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

Purpose

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.

Condition	Intervention	Phase
Ulcerative Colitis	Drug: COLAL-PRED® Drug: Prednisolone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate

U.S. FDA Resources

Further study details as provided by Alizyme:

Primary Outcome Measures:

Disease activity index [ Time Frame: After 4 and 8 weeks of treatment ] [ Designated as safety issue: No ]
Cortisol levels [ Time Frame: After 4 and 8 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Simple clinical colitis activity index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Endoscopy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Laboratory tests [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	796
Study Start Date:	March 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: Prednisolone sodium metasulfobenzoate.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299013

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Locations

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

Sponsors and Collaborators

Alizyme

Investigators

Principal Investigator:

Christopher Hawkey

University Hospital, Nottingham

More Information

No publications provided

Responsible Party:	Research and Development Director, Alizyme
ClinicalTrials.gov Identifier:	NCT00299013 History of Changes
Other Study ID Numbers:	ATL2502/020/CL
Study First Received:	March 2, 2006
Last Updated:	April 24, 2008
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Alizyme:

Ulcerative colitis

Additional relevant MeSH terms:

Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate

Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013