Proctitis, UlcerativePhase 3NCT01016262
Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
A Phase 3 study testing MAX-002 and Canasa® in people with Proctitis, Ulcerative, run by Forest Laboratories at 40 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proctitis, Ulcerative
- What is being tested?
- MAX-002 and Canasa®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 40 sitesin 3 countries
- Study dates
- 30 Nov 2009to 30 Sep 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
40 sites in 3 countries.
40 sites in 3 countries
United States22 sites
Birmingham Gastroenterology Associates P.C.
Birmingham, Alabama, 35209
Clinical Research of South Florida
Boynton Beach, Florida, 33426
Synergy First Medical
Brooklyn, New York, 11230
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305
Advanced Pain Care Clinic
Evansville, Indiana, 47714
Memphis Gastroenterology Group
Germantown, Tennessee, 38138
Center for Gastrointestinal Disorders
Hollywood, Florida, 33021
Gastrointestinal Associates
Jackson, Mississippi, 39202
South Texas Research Alliance
Laredo, Texas, 78041
South Jersey Gastroenterology
Marlton, New Jersey, 08053
Center for Digestive & Liver Diseases Inc.
Mexico, Missouri, 65265
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215
Gastroenterology Group of Naples
Naples, Florida, 34102
The First Clinic
Nashville, Tennessee, 37203
Research Associates of New York (RANY)
New York, New York, 10075
Digestive Research Associates
Newnan, Georgia, 30263
Rocky Mountain Gastroenterology Associates
Thornton, Colorado, 80229
Litchfield County Gastroenterology and Associates
Torrington, Connecticut, 06790
Desert Sun Gastroenterology
Tucson, Arizona, 85710
Shafran Gastroenterology Center
Winter Park, Florida, 32789
Poland10 sites
GASTROMED s.c.
Bialystok, 15-351
Wojewódzki Szpital Specjalistyczny Oddz. Gastroenterologii
Częstochowa, 42-200
SPZOZ Uniwersytecki Szpital Kliniczny
Lodz, 90-153
SPZOZ Uniwersytecki Szpital Kliniczny
Lodz, 90-549
Wojewodzki Szpital Specjalistyczny
Lublin, 20-718
SP Szpital Kliniczny
Lublin, 20-954
Szpital Kolejowy
Pruszków, 05-800
MEDICOR - Centrum Medyczne
Rzeszów, 35-068
Endoskopia SP. Z o.o.
Sopot, 81-756
Gabinet Lekarski LECHMED
Warsaw, 02-511
Canada8 sites
Gastroenterology & Hepatology Clinic
Abbotsford British Columbia, British Columbia, V2S 3N5
Surrey GI Clinic Research
Guelph, Ontario, N1H 3R3
St-Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Alpha Recherche Clinique
Québec, Quebec, G2B 5S1
DHC Research
Richmond Hill, Ontario, L4B 3P8
Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1N9
Toronto Digestive Disease Associates Inc. (TDDA)
Vaughan, Ontario, L4L 4Y7
About this study
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
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).
Read the 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.
- Conditions
- Proctitis, Ulcerative
- Being tested
- MAX-002, Placebo, Canasa®
- Keywords
- Ulcerative proctitis, Proctocolitis, Inflammatory Bowel Disease, Gastrointestinal Diseases, Colonic Diseases, Mesalamine, 5-ASA
- Medical subject headings
- Proctitis, Ulcer, Proctocolitis, Inflammatory Bowel Diseases, Gastrointestinal Diseases, Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAX-002Drug
Also called Mesalamine
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.
PlaceboDrug
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.
Canasa®Drug
Also called Mesalamine
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.
| Study group | Role | What they receive |
|---|---|---|
| MAX-002 | Experimental | Not described Receives: Drug: MAX-002 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Canasa® | Active comparator | Not described Receives: Drug: Canasa® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 6
Secondary outcomes (4)
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).
Measured: Week 3
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.
Measured: Day 1 up to Week 6
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.
Measured: Baseline, Week 6
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.
Measured: Day 1 up to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study start30 Nov 2009
- Primary completion31 Jul 2011
- Study completion30 Sep 2011
Why it stopped: The decision was taken solely for business/administrative reasons, no safety considerations entered into this. Ongoing randomized patients to complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Proctitis, UlcerativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aptalis Medical Information, Study director, Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016262
- Sponsor's protocol ID
- CD-ME-CAPSITUP508-01
- Status last verified
- Aug 2019
- First submitted
- 17 Nov 2009
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01016262
- Acronym / sponsor ID
- CD-ME-CAPSITUP508-01
- Conditions
- Proctitis, Ulcerative
- Keywords
- Ulcerative proctitis, Proctocolitis, Inflammatory Bowel Disease, Gastrointestinal Diseases, Colonic Diseases, Mesalamine, 5-ASA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision was taken solely for business/administrative reasons, no safety considerations entered into this. Ongoing randomized patients to complete.
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2009 (actual)
- Primary completion
- 31 Jul 2011 (actual)
- Study completion
- 30 Sep 2011 (actual)
- First posted
- 19 Nov 2009 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MAX-002 | Experimental | Drug: MAX-002 |
| Placebo | Placebo comparator | Drug: Placebo |
| Canasa® | Active comparator | Drug: Canasa® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAX-002Also: MesalamineMAX-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. | Drug | MAX-002 |
| PlaceboMatching 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. | Drug | Placebo |
| Canasa®Also: MesalamineCanasa® 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. | Drug | Canasa® |
Primary outcome
Percentage of Participants Who Were Responders at Week 6
Time frame: 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).
4 secondary outcomes
Percentage of Participants Who Were Responders at Week 3
Time frame: Week 3
Time to Relief of Rectal Bleeding
Time frame: Day 1 up to Week 6
Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6
Time frame: Baseline, Week 6
Time to Relief of Tenesmus
Time frame: Day 1 up to Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aptalis Medical Information study director
Forest Laboratories
40 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MAX-002 and Canasa® in people with Proctitis, Ulcerative, run by Forest Laboratories at 40 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Poland, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Were Responders at Week 6 (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.