8
The Change From Baseline in Rectal Bleeding Score at Weeks 2, 4, and 8
Time frame: From baseline to Week 2, 4, and 8
The Change From Baseline in Serum C-reactive Protein (CRP) Levels at Weeks 2, 4, and 8
Time frame: From baseline to Week 2, 4, and 8
The Change From Baseline in Fecal Calprotectin Levels at Week 8
Time frame: From baseline to Week 8
The Change From Baseline in Health Related Quality of Life (QoL) Scores
Time frame: From baseline to Week 2, 4, and 8
Number of Participants Experiencing Adverse Events
Time frame: Up to Week 16
Severity of Adverse Events
Time frame: Up to Week 16
Proportion of Subject With Abnormal Laboratory Values (Hematology)
Time frame: Up to Week 16
Proportion of Subjects With Abnormal Laboratory Values (Coagulation)
Time frame: Up to Week 16
Proportion of Subjects With Abnormal Laboratory Values (Serum Chemistry)
Time frame: Up to Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
93 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mesalamine in people with Ulcerative Colitis, run by Ferring Pharmaceuticals at 93 sites in 11 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 2 inclusion and 11 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 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in Ukraine, United States, Russia, Poland, Bulgaria and 6 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. Some participants in this study may receive a placebo. 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 15 Mar 2021). 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?
Proportion of Subjects With Remission (time frame: At Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2021.