Ulcerative ColitisPhase 3NCT00299013
Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis
A Phase 3 study testing COLAL-PRED® and Prednisolone in people with Ulcerative Colitis, run by Alizyme at 86 sites in 15 countries.
Trial summary
The purpose of this study is to investigate whether a novel dosage form of a prednisolone ester, called COLAL-PRED®, is useful in the treatment of ulcerative colitis. 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?
- COLAL-PRED® and Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 796 participants
- Where
- 86 sitesin 15 countries
- Study dates
- Mar 2006to Apr 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Endoscopically confirmed diagnosis of ulcerative colitis
- Score of 6-10 on the Disease Activity Index (DAI)
- Moderate to severe mucosal appearance
Who cannot join
- Previous colonic surgery
- Other treatments for ulcerative colitis that have not been stabilised
- Clinically significant diabetes, heart failure, unstable angina, cirrhosis, renal failure
- History of tuberculosis
Trial locations and contacts
86 sites in 15 countries.
86 sites in 15 countries
United Kingdom14 sites
Addenbrooke's Hospital
Cambridge
Research Site
Cottingham, HU16 5JQ
Darent Valley Hospital
Dartford
Research Site
Edinburgh, EH16 4SA
Western General Hospital
Edinburgh
Leeds General Infirmary
Leeds
Leicester General Hospital
Leicester
Research Site
Liverpool, L7 8XP
Hammersmith Hospital
London
Middlesex Hospital
London
Royal Victoria Infirmary
Newcastle upon Tyne
University Hospital
Nottingham
Hope Hospital
Salford
Research Site
Sheffield, S10 2JF
Czechia11 sites
Gastroenterologicka ambulance
Hradec Králové
Hepato-Gastroenterologie HK s.r.o.
Hradec Králové
Krajska nemocnice Liberec
Liberec
Research Site
Olomouc, 77520
Research Site
Prague, 100 34
Privatni odborna ambulance
Prague
Oblastni nemocnice Pribram a.s.
Příbram
Okresni nemocnice Tabor
Tábor
Nemocnice v Usti nad Orlici
Ústí nad Orlicí
Research Site
Zlín, 762 75
Krajska nemocnice T Bati a s
Zlín
Hungary11 sites
Research Site
Debrecen, H-4012
Research Site
Dunaújváros, H-2400
Research Site
Eger, H-3300
Petz Aladar Megyei Korhaz
Győr
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
Gyula
Research Site
Hatvan, H-3000
Miskolc MJV Semmelweis Korhaz
Miskolc
Fejer Megyei Szent Gyorgy Korhaz
Székesfehérvár
Research Site
Szekszárd, H-7100
Vas Megyei Markusovszky Korhaz
Szombathely
Research Site
Vác, H-2601
Poland10 sites
Samodzielny Publiczny Szpital Kliniczny, Klinika Gastroenterologii i Chorob Wewnetrznych
Bialystok
SP ZOZ Uniwersytecki Szpital Kliniczny Nr 5 im. gen. dyw. Boleslawa Szareckiego Uniwersytetu Medycznego w Lodzi Oddział Gastroenterologii i Chorob Wewnetrznych
Lodz
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Klinika Gastroenterologii
Lublin
Szpital Kolejowy w Pruszkowie Oddzial Wewnetrzny
Pruszków
SPSK Nr 1 im. Prof. Tadeusza Sokolowskiego Pomorskiej Akademii Medycznej Klinika Gastroenterologii i Chorob Wewnetrznych
Szczecin
Research Site
Torun, 87-100
Research Site
Warsaw, 03-563
Centrum Onkologii-Instytutu im. Marii Skłodowskiej-Curie Klinika Gastroenterologii
Warsaw
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Katedra i Klinika Gastroenterologii i Chorób Przemiany Materii
Warsaw
Wojskowy Szpital Kliniczny z Poliklinika Oddzial Gastroenterologii
Wroclaw
South Africa7 sites
Research Site
Cape Town, Western Cape
Kingsbury Hospital
Cape Town
Panorama Mediclinic
Cape Town
Parklands Medical Centre
Durban
Fordsburg Clinic
Johannesburg
Research Site
Port Elizabeth, Eastern Cape, 6057
Kloof Medi Clinic
Pretoria
Israel6 sites
Research Site
Haifa, 31096
Research Site
Jerusalem, 91031
Research Site
Kfar Saba, 44281
Research Site
Petah Tikva
Research Site
Rehovot, 76100
Research Site
Tel Aviv
Spain6 sites
Hospital Clinic i Provincial de Barcelona
Barcelona
Hospital Universitario del Mar
Barcelona
Research Site
Córdoba, Andalusia, 14004
Research Site
Madrid, 28034
Hospital Clínico San Carlos
Madrid
Hospital Universitario Joan XXIII
Tarragona
Denmark4 sites
Aalborg Hospital
Aalborg
Helsingors Hospital
Elsinore
Gentofte Hospital
Hellerup
Hvidovre Hospital
Hvidovre
France4 sites
CHU Nord Hepato-Gastroenterologie
Amiens
Hopital de l'Archet II
Nice
Hopital Saint Louis
Paris
Hospital Haut Leveque
Pessac
Australia3 sites
Research Site
Bankstown, New South Wales, 2200
Research Site
Bedford Park, South Australia, 5042
Research Site
Parkville, Victoria, 3050
Belgium3 sites
Research Site
Brussels, 1070
Research Site
Ghent, 9000
Research Site
Roeselare, 8800
Sweden3 sites
Karolinska University Hospital Solna
Stockholm
Sophiahemmet Stockholm
Stockholm
Norrlands University Hospital Umea
Umeå
Russia2 sites
Research Site
Moscow, 105203
Research Site
Saint Petersburg, 195067
About this study
Official title: A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis
The purpose of this study is to investigate whether a novel dosage form of a prednisolone ester, called COLAL-PRED®, is useful in the treatment of ulcerative colitis.
Read the detailed description
Ulcerative colitis is a disease that causes inflammation of the large bowel, causing fever, diarrhoea, dehydration and other symptoms. Standard treatment for ulcerative colitis includes general medical treatments such as fluid and salt replacement and attention to diet. Anti-inflammatory medicines such as steroids (e.g. prednisolone) and aminosalicylates (e.g. mesalazine) are the main drug treatments.
This study will investigate whether COLAL-PRED®, a novel dosage form of a prednisolone ester, is safe and effective in the treatment of ulcerative colitis, compared with the standard treatment (conventional prednisolone) and also to determine which dose which will work best for future patients.
- Conditions
- Ulcerative Colitis
- Being tested
- COLAL-PRED®, Prednisolone
- Keywords
- Ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COLAL-PRED®Drug
Also called Prednisolone sodium metasulfobenzoate.
COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
PrednisoloneDrug
Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks. Receives: Drug: Prednisolone |
| 2 | Experimental | COLAL-PRED 40mg oral capsule, once daily for 8 weeks. Receives: Drug: COLAL-PRED® |
| 3 | Experimental | COLAL-PRED 60mg oral capsule, once daily for 8 weeks. Receives: Drug: COLAL-PRED® |
| 4 | Experimental | COLAL-PRED 80mg oral capsule, once daily for 8 weeks. Receives: Drug: COLAL-PRED® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity index
Measured: After 4 and 8 weeks of treatment
Cortisol levels
Measured: After 4 and 8 weeks of treatment
Secondary outcomes (4)
Simple clinical colitis activity index
Measured: 8 weeks
Endoscopy
Measured: 8 weeks
Adverse events
Measured: 12 weeks
Laboratory tests
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 796 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alizyme
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christopher Hawkey, Principal investigator, University Hospital, Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299013
- Sponsor's protocol ID
- ATL2502/020/CL
- Status last verified
- Apr 2008
- First submitted
- 2 Mar 2006
- Last updated
- 25 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00299013
- Acronym / sponsor ID
- ATL2502/020/CL
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 796 participants (actual)
- Lead sponsor
- AlizymeIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 6 Mar 2006 (estimated)
- Results
- Not posted in the source record
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 study is to investigate whether a novel dosage form of a prednisolone ester, called COLAL-PRED®, is useful in the treatment of ulcerative colitis.
Detailed description
Ulcerative colitis is a disease that causes inflammation of the large bowel, causing fever, diarrhoea, dehydration and other symptoms. Standard treatment for ulcerative colitis includes general medical treatments such as fluid and salt replacement and attention to diet. Anti-inflammatory medicines such as steroids (e.g. prednisolone) and aminosalicylates (e.g. mesalazine) are the main drug treatments.
This study will investigate whether COLAL-PRED®, a novel dosage form of a prednisolone ester, is safe and effective in the treatment of ulcerative colitis, compared with the standard treatment (conventional prednisolone) and also to determine which dose which will work best for future patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: PrednisolonePrednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks. |
| 2 | Experimental | Drug: COLAL-PRED®COLAL-PRED 40mg oral capsule, once daily for 8 weeks. |
| 3 | Experimental | Drug: COLAL-PRED®COLAL-PRED 60mg oral capsule, once daily for 8 weeks. |
| 4 | Experimental | Drug: COLAL-PRED®COLAL-PRED 80mg oral capsule, once daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Endoscopically confirmed diagnosis of ulcerative colitis
- Score of 6-10 on the Disease Activity Index (DAI)
- Moderate to severe mucosal appearance
Key exclusion criteria (4 listed)
- Previous colonic surgery
- Other treatments for ulcerative colitis that have not been stabilised
- Clinically significant diabetes, heart failure, unstable angina, cirrhosis, renal failure
- History of tuberculosis
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 |
|---|---|---|
| COLAL-PRED®Also: Prednisolone sodium metasulfobenzoate.COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks. | Drug | 2, 3, 4 |
| PrednisolonePrednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks. | Drug | 1 |
Primary outcome
Disease activity index
Time frame: After 4 and 8 weeks of treatment
Cortisol levels
Time frame: After 4 and 8 weeks of treatment
4 secondary outcomes
Simple clinical colitis activity index
Time frame: 8 weeks
Endoscopy
Time frame: 8 weeks
Adverse events
Time frame: 12 weeks
Laboratory tests
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2008.
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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.
Christopher Hawkey principal investigator
University Hospital, Nottingham
86 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing COLAL-PRED® and Prednisolone in people with Ulcerative Colitis, run by Alizyme at 86 sites in 15 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 3 inclusion and 4 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 25 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United Kingdom, Czechia, Hungary, Poland, South Africa and 10 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease activity index (time frame: After 4 and 8 weeks of treatment). 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?
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 25 Apr 2008.