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

Phase 3

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: Prednisolone; Drug: COLAL-PRED®

• Registration Number: NCT00299013
• Lead Sponsor: Alizyme

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-02
• Study First Submitted QC: 2006-03-02
• Study First Posted: 2006-03-06
• Status Verified: 2008-04
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Last Update Submitted: 2008-04-24
• Last Update Posted: 2008-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 796

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Prednisolone	Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
2	COLAL-PRED®	COLAL-PRED 40mg oral capsule, once daily for 8 weeks.
3	COLAL-PRED®	COLAL-PRED 60mg oral capsule, once daily for 8 weeks.
4	COLAL-PRED®	COLAL-PRED 80mg oral capsule, once daily for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Disease activity index	After 4 and 8 weeks of treatment
Cortisol levels	After 4 and 8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Simple clinical colitis activity index	8 weeks
Endoscopy	8 weeks
Adverse events	12 weeks
Laboratory tests	12 weeks

Trial Locations

Locations (54)

Fejer Megyei Szent Gyorgy Korhaz; 🇭🇺 Székesfehérvár, Hungary

Gastroenterologicka ambulance; 🇨🇿 Hradec Kralove, Czech Republic

Hepato-Gastroenterologie HK s.r.o.; 🇨🇿 Hradec Kralove, Czech Republic

Krajska nemocnice Liberec; 🇨🇿 Liberec, Czech Republic

Privatni odborna ambulance; 🇨🇿 Prague, Czech Republic

Oblastni nemocnice Pribram a.s.; 🇨🇿 Pribram, Czech Republic

Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza; 🇭🇺 Gyula, Hungary

Miskolc MJV Semmelweis Korhaz; 🇭🇺 Miskolc, Hungary

Okresni nemocnice Tabor; 🇨🇿 Tabor, Czech Republic

Vas Megyei Markusovszky Korhaz; 🇭🇺 Szombathely, Hungary

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, Klinika Gastroenterologii i Chorob Wewnetrznych; 🇵🇱 Bialystok, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Klinika Gastroenterologii; 🇵🇱 Lublin, Poland

Research Site; 🇬🇧 Sheffield, United Kingdom

Nemocnice v Usti nad Orlici; 🇨🇿 Usti nad Orlici, Czech Republic

Krajska nemocnice T Bati a s; 🇨🇿 Zlin, Czech Republic

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Hopital Saint Louis; 🇫🇷 Paris, France

Aalborg Hospital; 🇩🇰 Aalborg, Denmark

Gentofte Hospital; 🇩🇰 Hellerup, Denmark

Helsingors Hospital; 🇩🇰 Helsingor, Denmark

Hospital Haut Leveque; 🇫🇷 Pessac, France

CHU Nord Hepato-Gastroenterologie; 🇫🇷 Amiens, France

Hopital de l'Archet II; 🇫🇷 Nice, France

Petz Aladar Megyei Korhaz; 🇭🇺 Gyor, Hungary

Policlinico S. Orsola-Malpighi; 🇮🇹 Bologna, Italy

Am Wallgraben 99; 🇩🇪 Stuttgart, Germany

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

Wojskowy Szpital Kliniczny z Poliklinika Oddzial Gastroenterologii; 🇵🇱 Wroclaw, Poland

Kingsbury Hospital; 🇿🇦 Cape Town, South Africa

Fordsburg Clinic; 🇿🇦 Johannesburg, South Africa

Kloof Medi Clinic; 🇿🇦 Pretoria, South Africa

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; 🇵🇱 Warszawa, Poland

Karolinska University Hospital Solna; 🇸🇪 Stockholm, Sweden

Hospital Universitario Joan XXIII; 🇪🇸 Tarragona, Spain

Panorama Mediclinic; 🇿🇦 Cape Town, South Africa

Parklands Medical Centre; 🇿🇦 Durban, South Africa

Sophiahemmet Stockholm; 🇸🇪 Stockholm, Sweden

Norrlands University Hospital Umea; 🇸🇪 Umea, Sweden

Addenbrooke's Hospital; 🇬🇧 Cambridge, United Kingdom

Darent Valley Hospital; 🇬🇧 Dartford, United Kingdom

Western General Hospital; 🇬🇧 Edinburgh, United Kingdom

Hospital Clinic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario del Mar; 🇪🇸 Barcelona, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Royal Victoria Infirmary; 🇬🇧 Newcastle upon Tyne, United Kingdom

Hope Hospital; 🇬🇧 Salford, United Kingdom

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

Leicester General Hospital; 🇬🇧 Leicester, United Kingdom

Hammersmith Hospital; 🇬🇧 London, United Kingdom

Middlesex Hospital; 🇬🇧 London, United Kingdom

University Hospital; 🇬🇧 Nottingham, United Kingdom