Ulcerative ColitisPhase 3NCT01059344
Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis
A Phase 3 study testing Mesalamin in people with Ulcerative Colitis, run by Tillotts Pharma AG at 31 sites in 4 countries.
Trial summary
The primary objective of the study is to determine the efficacy of Asacol™ 4.8 g/day (800 mg tablets) to induce clinical and endoscopic remission after 6 weeks of treatment compared to placebo in subjects with active ulcerative colitis (UC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Mesalamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 281 participants
- Where
- 31 sitesin 4 countries
- Study dates
- Nov 2009to Aug 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-lactating females, 18 years of age or older. (2) Documented diagnosis of UC with disease extending at least 15 cm from the anal verge.
- Active UC defined by:
- modified UC-DAI score of 4-10 with (b) sigmoidoscopy component score ≥ 2 and (c) rectal bleeding component score ≥ 1 (4) Ability of subject to participate fully in all aspects of this clinical trial.
- Written informed consent must be obtained and documented.
Who cannot join
- Severe UC defined by the following criteria:
- ³6 bloody stools daily with one or more of the following:
- oral temperature > 37.8°C or > 100.0°F
- pulse > 90/min
- hemoglobin < 10 g/dL
- Previously failed treatment with a mesalazine dose of > 2.0 g/day.
Show all 29Show fewer
- Current relapse lasting > 6 weeks in the opinion of the investigator.
- Treatment with 5-ASA at a dose of >2.0g/day within 1 week prior to randomisation
- Treatment with systemic or rectal steroids within 4 weeks prior to randomization.
- Treatment with immunosuppressants within 6 weeks prior to randomization.
- Treatment with infliximab or other biologics within 3 months prior to randomization.
- Treatment with systemic antibiotics for UC within 7 days prior to randomization.
- Treatment with probiotics within 7 days prior to randomization.
- Treatment with anti-diarrheals within 7 days prior to randomization.
- Treatment with nicotine patch within 7 days prior to randomization.
- Received any investigational drug within 30 days prior to randomization.
- History of colectomy or partial colectomy.
- History of definite dysplasia in colonic biopsies.
- Crohn's disease.
- Known bleeding disorders.
- Immediate or significant risk of toxic megacolon.
- Hypersensitivity to salicylates, aspirin, sulfasalazine or 5-ASA.
- Serum creatinine > 1.5 times the upper limit of the normal range.
- AST, ALT, total bilirubin or alkaline phosphatase > 2 times the upper limit of the normal range.
- Serious underlying disease other than UC which in the opinion of the investigator may interfere with the subject's ability to participate fully in the study.
- History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.
- Stools positive for clostridium difficile.
- Pregnant or lactating women.
- Prior enrolment in the current study and had received study treatment.
Trial locations and contacts
31 sites in 4 countries.
31 sites in 4 countries
Turkey (Türkiye)9 sites
Ankara University Medical Faculty Sihhiye
Ankara, 06100
Hacettepe University Medical Faculty Sihhiye
Ankara, 06100
Gazi University Medical Faculty Besevler
Ankara, 06500
Dicle University Medical Faculty
Diyarbakır, 21280
Trakya University Medical Faculty
Edirne, 22030
Gaziantep University Medical Faculty Kampus Alani
Gaziantep, 27310
Sisli Etfal Egitim ve Arastirma Hospital Sisli
Istanbul, 34360
Dokuz Eylul University Medical Faculty Inciralti
Izmir, 35340
Ataturk Egitim ve Arastirma Hospital Basin Sitesi
Izmir, 35360
India8 sites
M.S.Ramiah Hospital
Bangalore, Karnataka, 560 054
Life Line Hospital
Chennai, Tamil Nadu, 600 096
Medwin Hospital
Hyderabad, Andhrapradesh, 500 001
Osmania General Hospital
Hyderabad, Andhrapradesh, 500 012
S. R. Kalla Memorial Gastro and General Hospital
Jaipur, Rajasthan, 302 001
Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi, 110 002
Institute of liver and billiary sciences
New Delhi, 110 070
Shree Gokulam Medical College and Research Foundation
Trivandrum, Kerala, 695 607
Ukraine8 sites
Dnipropetrovska derzhavna medychna akademiia,
Dnipropetrovsk, 4904
Ivano-Frankivskyi natsionalnyi medychnyi universytet,
Ivano-Frankivsk
Miska klinichna likarnia 2,
Kharkiv, 61001
Natsionalnyi medychnyi universytet im. Bogomoltsia, kafedra khirurgii 1 na bazi viddilennia proctologii Miskoi klinichnoi likarni 18, m.Kyiv
Kyiv, 01030
Natsionalnyi medychnyi universytet im. O.O. Bogomoltsia,
Kyiv, 04053
Natsionalna medychna akademia pisliadyplomnoi osvity im. P.L. Shupyk,
Kyiv, 04201
Lvivskyi natsionalnyi medychnyi universytet imeni Danyla Galytskogo,
Lviv
Odeska oblasna klinichna likarnia, Oblasnyi tsentr gastroenterologii,
Odesa, 65039
Belarus6 sites
Gomel Regional Clinical Hospital, 9
Homyel, 23602
City Clinical Hospital No.1
Minsk, 220013
Minsk Regional Clinical Hospital, 41
Minsk, 2230
City Clinical Hospital No. 2
Minsk
E.Klumov City Clinical Hospital No. 3
Minsk
Vitebsk Regional Clinical Hospital
Vitebsk, 210037
About this study
Official title: A Randomized Placebo-Controlled Double-Blind Study to Evaluate the Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis
The primary objective of the study is to determine the efficacy of Asacol™ 4.8 g/day (800 mg tablets) to induce clinical and endoscopic remission after 6 weeks of treatment compared to placebo in subjects with active ulcerative colitis (UC).
Read the detailed description
The 800 mg Asacol™ tablets from Tillotts Pharma AG are being marketed in over 30 countries, mainly in Europe and Asia. Approved dosages for the treatment of active UC are between 2.4 and 4.8 g/day in analogy to the approved 400 mg dosage form. The present trial is planned to generate efficacy data to support the safe use of a 4.8 g/day dose of the 800 mg dosage form in a well defined population of patients with mildly to moderately active UC. In keeping with the EMEA UC guideline the study will have a placebo-controlled 6 weeks induction treatment. After 6 weeks, treatment success will be evaluated using the modified UC disease activity index as primary efficacy measurement.
- Conditions
- Ulcerative Colitis
- Being tested
- Mesalamin
- Keywords
- Mesalamine, Asacol, Ulcerative colitis, induction therapy, acute disease, mild to moderate, Active Ulcerative Colitis (mild to moderate)
- Medical subject headings
- Colitis, Ulcerative, Acute Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesalaminDrug
Also called Asacol
4.8g/day, 800 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Mesalamin | Experimental | 4.8g Mesalamin (800mg tablet) Receives: Drug: Mesalamin |
| Placebo | Placebo comparator | 4.8g Placebo to Mesalamin (800 mg tablet) Receives: Drug: Mesalamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC).
Clinical remission defined as stool frequency score of 0, rectal bleeding score of 0, no urgency
Measured: 6 weeks
Secondary outcomes (5)
Clinical Remission
Clinical remission defined as a score of 0 for stool frequency, 0 for rectal bleeding and no urgency
Measured: 10 weeks
Endoscopic Remission
Endoscopic remission is defined as a sigmoidoscopy score of 1 or less
Measured: 6 weeks
Endoscopic Remission
Endoscopic remission is defined as a sigmoidoscopy score of 1 or less
Measured: 10 weeks
Improvement
Improvement is defined as a reduction of at least 3 points from baseline in the modified UC-DAI score. (minumum 3, maximum 7, higher absolute UC-DAI scores indicate more severe disease)
Measured: 6 weeks
Improvement
Improvement is defined as a reduction of at least 3 points from baseline in the modified UC-DAI score. (minumum 3, maximum 7, higher absolute UC-DAI scores indicate more severe disease)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionJul 2011
- Study completionAug 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tillotts Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Feagan, MD, Study chair, Alimentiv Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059344
- Sponsor's protocol ID
- TP0203
- Status last verified
- Jun 2017
- First submitted
- 28 Jan 2010
- Last updated
- 2 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Feagan BG, Sandborn WJ, D'Haens G, Pola S, McDonald JWD, Rutgeerts P, Munkholm P, Mittmann U, King D, Wong CJ, Zou G, Donner A, Shackelton LM, Gilgen D, Nelson S, Vandervoort MK, Fahmy M, Loftus EV Jr, Panaccione R, Travis SP, Van Assche GA, Vermeire S, Levesque BG. The role of centralized reading of endoscopy in a randomized controlled trial of mesalamine for ulcerative colitis. Gastroenterology. 2013 Jul;145(1):149-157.e2. doi: 10.1053/j.gastro.2013.03.025. Epub 2013 Mar 22.
PubMed 23528626
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-Controlled Double-Blind Study to Evaluate the Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01059344
- Acronym / sponsor ID
- TP0203
- Conditions
- Ulcerative Colitis
- Keywords
- Mesalamine, Asacol, Ulcerative colitis, induction therapy, acute disease, mild to moderate, Active Ulcerative Colitis (mild to moderate)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Tillotts Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 29 Jan 2010 (estimated)
- Results
- Posted 24 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to determine the efficacy of Asacol™ 4.8 g/day (800 mg tablets) to induce clinical and endoscopic remission after 6 weeks of treatment compared to placebo in subjects with active ulcerative colitis (UC).
Detailed description
The 800 mg Asacol™ tablets from Tillotts Pharma AG are being marketed in over 30 countries, mainly in Europe and Asia. Approved dosages for the treatment of active UC are between 2.4 and 4.8 g/day in analogy to the approved 400 mg dosage form. The present trial is planned to generate efficacy data to support the safe use of a 4.8 g/day dose of the 800 mg dosage form in a well defined population of patients with mildly to moderately active UC. In keeping with the EMEA UC guideline the study will have a placebo-controlled 6 weeks induction treatment. After 6 weeks, treatment success will be evaluated using the modified UC disease activity index as primary efficacy measurement.
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 |
|---|---|---|
| Mesalamin | Experimental | Drug: Mesalamin4.8g Mesalamin (800mg tablet) |
| Placebo | Placebo comparator | Drug: Mesalamin4.8g Placebo to Mesalamin (800 mg tablet) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or non-pregnant, non-lactating females, 18 years of age or older. (2) Documented diagnosis of UC with disease extending at least 15 cm from the anal verge.
- Active UC defined by:
- modified UC-DAI score of 4-10 with (b) sigmoidoscopy component score ≥ 2 and (c) rectal bleeding component score ≥ 1 (4) Ability of subject to participate fully in all aspects of this clinical trial.
- Written informed consent must be obtained and documented.
Key exclusion criteria (29 listed)
- Severe UC defined by the following criteria:
- Previously failed treatment with a mesalazine dose of > 2.0 g/day.
- Current relapse lasting > 6 weeks in the opinion of the investigator.
- Treatment with 5-ASA at a dose of >2.0g/day within 1 week prior to randomisation
- Treatment with systemic or rectal steroids within 4 weeks prior to randomization.
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 |
|---|---|---|
| MesalaminAlso: Asacol4.8g/day, 800 mg tablets | Drug | Mesalamin, Placebo |
Primary outcome
To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC).
Time frame: 6 weeks
Clinical remission defined as stool frequency score of 0, rectal bleeding score of 0, no urgency
5 secondary outcomes
Clinical Remission
Time frame: 10 weeks
Endoscopic Remission
Time frame: 6 weeks
Endoscopic Remission
Time frame: 10 weeks
Improvement
Time frame: 6 weeks
Improvement
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23528626Feagan BG, Sandborn WJ, D'Haens G, Pola S, McDonald JWD, Rutgeerts P, Munkholm P, Mittmann U, King D, Wong CJ, Zou G, Donner A, Shackelton LM, Gilgen D, Nelson S, Vandervoort MK, Fahmy M, Loftus EV Jr, Panaccione R, Travis SP, Van Assche GA, Vermeire S, Levesque BG. The role of centralized reading of endoscopy in a randomized controlled trial of mesalamine for ulcerative colitis. Gastroenterology. 2013 Jul;145(1):149-157.e2. doi: 10.1053/j.gastro.2013.03.025. Epub 2013 Mar 22.
- Individual participant dataSharing planned: No
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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.
Brian Feagan, MD study chair
Alimentiv Inc.
31 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mesalamin in people with Ulcerative Colitis, run by Tillotts Pharma AG at 31 sites in 4 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 4 inclusion and 29 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 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Turkey (Türkiye), India, Ukraine, Belarus. 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 24 Apr 2017). 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?
To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC). (time frame: 6 weeks). 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 NCT01059344, 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 2 Aug 2017.