Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories

PHASE3CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

December 10, 2020

Primary Completion Date

July 16, 2024

Study Completion Date

September 19, 2024

Conditions
Ulcerative Proctitis
Interventions
COMBINATION_PRODUCT

Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator

Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator

COMBINATION_PRODUCT

Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator

Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator

COMBINATION_PRODUCT

Twice daily placebo suppository administered with Sephure applicator

Twice daily placebo suppository administered with Sephure applicator

Trial Locations (189)

144

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Tbilisi

186

"LTD Multi-Profile Clinic Consilium Medulla", Tbilisi

1000

Manila Doctors Hospital, Manila

1100

Saint George Hospital University Medical Center, Beirut

1101

National Kidney and Transplant Institute, Quezon City

1229

Makati Medical Center, Makati City

1300

Nini Hospital, Tripoli

1407

Medical Center Excelsior 2, Sofia

Medical Center Excelsior, Sofia

1500

Worthwhile Clinical Trials, Benoni

1502

Cardinal Santos Medical Center (CSMC), San Juan City

1527

University Hospital Tsaritsa Yoanna-ISUL, Sofia

1600

Hammoud Hospital University Medical Center, Sidon

1605

The Medical City Ortigas, Pasig

2023

The Medical City Clark, Mabalacat

2193

Wits Clinical Research, Johannesburg

2650

Hvidovre Hospital, Hvidovre

4000

Hospital Sveti Panteleimon, Plovdiv

4003

Medical Center Hipokrat - H, Plovdiv

4600

Zealand University Hospital, Koge, Køge

"JSC,, Vian", Kutaisi

5000

The Medical City Iloilo, Iloilo City

West Visayas State University Medical Center, Iloilo City

6000

Cebu Doctors' University Hospital, Cebu City

7800

Inspired GI Care, Cape Town

8801

LTD Diagnostic Consultative Center 1, Sliven

9000

Aalborg University Hospital, Aalborg

10000

103 Military Hospital, Hanoi

Bach Mai Hospital, Hanoi

Hanoi Medical University Hospital, Hanoi

Viet Duc Hospital, Hanoi

Vinmec Hospital, Hanoi

10003

"Limited Liability Company Medibor", Zhytomyr

10128

A.O. Ordine Mauriziano di Torino, Torino

10318

Praxis Dr. Michael R. Mross, Berlin

10512

Westchester Putnam Gastro, Carmel

11183

Al Khalidi Hospital and Medical Center, Amman

11184

Istishari Hospital, Amman

11194

The Specialty Hospital Advanced Clinical Center, Amman

11196

Istiklal Hospital, Amman

11426

National Guard Hospital Riyadh, Riyadh

11525

King Fahad Medical City, Riyadh

11942

Jordan University Hospital, Amman

12372

King Khalid University Hospital, Riyadh

17110

Susquehanna Research Group, LLC, Harrisburg

18840

Guthrie Medical Group, PC, Sayre

21028

"Municipal non-profit enterprise M.I. Pyrogov Vinnytsya Regional Clinical Hospital of the Vinnytsya Regional Council; National Pirogov Memorial Medical University, Vinnytsya", Vinnytsia

21029

"Municipal non-profit enterprise Vinnytsya City Clinical Hospital №1; National Pirogov Memorial Medical University, Vinnytsya", Vinnytsia

21423

National Guard Hospital Jeddah, Jeddah

21589

King Abdulaziz University Hospital, Jeddah

22110

Irbid Specialty Hospital/Clinical Research Center, Irbid

Pharmaceutical Research Center/Jordan University of Science and Technology, Irbid

22411

Dr. Bilal Hotayt Gastroenterology, Beirut

25006

"Private Enterprise Private Manufacturing Company Acinus", Kropyvnytskyi

27260

Peters Medical Research, High Point

27612

M3 Wake Research, Inc, Raleigh

28006

Hospital La Princesa, Madrid

28040

Hospital Clínico San Carlos and Instituto de Investigación del Hospital Clínico San Carlos (IdISSC), Madrid

28942

Hospital Universitario de Fuenlabrada, Fuenlabrada

29601

Gastroenterology Associates, Greenville

29607

Gastro Associates of Greenville, Greenville

30097

One Health Research Clinic Atlanta, Johns Creek

31059

Hopital Rangueil, Toulouse

32763

Gastroenterology of Greater Orlando, Orange City

32807

Revival Clinical Research, Orlando

33032

Homestead Associates in Research, Miami

33110

Mersin Universitesi Tip Fakultesi, Gastroenteroloji, Mersin

33155

Rejuvaline Medical Research, Miami

33175

Ezy Medical Research, Co., Miami

US Associates In Research, Miami

33176

Gastro Health Research of Miami, Miami

33322

BRCR Global Clinical Research, Plantation

33614

International Center for Research, Tampa

34090

CHU Montpellier - Hopital Saint Eloi, Montpellier

34102

GI PROS Research, Naples

34741

I.H.S. Health, LLC, Kissimmee

34899

Marmara Universitesi Pendik Eğitim Araştırma Hastanesi, Gastroenteroloji, Istanbul

35010

Hospital Dr. Negrín, Las Palmas de Gran Canaria

35100

Ege Universitesi Tip Fakultesi Hastanesi, Gastroenteroloji, Izmir

35128

Ospedale di Padova, Padua

35801

Clinical Research Associates LLC, Huntsville

37170

CHU TOURS. Service d'hépato-Gastro-entérologie, Chambray-lès-Tours

37421

ClinSearch, LLC, Chattanooga

37663

Tri-Cities Gastroenterology, Kingsport

42270

CHU de Saint-Étienne, Saint-Priest-en-Jarez

44060

Great Lakes Gastroenterology Research, LLC, Mentor

45007

Hospital Virgen de la Salud, Toledo

45219

Gastro Health Research, Cincinnati

45805

NexGen Research, Lima

46002

Ternopil University Hospital, Ternopil

48047

Clinical Research Institute of Michigan, LLC, Chesterfield

48098

Clinical Research Institute of Michigan, Troy

48159

Gastro Campus Research GbR, Münster

48334

Revive Research Institute, Farmington Hills

49000

Hue Central Hospital, Huế

50701

Cedar Valley Medical Specialists, P.C., Waterloo

59037

CHU Lille - Hôpital Claude Huriez, Lille

60062

Comprehensive Gastrointestinal Health, LLC, Northbrook

61037

"Municipal non-profit enterprise Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov of Kharkiv City Council", Kharkiv

61080

Karadeniz Teknik Üniversitesi Tıp Fakütesi Hastanesi Gastroenteroloji, Trabzon

65025

"Municipal non-profit enterprise Odesa Regional Clinical Hospital of the Odesa Regional Council, Regional Gastroenterological Center", Odesa

66111

Zentrum für Gastroenterologie Saar MVZ GmbH, Saarbrücken

69495

Hôpital Lyon Sud - HCL, Pierre-Bénite

70000

115 People's Hospital, Ho Chi Minh City

Cho Ray Hospital, Ho Chi Minh City

Gia Dinh People's Hospital, Ho Chi Minh City

Nguyen Tri Phuong Hospital, Ho Chi Minh City

70124

Ospedale: Azienda Policlinico Universitario Bari, Bari

70503

Combined Gastro LLC, Lafayette

75092

Medrasa Clinical, Sherman

77043

Dr. Mouhamad R. Al-Sabbagh, Houston

77077

Elixir Research Group, Houston

77204

Digestive Health Associates, Houston

77379

Spring Gastroenterology Associates, Spring

77386

Texas Gastroenterology Associates, Spring

77429

Allied Digestive Disease Center, Cypress

77502

Aspira International, Pasadena

77584

LINQ Research LLC, Pearland

78229

Southern Star Research Institute, LLC., San Antonio

79010

"Comunal NonCommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital", Lviv

80138

"Università della Campania Luigi Vanvitelli", Napoli

84088

Velocity Clinical Research/Gut Whisperer, West Jordan

90045

Southern CA Research Institute Medical Group/W Gastroenterology Medical Group, Los Angeles

91324

California Medical Research Associates Inc, Northridge

92020

Precision Research, El Cajon

92103

Clinical Applications Laboratories Inc, San Diego

92307

Om Research, Apple Valley

92663

Cornell Medical Research, Newport Beach

93012

Om Research, Camarillo

93534

Om Research, Lancaster

110017

Pushpawati Singhania Research Institute, New Delhi

110060

Sir Ganga Ram Hospital,, Delhi

191015

"Federal State Budgetary Military Educational Institution of Higher Education Military and Medical Academy named after S.M. Kirov of the Ministry of Defence of the Russian Federation; 2nd Therapy Chair for Advanced Training of Physicians", Saint Petersburg

"Federal State Budgetary Military Educational Institution of Higher Education Military and Medical Academy named after S.M. Kirov of the Ministry of Defense of the Russian Federation; Chair and Clinic of Hospital Therapy n. a. Professor V.N. Sirotinin", Saint Petersburg

197110

LLC 'Polyclinic EXPERT', Saint Petersburg

199226

Federal State Budgetary Educational Institution of Higher Education Saint Petersburg State University, Clinic of advanced medical technologies n.a. Nicolay I. Pirogov, Saint Petersburg

214019

"Regional State Budgetary Institution of Health Clinical Hospital №1", Smolensk

302004

SMS Medical College & Hospital, Jaipur

380015

Ahmedabad Bariatrics & Cosmetics Private Limited (Asian Bariatrics), Ahmedabad

ICON Hospital, Ahmedabad

380051

Sanjivani Superspeciality Hospital, Ahmedabad

390039

"SBI of HE Ryazan State Medical University n.a. ac. I.P. Pavlov of the MoH of the RF on the base of the SBI of the Ryazan Region Regional Clinical Hospital", Ryazan

395009

Gujarat Gastro and Vascular Hospital, Surat

400022

Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital, Mumbai

400394

"Regional Institute of Gastroenterology and Hepatology Prof. Dr. Octavian Fodor Cluj-Napoca", Cluj-Napoca

410071

"State Budgetary Healthcare Institution Saratov City Clinical Hospital # 5", Saratov

411001

B.J. Government Medical College and Sassoon General Hospital, Pune

411033

Ashwin Medical Foundation Multispeciality Hospital, Pune

440010

Midas Institute of Gastroenterology, Nagpur

442004

Acharya Vinoba Bhave Rural Hospital, Wardha

540103

Tirgu-Mures Country Clinical Hospital, Târgu Mureş

600026

SIMS Hospital, Chennai

707401

Gastromedical SRL, Iași

07018

Sanmora Bespoke Clinical Research Solutions, LLC., East Orange

Unknown

Alice Ho Miu Ling Nethersole Hospital, Hong Kong

Humanity & Health Clinical Trial Centre, Hong Kong

Queen Mary Hospital, Hong Kong

Tuen Mun Hospital, Hong Kong

St. Luke's Medical Center, Quezon City

Centrul de Gastroenterologie Dr. Goldis, Timișoara

0160

"LTD Aversi Clinic", Tbilisi

06108

Studiengesellschaft BSF UG, Halle

04103

EuGastro GmbH, Leipzig

09042

Università di Cagliari, Dipartimento di Scienze mediche e sanità pubblica, Monserrato

MD 2025

Institutul de Cardiologie Consultative Department, RTL Clinic, Chisinau

"Republican Hospital Timofei Moșneaga, Consultative Department, Policlinic", Chisinau

67-100

Twoja Przychodnia - Centrum Medyczne Nowa Sol, Nowa Sól

71-434

Uromed Jakub Koteras Twoja Przychodnia- Szczecińskie Centrum Medyczne, Szczecin

85-079

Vitamed Galaj i Cichomski Sp.j., Bydgoszcz

85-794

Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak, Malgorzata Trzaska, Bydgoszcz

89-600

Centrum Medyczne Lukamed Joanna Luka Wendrowska, Chojnice

32-500

Centrum Medyczne MBB-MED, Chrzanów

86-300

Centrum Medyczne CLW-MED Aneta Cichomska, Joanna Luka-Wendrowska, Grudziądz

58-500

Karkonoskie Centrum Badan Klinicznych Lexmedica Sp. z o.o, Jelenia Góra

95-054

Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J., Ksawerów

91-495

AMICARE Sp. z o.o. sp. k., Lodz

35-302

Korczowski Bartosz, Gabinet Lekarski, Rzeszów

71-685

Sonomed Sp. z o.o., Szczecin

02-798

Medical Concierge Centrum Medyczne, Warsaw

04-501

Medical Network Spółka z o.o., Warsaw

50-449

Melita Medical Centrum Medyczne, Wroclaw

020125

Spitalul Clinic Colentina, Bucharest

020475

Spitalul Clinic 'Dr Ion Cantacuzino', Bucharest

022328

Clinical Institute Fundeni, Gastro Enterology Department No.2, Bucharest

050098

Spitalul Universitar de Urgenta Bucuresti, Bucharest

11223311159

Prince Sultan Military Medical City, Riyadh

0002

EMMED, Pretoria

07100

SBÜ. Antalya Eğirim ve Araştırma Hastanesi, Gastroenteroloji, Antalya

01030

"Municipal non-profit enterprise Kyiv City Clinical Hospital No. 18 of the executive body of the Kyiv City Council (Kyiv City State Administration)", Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Cristcot HCA LLC

INDUSTRY

lead

Cristcot LLC

INDUSTRY