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Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis

Primary Purpose

Proctitis, Ulcerative

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MAX-002
Placebo
Canasa®
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proctitis, Ulcerative focused on measuring Ulcerative proctitis, Proctocolitis, Inflammatory Bowel Disease, Gastrointestinal Diseases, Colonic Diseases, Mesalamine, 5-ASA

Eligibility Criteria

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

Inclusion Criteria:

  • Participants who are 18 years old or older
  • Participants with total Mayo DAI score between 5 to 10 at Screening and participants with score of 2 or more for the rectal bleeding and for the findings of flexible proctosigmoidoscopy or colonoscopy sub-scores of the Mayo DAI
  • Participants with confirmed mild to moderate active UP not extending above rectum as evidenced by flexible proctosigmoidoscopy and histopathology assessments
  • Female participants of child-bearing age who have negative serum beta-human chorionic gonadotropin (β-HCG) at the time of entry into the study
  • Female participants of child-bearing age who use medically acceptable form of birth control
  • Participants who are smokers and non-smokers must not change their smoking habits or nicotine use during the DB treatment period
  • Participants who are literate and have legal ability to sign informed consent form

Exclusion Criteria:

  • Participants with other digestive diseases interfering with the measurement of any sub-score of the Mayo DAI
  • Participants with known presence or suspicion of malignant disease of the digestive system or presence or history of neoplasms other than carcinoma in situ of the cervix or basal carcinoma of the skin
  • Participants with clinically significant electrocardiographic abnormalities that would compromise its participation in the study
  • Participants who are chronically using oral 5-aminosalicylic acid (5-ASA) at a dose greater than 4g daily, change in the oral 5-ASA dosing, or use of any form of rectal 5-ASA formulations during the 30 days prior to randomization
  • Participants with significant use of corticosteroids ,immunosuppressant's or biologic response modifiers that may have a therapeutic effect on ulcerative proctitis during the 45 days before the date of consent
  • Participants who use any rectally administered medicine during the 30 days prior to randomization
  • Participants who have contraindication to the use of mesalamine or suppository vehicle, analgesia, flexible proctosigmoidoscopy or colonoscopy
  • Participants who have blood parameters of grade 3 or higher on the common terminology criteria for adverse events (CTCAE) 5-point scale
  • Participants with severe renal or hepatic impairment with parameters of grade 3 or higher on the CTCAE
  • Participants with clinically significant urinary tract obstruction and history of idiopathic pancreatitis
  • Participants with presence of other known clinically significant medical and/or psychological illnesses precluding participation
  • Participants who participate in clinical studies other than observational studies during the 90 days before the date of the informed consent form signature
  • Participants who are unable or unwilling to complete the follow-up evaluations required for the study

Sites / Locations

  • Birmingham Gastroenterology Associates P.C.
  • Digestive Health Specialists of the Southeast
  • Desert Sun Gastroenterology
  • Rocky Mountain Gastroenterology Associates
  • Litchfield County Gastroenterology and Associates
  • Clinical Research of South Florida
  • Center for Gastrointestinal Disorders
  • Gastroenterology Group of Naples
  • Shafran Gastroenterology Center
  • Digestive Research Associates
  • Advanced Pain Care Clinic
  • Gastrointestinal Associates
  • Center for Digestive & Liver Diseases Inc.
  • South Jersey Gastroenterology
  • Synergy First Medical
  • Research Associates of New York (RANY)
  • Consultants for Clinical Research
  • Cleveland Clinic
  • Memphis Gastroenterology Group
  • The First Clinic
  • South Texas Research Alliance
  • Wisconsin Center for Advanced Research
  • Gastroenterology & Hepatology Clinic
  • Diamond Health Care Centre
  • Surrey GI Clinic Research
  • St-Joseph's Healthcare Hamilton
  • DHC Research
  • Toronto Digestive Disease Associates Inc. (TDDA)
  • Hôpital Maisonneuve-Rosemont
  • Alpha Recherche Clinique
  • GASTROMED s.c.
  • Wojewódzki Szpital Specjalistyczny Oddz. Gastroenterologii
  • SPZOZ Uniwersytecki Szpital Kliniczny
  • SPZOZ Uniwersytecki Szpital Kliniczny
  • Wojewodzki Szpital Specjalistyczny
  • SP Szpital Kliniczny
  • Szpital Kolejowy
  • MEDICOR - Centrum Medyczne
  • Endoskopia SP. Z o.o.
  • Gabinet Lekarski LECHMED

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

MAX-002

Placebo

Canasa®

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Who Were Responders at Week 6
Participants were considered as responders if they had total Mayo Disease Activity Index (DAI) score less than 3 points and no individual sub-scores greater than or equal to 2. Mayo DAI is a semi-quantitative scale which consists of 4 sub-scales: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy or colonoscopy and physician global assessment, each sub-scale ranged from 0 to 3 (0=normal, 3=severe). The total Mayo DAI score ranges from 0 (normal or inactive disease) to 12 (severe disease).

Secondary Outcome Measures

Percentage of Participants Who Were Responders at Week 3
Participants considered as responders if they had total Mayo DAI score less than 3 points and no individual sub-scores greater than or equal to 2. Mayo DAI is a semi-quantitative scale which consists of 4 sub-scales: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy or colonoscopy and physician global assessment, each sub-scale ranged from 0 to 3 (0=normal, 3=severe). The total Mayo DAI score ranges from 0 (normal or inactive disease) to 12 (severe disease).
Time to Relief of Rectal Bleeding
Time to relief of rectal bleeding was defined as number of days from randomization (Day 1) up to the first date of 3 consecutive days without observation of rectal bleeding during the double-blind phase.
Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6
The IBDQ is used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 domains of wellness: bowel symptoms (10 questions), systemic symptoms (5 questions), social symptoms (5 questions) and emotional function (12 questions). The response to each question is graded on 7-point likert scale, ranging from 1 (worst aspect) to 7 (best aspect). The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges from 32 to 224 with higher scores indicating a better quality of life.
Time to Relief of Tenesmus
Time to relief of tenesmus (feeling of constantly needing to pass stools, even if the bowels are already empty) was defined as the number of days from randomization (Day 1) up to the first date of 3 consecutive days without observation of tenesmus during the double-blind phase.

Full Information

First Posted
November 17, 2009
Last Updated
August 23, 2019
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01016262
Brief Title
Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
Official Title
A Multicenter, Double-blind, Controlled, Randomized, Parallel Group Comparison Phase IIIa Treatment Investigation on the Efficacy and Safety of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
The decision was taken solely for business/administrative reasons, no safety considerations entered into this. Ongoing randomized patients to complete.
Study Start Date
November 30, 2009 (Actual)
Primary Completion Date
July 31, 2011 (Actual)
Study Completion Date
September 30, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, multicenter, double-blind (DB), controlled, randomized, parallel group comparison Phase 3a study to evaluate the efficacy and safety of new mesalamine suppositories (MAX-002) as compared to placebo and active medicine after 6 weeks of treatment in adults with mild to moderate ulcerative proctitis (UP).
Detailed Description
The present study consists of screening period (2 weeks before randomization), DB phase (6 weeks), OL phase (8 weeks) and follow-up visits at Week 3, Week 6 and Week 14. Participants who are eligible will be randomized to receive 1g MAX-002, 1g Canasa® and placebo suppository once daily in the DB phase. Participants who complete or discontinue the study at Week 6 will either receive 1g MAX-002 suppositories on a voluntary basis, standard care treatment as per investigator's discretion or no treatment during the next 8 weeks of the OL phase. Total duration of treatment will be of 14 weeks. Efficacy will primarily be evaluated by percentage of participants who show response as per Mayo DAI Score at Week 6. Participants' safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proctitis, Ulcerative
Keywords
Ulcerative proctitis, Proctocolitis, Inflammatory Bowel Disease, Gastrointestinal Diseases, Colonic Diseases, Mesalamine, 5-ASA

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
MAX-002
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Canasa®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
MAX-002
Other Intervention Name(s)
Mesalamine
Intervention Description
MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the open-label (OL) phase.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
Intervention Type
Drug
Intervention Name(s)
Canasa®
Other Intervention Name(s)
Mesalamine
Intervention Description
Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Were Responders at Week 6
Description
Participants were considered as responders if they had total Mayo Disease Activity Index (DAI) score less than 3 points and no individual sub-scores greater than or equal to 2. Mayo DAI is a semi-quantitative scale which consists of 4 sub-scales: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy or colonoscopy and physician global assessment, each sub-scale ranged from 0 to 3 (0=normal, 3=severe). The total Mayo DAI score ranges from 0 (normal or inactive disease) to 12 (severe disease).
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Were Responders at Week 3
Description
Participants considered as responders if they had total Mayo DAI score less than 3 points and no individual sub-scores greater than or equal to 2. Mayo DAI is a semi-quantitative scale which consists of 4 sub-scales: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy or colonoscopy and physician global assessment, each sub-scale ranged from 0 to 3 (0=normal, 3=severe). The total Mayo DAI score ranges from 0 (normal or inactive disease) to 12 (severe disease).
Time Frame
Week 3
Title
Time to Relief of Rectal Bleeding
Description
Time to relief of rectal bleeding was defined as number of days from randomization (Day 1) up to the first date of 3 consecutive days without observation of rectal bleeding during the double-blind phase.
Time Frame
Day 1 up to Week 6
Title
Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6
Description
The IBDQ is used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 domains of wellness: bowel symptoms (10 questions), systemic symptoms (5 questions), social symptoms (5 questions) and emotional function (12 questions). The response to each question is graded on 7-point likert scale, ranging from 1 (worst aspect) to 7 (best aspect). The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges from 32 to 224 with higher scores indicating a better quality of life.
Time Frame
Baseline, Week 6
Title
Time to Relief of Tenesmus
Description
Time to relief of tenesmus (feeling of constantly needing to pass stools, even if the bowels are already empty) was defined as the number of days from randomization (Day 1) up to the first date of 3 consecutive days without observation of tenesmus during the double-blind phase.
Time Frame
Day 1 up to Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants who are 18 years old or older Participants with total Mayo DAI score between 5 to 10 at Screening and participants with score of 2 or more for the rectal bleeding and for the findings of flexible proctosigmoidoscopy or colonoscopy sub-scores of the Mayo DAI Participants with confirmed mild to moderate active UP not extending above rectum as evidenced by flexible proctosigmoidoscopy and histopathology assessments Female participants of child-bearing age who have negative serum beta-human chorionic gonadotropin (β-HCG) at the time of entry into the study Female participants of child-bearing age who use medically acceptable form of birth control Participants who are smokers and non-smokers must not change their smoking habits or nicotine use during the DB treatment period Participants who are literate and have legal ability to sign informed consent form Exclusion Criteria: Participants with other digestive diseases interfering with the measurement of any sub-score of the Mayo DAI Participants with known presence or suspicion of malignant disease of the digestive system or presence or history of neoplasms other than carcinoma in situ of the cervix or basal carcinoma of the skin Participants with clinically significant electrocardiographic abnormalities that would compromise its participation in the study Participants who are chronically using oral 5-aminosalicylic acid (5-ASA) at a dose greater than 4g daily, change in the oral 5-ASA dosing, or use of any form of rectal 5-ASA formulations during the 30 days prior to randomization Participants with significant use of corticosteroids ,immunosuppressant's or biologic response modifiers that may have a therapeutic effect on ulcerative proctitis during the 45 days before the date of consent Participants who use any rectally administered medicine during the 30 days prior to randomization Participants who have contraindication to the use of mesalamine or suppository vehicle, analgesia, flexible proctosigmoidoscopy or colonoscopy Participants who have blood parameters of grade 3 or higher on the common terminology criteria for adverse events (CTCAE) 5-point scale Participants with severe renal or hepatic impairment with parameters of grade 3 or higher on the CTCAE Participants with clinically significant urinary tract obstruction and history of idiopathic pancreatitis Participants with presence of other known clinically significant medical and/or psychological illnesses precluding participation Participants who participate in clinical studies other than observational studies during the 90 days before the date of the informed consent form signature Participants who are unable or unwilling to complete the follow-up evaluations required for the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aptalis Medical Information
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Gastroenterology Associates P.C.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Digestive Health Specialists of the Southeast
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Desert Sun Gastroenterology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Rocky Mountain Gastroenterology Associates
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
Litchfield County Gastroenterology and Associates
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Facility Name
Clinical Research of South Florida
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Center for Gastrointestinal Disorders
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Digestive Research Associates
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Advanced Pain Care Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Gastrointestinal Associates
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Center for Digestive & Liver Diseases Inc.
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
South Jersey Gastroenterology
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Synergy First Medical
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11230
Country
United States
Facility Name
Research Associates of New York (RANY)
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Memphis Gastroenterology Group
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
The First Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
South Texas Research Alliance
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Gastroenterology & Hepatology Clinic
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 3N5
Country
Canada
Facility Name
Diamond Health Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1N9
Country
Canada
Facility Name
Surrey GI Clinic Research
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1H 3R3
Country
Canada
Facility Name
St-Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
DHC Research
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 3P8
Country
Canada
Facility Name
Toronto Digestive Disease Associates Inc. (TDDA)
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Hôpital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G2B 5S1
Country
Canada
Facility Name
GASTROMED s.c.
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny Oddz. Gastroenterologii
City
Czestochowa
ZIP/Postal Code
42-200
Country
Poland
Facility Name
SPZOZ Uniwersytecki Szpital Kliniczny
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
SPZOZ Uniwersytecki Szpital Kliniczny
City
Lodz
ZIP/Postal Code
90-549
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
SP Szpital Kliniczny
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Szpital Kolejowy
City
Pruszków
ZIP/Postal Code
05-800
Country
Poland
Facility Name
MEDICOR - Centrum Medyczne
City
Rzeszow
ZIP/Postal Code
35-068
Country
Poland
Facility Name
Endoskopia SP. Z o.o.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Gabinet Lekarski LECHMED
City
Warszawa
ZIP/Postal Code
02-511
Country
Poland

12. IPD Sharing Statement

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Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis

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