search
Back to results

Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
COLAL-PRED®
Prednisolone
Sponsored by
Alizyme
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Endoscopically confirmed diagnosis of ulcerative colitis Score of 6-10 on the Disease Activity Index (DAI) Moderate to severe mucosal appearance Exclusion Criteria: 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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Gastroenterologicka ambulance
  • Hepato-Gastroenterologie HK s.r.o.
  • Krajska nemocnice Liberec
  • Research Site
  • Privatni odborna ambulance
  • Research Site
  • Oblastni nemocnice Pribram a.s.
  • Okresni nemocnice Tabor
  • Nemocnice v Usti nad Orlici
  • Research Site
  • Krajska nemocnice T Bati a s
  • Aalborg Hospital
  • Gentofte Hospital
  • Helsingors Hospital
  • Hvidovre Hospital
  • CHU Nord Hepato-Gastroenterologie
  • Hopital de l'Archet II
  • Hopital Saint Louis
  • Hospital Haut Leveque
  • Am Wallgraben 99
  • Research Site
  • Research Site
  • Research Site
  • Petz Aladar Megyei Korhaz
  • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
  • Research Site
  • Miskolc MJV Semmelweis Korhaz
  • Research Site
  • Vas Megyei Markusovszky Korhaz
  • Fejer Megyei Szent Gyorgy Korhaz
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Policlinico S. Orsola-Malpighi
  • Samodzielny Publiczny Szpital Kliniczny, Klinika Gastroenterologii i Chorob Wewnetrznych
  • SP ZOZ Uniwersytecki Szpital Kliniczny Nr 5 im. gen. dyw. Boleslawa Szareckiego Uniwersytetu Medycznego w Lodzi Oddział Gastroenterologii i Chorob Wewnetrznych
  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Klinika Gastroenterologii
  • Szpital Kolejowy w Pruszkowie Oddzial Wewnetrzny
  • SPSK Nr 1 im. Prof. Tadeusza Sokolowskiego Pomorskiej Akademii Medycznej Klinika Gastroenterologii i Chorob Wewnetrznych
  • Research Site
  • Research Site
  • Centrum Onkologii-Instytutu im. Marii Skłodowskiej-Curie Klinika Gastroenterologii
  • Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Katedra i Klinika Gastroenterologii i Chorób Przemiany Materii
  • Wojskowy Szpital Kliniczny z Poliklinika Oddzial Gastroenterologii
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Kingsbury Hospital
  • Panorama Mediclinic
  • Parklands Medical Centre
  • Fordsburg Clinic
  • Kloof Medi Clinic
  • Research Site
  • Hospital Clinic i Provincial de Barcelona
  • Hospital Universitario del Mar
  • Research Site
  • Hospital Clínico San Carlos
  • Hospital Universitario Joan XXIII
  • Karolinska University Hospital Solna
  • Sophiahemmet Stockholm
  • Norrlands University Hospital Umea
  • Addenbrooke's Hospital
  • Research Site
  • Darent Valley Hospital
  • Research Site
  • Western General Hospital
  • Leeds General Infirmary
  • Leicester General Hospital
  • Research Site
  • Hammersmith Hospital
  • Middlesex Hospital
  • Royal Victoria Infirmary
  • University Hospital
  • Hope Hospital
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.

COLAL-PRED 40mg oral capsule, once daily for 8 weeks.

COLAL-PRED 60mg oral capsule, once daily for 8 weeks.

COLAL-PRED 80mg oral capsule, once daily for 8 weeks.

Outcomes

Primary Outcome Measures

Disease activity index
Cortisol levels

Secondary Outcome Measures

Simple clinical colitis activity index
Endoscopy
Adverse events
Laboratory tests

Full Information

First Posted
March 2, 2006
Last Updated
April 24, 2008
Sponsor
Alizyme
search

1. Study Identification

Unique Protocol Identification Number
NCT00299013
Brief Title
Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Alizyme

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
796 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
Arm Title
2
Arm Type
Experimental
Arm Description
COLAL-PRED 40mg oral capsule, once daily for 8 weeks.
Arm Title
3
Arm Type
Experimental
Arm Description
COLAL-PRED 60mg oral capsule, once daily for 8 weeks.
Arm Title
4
Arm Type
Experimental
Arm Description
COLAL-PRED 80mg oral capsule, once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
COLAL-PRED®
Other Intervention Name(s)
Prednisolone sodium metasulfobenzoate.
Intervention Description
COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
Primary Outcome Measure Information:
Title
Disease activity index
Time Frame
After 4 and 8 weeks of treatment
Title
Cortisol levels
Time Frame
After 4 and 8 weeks of treatment
Secondary Outcome Measure Information:
Title
Simple clinical colitis activity index
Time Frame
8 weeks
Title
Endoscopy
Time Frame
8 weeks
Title
Adverse events
Time Frame
12 weeks
Title
Laboratory tests
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Endoscopically confirmed diagnosis of ulcerative colitis Score of 6-10 on the Disease Activity Index (DAI) Moderate to severe mucosal appearance Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Hawkey
Organizational Affiliation
University Hospital, Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Bankstown
State/Province
New South Wales
ZIP/Postal Code
2200
Country
Australia
Facility Name
Research Site
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Research Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Gastroenterologicka ambulance
City
Hradec Kralove
Country
Czech Republic
Facility Name
Hepato-Gastroenterologie HK s.r.o.
City
Hradec Kralove
Country
Czech Republic
Facility Name
Krajska nemocnice Liberec
City
Liberec
Country
Czech Republic
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
Facility Name
Privatni odborna ambulance
City
Prague
Country
Czech Republic
Facility Name
Research Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czech Republic
Facility Name
Oblastni nemocnice Pribram a.s.
City
Pribram
Country
Czech Republic
Facility Name
Okresni nemocnice Tabor
City
Tabor
Country
Czech Republic
Facility Name
Nemocnice v Usti nad Orlici
City
Usti nad Orlici
Country
Czech Republic
Facility Name
Research Site
City
Zlin
ZIP/Postal Code
762 75
Country
Czech Republic
Facility Name
Krajska nemocnice T Bati a s
City
Zlin
Country
Czech Republic
Facility Name
Aalborg Hospital
City
Aalborg
Country
Denmark
Facility Name
Gentofte Hospital
City
Hellerup
Country
Denmark
Facility Name
Helsingors Hospital
City
Helsingor
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
Country
Denmark
Facility Name
CHU Nord Hepato-Gastroenterologie
City
Amiens
Country
France
Facility Name
Hopital de l'Archet II
City
Nice
Country
France
Facility Name
Hopital Saint Louis
City
Paris
Country
France
Facility Name
Hospital Haut Leveque
City
Pessac
Country
France
Facility Name
Am Wallgraben 99
City
Stuttgart
Country
Germany
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
H-4012
Country
Hungary
Facility Name
Research Site
City
Dunaujvaros
ZIP/Postal Code
H-2400
Country
Hungary
Facility Name
Research Site
City
Eger
ZIP/Postal Code
H-3300
Country
Hungary
Facility Name
Petz Aladar Megyei Korhaz
City
Gyor
Country
Hungary
Facility Name
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
City
Gyula
Country
Hungary
Facility Name
Research Site
City
Hatvan
ZIP/Postal Code
H-3000
Country
Hungary
Facility Name
Miskolc MJV Semmelweis Korhaz
City
Miskolc
Country
Hungary
Facility Name
Research Site
City
Szekszard
ZIP/Postal Code
H-7100
Country
Hungary
Facility Name
Vas Megyei Markusovszky Korhaz
City
Szombathely
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Korhaz
City
Székesfehérvár
Country
Hungary
Facility Name
Research Site
City
Vac
ZIP/Postal Code
H-2601
Country
Hungary
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Research Site
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Research Site
City
Petah-Tikva
Country
Israel
Facility Name
Research Site
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Research Site
City
Tel-Aviv
Country
Israel
Facility Name
Policlinico S. Orsola-Malpighi
City
Bologna
Country
Italy
Facility Name
Samodzielny Publiczny Szpital Kliniczny, Klinika Gastroenterologii i Chorob Wewnetrznych
City
Bialystok
Country
Poland
Facility Name
SP ZOZ Uniwersytecki Szpital Kliniczny Nr 5 im. gen. dyw. Boleslawa Szareckiego Uniwersytetu Medycznego w Lodzi Oddział Gastroenterologii i Chorob Wewnetrznych
City
Lodz
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Klinika Gastroenterologii
City
Lublin
Country
Poland
Facility Name
Szpital Kolejowy w Pruszkowie Oddzial Wewnetrzny
City
Pruszkow
Country
Poland
Facility Name
SPSK Nr 1 im. Prof. Tadeusza Sokolowskiego Pomorskiej Akademii Medycznej Klinika Gastroenterologii i Chorob Wewnetrznych
City
Szczecin
Country
Poland
Facility Name
Research Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
03-563
Country
Poland
Facility Name
Centrum Onkologii-Instytutu im. Marii Skłodowskiej-Curie Klinika Gastroenterologii
City
Warszawa
Country
Poland
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Katedra i Klinika Gastroenterologii i Chorób Przemiany Materii
City
Warszawa
Country
Poland
Facility Name
Wojskowy Szpital Kliniczny z Poliklinika Oddzial Gastroenterologii
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
105203
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Research Site
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6057
Country
South Africa
Facility Name
Research Site
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Kingsbury Hospital
City
Cape Town
Country
South Africa
Facility Name
Panorama Mediclinic
City
Cape Town
Country
South Africa
Facility Name
Parklands Medical Centre
City
Durban
Country
South Africa
Facility Name
Fordsburg Clinic
City
Johannesburg
Country
South Africa
Facility Name
Kloof Medi Clinic
City
Pretoria
Country
South Africa
Facility Name
Research Site
City
Cordoba
State/Province
Andalucia
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario del Mar
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Joan XXIII
City
Tarragona
Country
Spain
Facility Name
Karolinska University Hospital Solna
City
Stockholm
Country
Sweden
Facility Name
Sophiahemmet Stockholm
City
Stockholm
Country
Sweden
Facility Name
Norrlands University Hospital Umea
City
Umea
Country
Sweden
Facility Name
Addenbrooke's Hospital
City
Cambridge
Country
United Kingdom
Facility Name
Research Site
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Darent Valley Hospital
City
Dartford
Country
United Kingdom
Facility Name
Research Site
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
Country
United Kingdom
Facility Name
Leicester General Hospital
City
Leicester
Country
United Kingdom
Facility Name
Research Site
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
Country
United Kingdom
Facility Name
Middlesex Hospital
City
London
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
Country
United Kingdom
Facility Name
University Hospital
City
Nottingham
Country
United Kingdom
Facility Name
Hope Hospital
City
Salford
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis

We'll reach out to this number within 24 hrs