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

Sponsor:	Alizyme
Information provided by:	Alizyme
ClinicalTrials.gov Identifier:	NCT00299013

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy 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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate 16-Methyleneprednisolone Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

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
1: Active Comparator 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.
2: Experimental 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.
3: Experimental 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.
4: Experimental 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.

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

Sponsors and Collaborators

Alizyme

Investigators

Principal Investigator:

Christopher Hawkey

University Hospital, Nottingham

More Information

No publications provided

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

Keywords provided by Alizyme:

Ulcerative colitis

Additional relevant MeSH terms:

Ulcer
Colitis
Colitis, Ulcerative
Anti-Inflammatory Agents
Gastrointestinal Diseases
Methylprednisolone
Antineoplastic Agents
Colonic Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Inflammatory Bowel Diseases
Antiemetics
Prednisolone acetate
Neuroprotective Agents
Hormones

Pathologic Processes
Therapeutic Uses
Methylprednisolone Hemisuccinate
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Methylprednisolone acetate
Intestinal Diseases
Protective Agents
Glucocorticoids
Pharmacologic Actions
Digestive System Diseases
Autonomic Agents
Prednisolone
Peripheral Nervous System Agents
Gastroenteritis

ClinicalTrials.gov processed this record on November 30, 2009