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

Primary Purpose

Ulcerative Proctitis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
Twice daily placebo suppository administered with Sephure applicator
Sponsored by
Cristcot LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Proctitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or non pregnant, non lactating females aged 18 years and older.
  • Subjects with a confirmed diagnosis of active UC of the rectum, extending no more than 15 centimeters (cm) (5.9 inches) proximal to the anal verge as assessed by colonoscopy performed at Visit 2. Note: Subjects may have a history of more extensive UC (e.g., pancolitis), but have active disease only in the rectum at the time of enrollment.
  • Modified Mayo sub score for stool frequency of 1 3.
  • Modified Mayo sub score for rectal bleeding of 0 2.
  • Modified Mayo endoscopic sub score of 2 3.
  • Total Modified Mayo Score (without physician global assessment) of 3-8.

Exclusion Criteria:

  • History or current diagnosis of bacterial or other infectious colitis, radiation enteritis and radiation proctitis, Crohn's disease, collagenous colitis and indeterminate colitis.
  • Prior gastrointestinal surgery except appendectomy, cholecystectomy, and hernia.
  • Concomitant active lower gastrointestinal disease (except Irritable Bowel Syndrome) or distortion of intestinal anatomy.
  • Bleeding hemorrhoids at the time of enrollment.
  • Acute diverticulitis at the time of enrollment.
  • Acute or chronic pancreatitis at the time of enrollment.
  • Unmanaged celiac disease at the time of enrollment.
  • Positive stool test for enteric pathogens, Clostridium difficile, or presence of ova and parasites.
  • Taking a prohibited medication.

Sites / Locations

  • Clinical Research Associates LLCRecruiting
  • Om ResearchRecruiting
  • Om ResearchRecruiting
  • Om ResearchRecruiting
  • Precision ResearchRecruiting
  • Clinical Applications LaboratoriesRecruiting
  • Homestead Associates in ResearchRecruiting
  • Rejuvaline Medical ResearchRecruiting
  • US Associates in ResearchRecruiting
  • GI PROs ResearchRecruiting
  • Revival Clinical ResearchRecruiting
  • International Center for ResearchRecruiting
  • One Health Research Clinic AtlantaRecruiting
  • Clinical Research Institute of MichiganRecruiting
  • Revive Research InstituteRecruiting
  • Clinical Research of MichiganRecruiting
  • Sanmora Bespoke Clinical ResearchRecruiting
  • Ohio Gastroenterology & Liver InstituteRecruiting
  • Great Lakes Gastroenterology Research, LLCRecruiting
  • Dr. Mouhamed Al-SabbaghRecruiting
  • Southern Star Research InstituteRecruiting
  • Texas Gastroenterology Associates (A1 Clinical)Recruiting
  • Aalborg University HospitalRecruiting
  • Hvidovre HospitalRecruiting
  • Zealand University HospitalRecruiting
  • Studiengesellschaft BSF UGRecruiting
  • EuGastro GmbHRecruiting
  • ICON HospitalRecruiting
  • Ashwin Medical Foundation Multispeciality HospitalRecruiting
  • Acharya Vinoba Bhave Rural HospitalRecruiting
  • Max Smart Super Speciality Hospital
  • SMS Medical College & HospitalRecruiting
  • SIMS HospitalRecruiting
  • Ospedale: Azienda Policlinico Universitario BariRecruiting
  • Università di Cagliari, Dipartimento di Scienze mediche e sanità pubblicaRecruiting
  • University della Campania 'Luigi Vanvitelli'
  • Hospital da PadovaRecruiting
  • A.O. Ordine Mauriziano di TorinoRecruiting
  • Cebu Doctors' University HospitalRecruiting
  • The Medical City IloiloRecruiting
  • West Visayas State University Medical CenterRecruiting
  • Makati Medical CenterRecruiting
  • National Kidney and Transplant InstituteRecruiting
  • St. Luke's Medical CenterRecruiting
  • Cardinal Santos Medical Center (CSMC)Recruiting
  • The Medical City ClarkRecruiting
  • Manila Doctors HospitalRecruiting
  • The Medical City OrtigasRecruiting
  • Uromed Jakub Koteras Twoja Przychodnia- Szczecińskie Centrum MedyczneRecruiting
  • Vitamed Galaj i Cichomski Sp.j.Recruiting
  • Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak, Malgorzata TrzaskaRecruiting
  • Centrum Medyczne Lukamed Joanna Luka WendrowskaRecruiting
  • Centrum Medyczne MBB-MEDRecruiting
  • Centrum Medyczne CLQ-MEDRecruiting
  • Karkonoskie Centrum Badan Klinicznych Lexmedica Sp. z o.oRecruiting
  • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.Recruiting
  • Twoja Przychodnia - Centrum Medyczne Nowa SolRecruiting
  • Korczowski Bartosz, Gabinet LekarskiRecruiting
  • Sonomed Sp. z o.o.Recruiting
  • WIP Warsaw IBD Point Prof. KierkusRecruiting
  • Medical Concierge Centrum MedyczneRecruiting
  • Melita Medical Centrum MedyczneRecruiting
  • AmicareRecruiting
  • Spitalul Clinic ColentinaRecruiting
  • Spitalul Clinic 'Dr Ion Cantacuzino'Recruiting
  • IC Fundeni 2 Gastro enterology departmentRecruiting
  • Spitalul Universitar de Urgenta BucurestiRecruiting
  • Regional Institute of GastroenterologyRecruiting
  • Gastromedical SRLRecruiting
  • Centrul de Gastroenterologie Dr. GoldisRecruiting
  • Tirgu-Mures Country Clinical HospitalRecruiting
  • Worthwhile Clinical TrialsRecruiting
  • Inspired GI CareRecruiting
  • Wits Clinical ResearchRecruiting
  • EMMEDRecruiting
  • Hospital Virgen de la SaludRecruiting
  • Hospital Dr. NegrínRecruiting
  • Hospital Universitario de FuenlabradaRecruiting
  • Hospital La PrincesaRecruiting
  • Hospital Clinico San Carlos and Instituto de Investigacion del Hospital Clinico San CarlosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Twice Daily - Active

Once Daily - Active

Placebo

Arm Description

Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator

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

Twice daily placebo suppository administered with Sephure suppository applicator

Outcomes

Primary Outcome Measures

Clinical remission measured using the Modified Mayo Score
To evaluate the the efficacy of two dosage regimens of the study drug

Secondary Outcome Measures

Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency
To assess the change in stool frequency
Rectal bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to 0
To assess the change in rectal bleeding

Full Information

First Posted
July 2, 2020
Last Updated
August 28, 2023
Sponsor
Cristcot LLC
Collaborators
Cristcot HCA LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04469686
Brief Title
Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories
Official Title
3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Applicator in Subjects With Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cristcot LLC
Collaborators
Cristcot HCA LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized, multi-center, double-blind, three arm placebo-controlled study in male and non-pregnant, non-lactating female subjects aged 18 years to examine the safety and efficacy of two dosing regimens of hydrocortisone acetate 90 mg suppository administered with the Sephure applicator for the treatment of ulcerative colitis of the rectum.
Detailed Description
Hydrocortisone acetate 90 mg or placebo will be administered as a rectal suppository with a Sephure suppository applicator. Two arms of the study will receive different dosage regimens of hydrocortisone acetate, and the third arm will receive placebo. All subjects will administer the study drug twice a day; once in the morning and once in the evening for 28 days. The study population will consist of male and non pregnant, non lactating females aged 18 years and older with a confirmed diagnosis of active UC of the rectum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Proctitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
618 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Twice Daily - Active
Arm Type
Experimental
Arm Description
Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator
Arm Title
Once Daily - Active
Arm Type
Experimental
Arm Description
Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Twice daily placebo suppository administered with Sephure suppository applicator
Intervention Type
Combination Product
Intervention Name(s)
Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
Other Intervention Name(s)
Twice Daily - Active
Intervention Description
Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
Intervention Type
Combination Product
Intervention Name(s)
Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
Other Intervention Name(s)
Once Daily - Active
Intervention Description
Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
Intervention Type
Combination Product
Intervention Name(s)
Twice daily placebo suppository administered with Sephure applicator
Other Intervention Name(s)
Twice Daily - Placebo
Intervention Description
Twice daily placebo suppository administered with Sephure applicator
Primary Outcome Measure Information:
Title
Clinical remission measured using the Modified Mayo Score
Description
To evaluate the the efficacy of two dosage regimens of the study drug
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency
Description
To assess the change in stool frequency
Time Frame
28 days
Title
Rectal bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to 0
Description
To assess the change in rectal bleeding
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Quality of Life assessed measured using IBDQ validated questionnaire
Description
To examine the quality of life of patients
Time Frame
28 days
Title
Grading of disease severity measure using Mayo Scoring sub-score of Physician's Global Assessment
Description
To assess disease severity
Time Frame
28 days
Title
Concentrations of hydrocortisone acetate using pharmacokinetic sampling
Description
To evaluate the exposure of hydrocortisone acetate levels for safety
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or non pregnant, non lactating females aged 18 years and older. Subjects with a confirmed diagnosis of active UC of the rectum, extending no more than 15 centimeters (cm) (5.9 inches) proximal to the anal verge as assessed by colonoscopy performed at Visit 2. Note: Subjects may have a history of more extensive UC (e.g., pancolitis), but have active disease only in the rectum at the time of enrollment. Modified Mayo sub score for stool frequency of 1 3. Modified Mayo sub score for rectal bleeding of 0 2. Modified Mayo endoscopic sub score of 2 3. Total Modified Mayo Score (without physician global assessment) of 4-8. Exclusion Criteria: History or current diagnosis of bacterial or other infectious colitis, radiation enteritis and radiation proctitis, Crohn's disease, collagenous colitis and indeterminate colitis. Prior gastrointestinal surgery except appendectomy, cholecystectomy, and hernia. Concomitant active lower gastrointestinal disease (except Irritable Bowel Syndrome) or distortion of intestinal anatomy. Bleeding hemorrhoids at the time of enrollment. Acute diverticulitis at the time of enrollment. Acute or chronic pancreatitis at the time of enrollment. Unmanaged celiac disease at the time of enrollment. Positive stool test for enteric pathogens, Clostridium difficile, or presence of ova and parasites. Taking a prohibited medication.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark C Ensign
Phone
978-212-6380
Email
mark.ensign@cristcot.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lead Scientist
Phone
978-212-6380
Email
research@cessa-uc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karthik Devarajan, MD
Organizational Affiliation
Cristcot LLC
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Associates LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peg Rochina
Phone
256-536-6600
Facility Name
Om Research
City
Apple Valley
State/Province
California
ZIP/Postal Code
92307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neera Grover
Facility Name
Om Research
City
Camarillo
State/Province
California
ZIP/Postal Code
93012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Simon
Facility Name
Om Research
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jatinder Pruthi
Facility Name
Precision Research
City
San Diego
State/Province
California
ZIP/Postal Code
92020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlton Thomas
Facility Name
Clinical Applications Laboratories
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vijaya Pratha
Facility Name
Homestead Associates in Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenia Atienzo
First Name & Middle Initial & Last Name & Degree
Jhenny Grullon
Facility Name
Rejuvaline Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunaiky Rivera
Facility Name
US Associates in Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilberto Seco
Facility Name
GI PROs Research
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Phillips
Facility Name
Revival Clinical Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seela Ramesh
Facility Name
International Center for Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angel Rosario
Facility Name
One Health Research Clinic Atlanta
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvia Fischer
Facility Name
Clinical Research Institute of Michigan
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karie Simons
Facility Name
Revive Research Institute
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Obianuju Lindia Ogbonna
Facility Name
Clinical Research of Michigan
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Partha Nandi
Facility Name
Sanmora Bespoke Clinical Research
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adigun Rotimi
Phone
973-676-1920
Facility Name
Ohio Gastroenterology & Liver Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pradeep K Bekal
Facility Name
Great Lakes Gastroenterology Research, LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brooke Adamic, SN
Facility Name
Dr. Mouhamed Al-Sabbagh
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mouhamed Al-Sabbagh
Facility Name
Southern Star Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garza Mireya
Phone
210-581-2812
Facility Name
Texas Gastroenterology Associates (A1 Clinical)
City
Spring
State/Province
Texas
ZIP/Postal Code
77386
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Schumyla Iftykhar
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Fallingborg
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida Vind
Facility Name
Zealand University Hospital
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Vester-Anderson
Facility Name
Studiengesellschaft BSF UG
City
Halle
ZIP/Postal Code
06108
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karolina Winkler
Facility Name
EuGastro GmbH
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne Maybaum
Facility Name
ICON Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manish Bhatnagar
Facility Name
Ashwin Medical Foundation Multispeciality Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411033
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aditi Wad
Facility Name
Acharya Vinoba Bhave Rural Hospital
City
Wardha
State/Province
Maharashtra
ZIP/Postal Code
442004
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priyanka Kawale
Facility Name
Max Smart Super Speciality Hospital
City
Saket
State/Province
New Delhi
ZIP/Postal Code
100017
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jyoti Dhiman
Facility Name
SMS Medical College & Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rakesh Saini
Facility Name
SIMS Hospital
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600026
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manisha M
First Name & Middle Initial & Last Name & Degree
Srinivas Vedantha
Facility Name
Ospedale: Azienda Policlinico Universitario Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeria Suriano, MS
Facility Name
Università di Cagliari, Dipartimento di Scienze mediche e sanità pubblica
City
Cagliari
ZIP/Postal Code
09042
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Pinto
Facility Name
University della Campania 'Luigi Vanvitelli'
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnese Miranda, MD
First Name & Middle Initial & Last Name & Degree
Lucia Granata, MD
Facility Name
Hospital da Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Greta Lorenzon
First Name & Middle Initial & Last Name & Degree
Alessandra Rigo
Facility Name
A.O. Ordine Mauriziano di Torino
City
Torino
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Guiotto
Facility Name
Cebu Doctors' University Hospital
City
Cebu City
State/Province
Cebu
ZIP/Postal Code
6000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louisse Noelle Prile
Facility Name
The Medical City Iloilo
City
Iloilo City
State/Province
Iloilo
ZIP/Postal Code
5000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Webster Padernal
First Name & Middle Initial & Last Name & Degree
Bea Nestie Angeli Villareal
Facility Name
West Visayas State University Medical Center
City
Iloilo City
State/Province
Iloilo
ZIP/Postal Code
5000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clement Cezar Suñer, MD
Facility Name
Makati Medical Center
City
Makati City
State/Province
Metro Manila
ZIP/Postal Code
1229
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joyce Anne Calulut
First Name & Middle Initial & Last Name & Degree
Joshua Allan Atienza
Facility Name
National Kidney and Transplant Institute
City
Quezon City
State/Province
Metro Manila
ZIP/Postal Code
1101
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Demetriou, RN
Facility Name
St. Luke's Medical Center
City
Quezon City
State/Province
Metro Manila
ZIP/Postal Code
1112
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiela Calces
First Name & Middle Initial & Last Name & Degree
Lorraine Pelingen
Facility Name
Cardinal Santos Medical Center (CSMC)
City
San Juan
State/Province
Metro Manila
ZIP/Postal Code
1502
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marites Obra
First Name & Middle Initial & Last Name & Degree
Maria Lidda Dacanay
Facility Name
The Medical City Clark
City
Mabalacat
State/Province
Pampanga
ZIP/Postal Code
2023
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaye Ann Casulla
Facility Name
Manila Doctors Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Sapelino
Phone
639189309218
Facility Name
The Medical City Ortigas
City
Manila
ZIP/Postal Code
1605
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abherdyn Caballero
Phone
63178686448
Facility Name
Uromed Jakub Koteras Twoja Przychodnia- Szczecińskie Centrum Medyczne
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
71434
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jakub Jaszczak, MSc.
First Name & Middle Initial & Last Name & Degree
Natalia Nowazyk, MSc.
Facility Name
Vitamed Galaj i Cichomski Sp.j.
City
Bydgoszcz
ZIP/Postal Code
85079
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafal Cichomski, MSc.
Facility Name
Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak, Malgorzata Trzaska
City
Bydgoszcz
ZIP/Postal Code
85794
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewa Galczak-Nowak, MSc.
First Name & Middle Initial & Last Name & Degree
Natalia Ostojska
Facility Name
Centrum Medyczne Lukamed Joanna Luka Wendrowska
City
Chojnice
ZIP/Postal Code
89600
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna Luka-Wendrowska, MSC
First Name & Middle Initial & Last Name & Degree
Aleksandra Niemczyk
Facility Name
Centrum Medyczne MBB-MED
City
Chrzanów
ZIP/Postal Code
32500
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaroslaw Bigij
Facility Name
Centrum Medyczne CLQ-MED
City
Grudziądz
ZIP/Postal Code
86300
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dariusz Gajda
Facility Name
Karkonoskie Centrum Badan Klinicznych Lexmedica Sp. z o.o
City
Jelenia Góra
ZIP/Postal Code
58500
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Durbajlo-Gradziel, MSc.
First Name & Middle Initial & Last Name & Degree
Justyna Lis, MSc.
Facility Name
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
City
Ksawerów
ZIP/Postal Code
95054
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Fortak-Michalska, MD
Facility Name
Twoja Przychodnia - Centrum Medyczne Nowa Sol
City
Nowa Sól
ZIP/Postal Code
67100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnieszka Antczak-Krawczyk, MSc.
Facility Name
Korczowski Bartosz, Gabinet Lekarski
City
Rzeszów
ZIP/Postal Code
35-302
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Trela
Facility Name
Sonomed Sp. z o.o.
City
Szczecin
ZIP/Postal Code
71685
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomasz Kwiecień
First Name & Middle Initial & Last Name & Degree
Joanna Wasylów
Facility Name
WIP Warsaw IBD Point Prof. Kierkus
City
Warszawa
ZIP/Postal Code
00728
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Baros
First Name & Middle Initial & Last Name & Degree
Joanna Blaszczak
Facility Name
Medical Concierge Centrum Medyczne
City
Warszawa
ZIP/Postal Code
02798
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Artur Lamparski, MSc.
First Name & Middle Initial & Last Name & Degree
Kamila Lewińska
Facility Name
Melita Medical Centrum Medyczne
City
Wrocław
ZIP/Postal Code
50449
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Kijora-Jaroszewska
First Name & Middle Initial & Last Name & Degree
Lech Kula
Facility Name
Amicare
City
Łódź
ZIP/Postal Code
91495
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafal Drozda
Facility Name
Spitalul Clinic Colentina
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radu Gogdan Mateescu, MD
Facility Name
Spitalul Clinic 'Dr Ion Cantacuzino'
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marilena Stoian
Facility Name
IC Fundeni 2 Gastro enterology department
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Preda
Facility Name
Spitalul Universitar de Urgenta Bucuresti
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucian Negreanu, MD, PhD
Facility Name
Regional Institute of Gastroenterology
City
Cluj-Napoca
ZIP/Postal Code
400162
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Pojoga
Facility Name
Gastromedical SRL
City
Iaşi
ZIP/Postal Code
707401
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anca Trifan
Facility Name
Centrul de Gastroenterologie Dr. Goldis
City
Timişoara
ZIP/Postal Code
300001
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian Goldis
Facility Name
Tirgu-Mures Country Clinical Hospital
City
Târgu-Mureş
ZIP/Postal Code
540103
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Dobru
Facility Name
Worthwhile Clinical Trials
City
Benoni
ZIP/Postal Code
1500
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nazreen Hussen
Facility Name
Inspired GI Care
City
Cape Town
ZIP/Postal Code
7800
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naayil Rajabally
Facility Name
Wits Clinical Research
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manoko Seabi
Facility Name
EMMED
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johannes Breedt
Facility Name
Hospital Virgen de la Salud
City
Toledo
State/Province
Castilla La-Mancha
ZIP/Postal Code
45004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Almudena Garcia Vela
Facility Name
Hospital Dr. Negrín
City
Las Palmas De Gran Canaria
State/Province
Islas Canarias
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Cebalios Santos, MD
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Jimenez Marquez
Facility Name
Hospital La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Hermida
First Name & Middle Initial & Last Name & Degree
Diana Acosta
Facility Name
Hospital Clinico San Carlos and Instituto de Investigacion del Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Olivares

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cessa-uc.com
Description
A clinical study to evaluate the safety and effectiveness of an investigational hydrocortisone acetate 90 mg suppository administered with the Sephure applicator for the treatment of moderate to severe ulcerative colitis

Learn more about this trial

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

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