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

April 24, 2008 updated by: Alizyme

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

796

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Bankstown, New South Wales, Australia, 2200
        • Research Site
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Research Site
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Research Site
  • Belgium
      • Bruxelles, Belgium, 1070
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Roeselare, Belgium, 8800
        • Research Site
  • Czech Republic
      • Hradec Kralove, Czech Republic
        • Gastroenterologicka ambulance
      • Hradec Kralove, Czech Republic
        • Hepato-Gastroenterologie HK s.r.o.
      • Liberec, Czech Republic
        • Krajska Nemocnice Liberec
      • Olomouc, Czech Republic, 77520
        • Research Site
      • Prague, Czech Republic
        • Privatni odborna ambulance
      • Praha 10, Czech Republic, 100 34
        • Research Site
      • Pribram, Czech Republic
        • Oblastni nemocnice Pribram a.s.
      • Tabor, Czech Republic
        • Okresni nemocnice Tabor
      • Usti nad Orlici, Czech Republic
        • Nemocnice v Usti nad Orlici
      • Zlin, Czech Republic, 762 75
        • Research Site
      • Zlin, Czech Republic
        • Krajska nemocnice T Bati a s
  • Denmark
      • Aalborg, Denmark
        • Aalborg Hospital
      • Hellerup, Denmark
        • Gentofte Hospital
      • Helsingor, Denmark
        • Helsingors Hospital
      • Hvidovre, Denmark
        • Hvidovre Hospital
  • France
      • Amiens, France
        • CHU Nord Hepato-Gastroenterologie
      • Nice, France
        • Hôpital de l'Archet II
      • Paris, France
        • Hopital Saint Louis
      • Pessac, France
        • Hospital Haut levêque
  • Germany
      • Stuttgart, Germany
        • Am Wallgraben 99
  • Hungary
      • Debrecen, Hungary, H-4012
        • Research Site
      • Dunaujvaros, Hungary, H-2400
        • Research Site
      • Eger, Hungary, H-3300
        • Research Site
      • Gyor, Hungary
        • Petz Aladar Megyei Korhaz
      • Gyula, Hungary
        • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
      • Hatvan, Hungary, H-3000
        • Research Site
      • Miskolc, Hungary
        • Miskolc MJV Semmelweis Korhaz
      • Szekszard, Hungary, H-7100
        • Research Site
      • Szombathely, Hungary
        • Vas Megyei Markusovszky Korhaz
      • Székesfehérvár, Hungary
        • Fejer Megyei Szent Gyorgy Korhaz
      • Vac, Hungary, H-2601
        • Research Site
  • Israel
      • Haifa, Israel, 31096
        • Research Site
      • Jerusalem, Israel, 91031
        • Research Site
      • Kfar Saba, Israel, 44281
        • Research Site
      • Petah-Tikva, Israel
        • Research Site
      • Rehovot, Israel, 76100
        • Research Site
      • Tel-Aviv, Israel
        • Research Site
  • Italy
      • Bologna, Italy
        • Policlinico S. Orsola-Malpighi
  • Poland
      • Bialystok, Poland
        • Samodzielny Publiczny Szpital Kliniczny, Klinika Gastroenterologii i Chorob Wewnetrznych
      • Lodz, Poland
        • SP ZOZ Uniwersytecki Szpital Kliniczny Nr 5 im. gen. dyw. Boleslawa Szareckiego Uniwersytetu Medycznego w Lodzi Oddział Gastroenterologii i Chorob Wewnetrznych
      • Lublin, Poland
        • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Klinika Gastroenterologii
      • Pruszkow, Poland
        • Szpital Kolejowy w Pruszkowie Oddzial Wewnetrzny
      • Szczecin, Poland
        • SPSK Nr 1 im. Prof. Tadeusza Sokolowskiego Pomorskiej Akademii Medycznej Klinika Gastroenterologii i Chorob Wewnetrznych
      • Torun, Poland, 87-100
        • Research Site
      • Warszawa, Poland, 03-563
        • Research Site
      • Warszawa, Poland
        • Centrum Onkologii-Instytutu im. Marii Skłodowskiej-Curie Klinika Gastroenterologii
      • Warszawa, Poland
        • Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Katedra i Klinika Gastroenterologii i Chorób Przemiany Materii
      • Wroclaw, Poland
        • Wojskowy Szpital Kliniczny z Poliklinika Oddzial Gastroenterologii
  • Russian Federation
      • Moscow, Russian Federation, 105203
        • Research Site
      • St. Petersburg, Russian Federation, 195067
        • Research Site
  • South Africa
      • Cape Town, South Africa
        • Kingsbury Hospital
      • Cape Town, South Africa
        • Panorama MediClinic
      • Durban, South Africa
        • Parklands Medical Centre
      • Johannesburg, South Africa
        • Fordsburg Clinic
      • Pretoria, South Africa
        • Kloof Medi Clinic
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6057
        • Research Site
    • Western Cape
      • Cape Town, Western Cape, South Africa
        • Research Site
  • Spain
      • Barcelona, Spain
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain
        • Hospital Universitario del Mar
      • Madrid, Spain, 28034
        • Research Site
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Tarragona, Spain
        • Hospital Universitario Joan XXIII
    • Andalucia
      • Cordoba, Andalucia, Spain, 14004
        • Research Site
  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital Solna
      • Stockholm, Sweden
        • Sophiahemmet Stockholm
      • Umea, Sweden
        • Norrlands University Hospital Umea
  • United Kingdom
      • Cambridge, United Kingdom
        • Addenbrooke's Hospital
      • Cottingham, United Kingdom, HU16 5JQ
        • Research Site
      • Dartford, United Kingdom
        • Darent Valley Hospital
      • Edinburgh, United Kingdom
        • Western General Hospital
      • Edinburgh, United Kingdom, EH16 4SA
        • Research Site
      • Leeds, United Kingdom
        • Leeds General Infirmary
      • Leicester, United Kingdom
        • Leicester General Hospital
      • Liverpool, United Kingdom, L7 8XP
        • Research Site
      • London, United Kingdom
        • Hammersmith Hospital
      • London, United Kingdom
        • Middlesex Hospital
      • Newcastle upon Tyne, United Kingdom
        • Royal Victoria Infirmary
      • Nottingham, United Kingdom
        • University Hospital
      • Salford, United Kingdom
        • Hope Hospital
      • Sheffield, United Kingdom, S10 2JF
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
Drug: Prednisolone
Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
Experimental: 2
COLAL-PRED 40mg oral capsule, once daily for 8 weeks.
Drug: COLAL-PRED®
COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
Other Names:
  • Prednisolone sodium metasulfobenzoate.
Experimental: 3
COLAL-PRED 60mg oral capsule, once daily for 8 weeks.
Drug: COLAL-PRED®
COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
Other Names:
  • Prednisolone sodium metasulfobenzoate.
Experimental: 4
COLAL-PRED 80mg oral capsule, once daily for 8 weeks.
Drug: COLAL-PRED®
COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
Other Names:
  • Prednisolone sodium metasulfobenzoate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease activity index
Time Frame: After 4 and 8 weeks of treatment
After 4 and 8 weeks of treatment
Cortisol levels
Time Frame: After 4 and 8 weeks of treatment
After 4 and 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 12 weeks
12 weeks
Simple clinical colitis activity index
Time Frame: 8 weeks
8 weeks
Endoscopy
Time Frame: 8 weeks
8 weeks
Laboratory tests
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alizyme

Investigators

  • Principal Investigator: Christopher Hawkey, University Hospital, Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

March 2, 2006

First Submitted That Met QC Criteria

March 2, 2006

First Posted (Estimate)

March 6, 2006

Study Record Updates

Last Update Posted (Estimate)

April 25, 2008

Last Update Submitted That Met QC Criteria

April 24, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATL2502/020/CL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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