Dose Finding Study in Colorectal Cancer Patients Receiving 5-FU-based Chemotherapy to Assess the Efficacy of Elsiglutide in the Prevention of Chemotherapy Induced Diarrhea (CID)

PHASE2CompletedINTERVENTIONAL
Enrollment

498

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

February 29, 2016

Study Completion Date

February 29, 2016

Conditions
Drug and/or Toxin-induced Diarrhea
Interventions
DRUG

Elsiglutide

DRUG

Placebo

Trial Locations (54)

1083

Semmelweis Egyetem, ÁOK I. Sz. Belgyógyászati Klinika, Onkológiai Részleg, Budapest

1122

"Országos Onkológiai Intézet C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály", Budapest

1145

Uzsoki Utcai Kórház Onkoradiológia, Sugárterápia, ővárosi Onkoradiológiai Központ, Budapest

1330

Multifunctional Hospital for Active Treatment for Women's Health Nadezhda Ltd., Sofia

4000

"''Multifunctional Hospital for Active Treatment Central Onco Hospital Ltd", Plovdiv

Complex Oncology Centre - Plovdiv Ltd, Plovdiv

4032

Debreceni Egyetem, OEC Onkológiai Tanszék, Debrecen

4400

Jósa András Oktatókórház Onkoradiológiai Osztály, Nyíregyháza

5000

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház Onkológiai Osztály, Szolnok

6300

Specialized Hospital for active treatment in oncology - Haskovo Ltd, Haskovo

6720

Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ Onkoterápiás Klinika, Szeged

7400

Somogy Megyei Kaposi Mór Oktató Kórház Klinikai Onkológiai Osztály, Kaposvár

14029

"Chernigiv medical and prophylactic establishment Chernigiv regional oncological center", Chernihiv

25011

"Municipal institution Kirovograd Regional Oncology Center", Kropyvnytskyi

49102

Communal Institution Dnipropetrovsk City Multifunctional Clinical Hospital #4, Dnipropetrovsk

50000

Regional Сommunal Institution Kryvyi Rig Oncology Dispensary, Kryvyi Rih

53203

Pardubicka krajska nemocnice a.s, Pardubice

61070

Communal Institution Kharkiv Regional Clinical Oncology Center, Kharkiv

76000

Ivano-Frankivsk Regional Oncological Center, Ivano-Frankivsk

79031

Lviv State Oncological Regional Treatment and Preventive Center, Lviv

81737

Klinikum Neuperlach, München

115478

"Federal State Budgetary Institution Russian Oncology Scientific Centre named after N.N. Blokhin of the Russian Academy of Medical Science", Moscow

163045

"State Budgetary Institution of Arkhangelsk Region Arkhangelsk Clinical Oncology Dispensary", Arkhangelsk

197022

"State Budgetary Educational Institution of Higher Professional Education First Saint Petersburg State Medical University named after Academician I.P. Pavlov", Saint Petersburg

197110

"State Healthcare Institution City Hospital #9 (Saint Petersburg Theoretical & Practical Centre of Coloproctology)", Saint Petersburg

212018

Healthcare Institution Mogilev Regional Oncologic Dispensary, Mogilev

220013

Healthcare Institution Minsk City Clinical Oncologic Dispensary, Minsk

223040

"State Institution Republic Scientific and Practical Center of oncology and medical radiology n.a.N.N.Alexandrov", Lyasny

224027

Healthcare Institution Brest Regional Oncologic Dispensary, Brest

246012

Institution Gomel Regional Clinical Oncology Dispensary, Homyel

302020

"Budgetary Healthcare Institution of Orel Region Orel Oncology Dispensary", Oryol

305035

"State Healthcare Institution Kursk Regional Clinical Oncology Dispensary", Kursk

357502

"State Budgetary Healthcare Institution of Stavropol Territory Pyatigorsk Oncology Dispensary", Pyatigorsk

404130

"State Budgetary Healthcare Institution Volgograd Regional Oncology Dispensary", Volzhsky

430032

"State Budgetary Healthcare Institution of Republic of Mordovia Republican Oncology Dispensary", Saransk

443031

"State Budgetary Healthcare Institution Samara Regional Clinical Oncology Dispensary (Chemotherapy Unit #1)", Samara

450054

"State Budgetary Healthcare Institution Republican Clinical Oncology Dispensary", Ufa

454091

"Non-State Healthcare Institution Railway Clinical Hospital at Chelyabinsk Station of Joint Stock Company Russian Railways", Chelyabinsk

460021

"State Budgetary Healthcare Institution Orenburg Regional Clinical Oncology Dispensary", Orenburg

603006

"State Budgetary Healthcare Institution of Nizhny Novgorod region Clinical Diagnostic centre", Nizhny Novgorod

603126

"State Budgetary Healthcare Institution of Nizhniy Novgorod Region Nizhniy Novgorod Regional Oncology Dispensary", Nizhny Novgorod

614066

"State Budgetary Healthcare Institution of Perm Territory Perm Territorial Oncology Dispensary", Perm

644013

"Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary", Omsk

Unknown

"Specialized Hospital for Active Treatment of Oncology Diseases - Sofia city EOOD", Sofia

"Specialized Hospital for Active Treatment ofOncologal Diseases - Sofia District", Sofia

"State Budgetary Healthcare Institution City Clinical Hospital #40 of the Healthcare Department of Moscow", Moscow

"State Budgetary Healthcare Institution of Moscow Moscow City Oncology Hospital #62 of Healthcare Department of Moscow", Moscow

"Research Institute of Pulmonology of State Budgetary Educational Institution of Higher Professional Education First Saint Petersburg State Medical University named after Academician I.P. Pavlov of the Ministry of Healthcare of the Russian Federation", Saint Petersburg

"State Budgetary Healthcare Institution Saint Petersburg Clinical Theoretical & Practical Centre of Special Types of Medical Care (Oncology)", Saint Petersburg

"Communal Institution Chernivtsi Regional clinical oncology dispensary", Chernivtsi

63-100

Centrum Medyczne Malgorzata, Gmina Śrem

35-922

Centrum Medyczne MrukMed, Rzeszów

87-100

Wojewódzki Szpital Zespolony im. Rydygiera, Torun

03115

Kyiv City Clinical Oncological Center, Kyiv

Sponsors
All Listed Sponsors
collaborator

Chiltern International Inc.

INDUSTRY

lead

Helsinn Healthcare SA

INDUSTRY