Colitis, UlcerativePhase 3NCT01100112
(CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets
A Phase 3 study testing Budesonide in people with Colitis, Ulcerative, run by Bausch Health Americas, Inc. at 15 sites in India.
Trial summary
Open-label, 8 week study, to assess the efficacy and safety of oral Budesonide-MMX 9 mg Extended-release Tablets in patients with mild to moderate, active ulcerative colitis who are not in remission based on the Ulcerative Colitis Disease Activity Index in study CB-01-02/01 (parent study [NCT00679432]). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Budesonide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 15 sitesIndia
- Study dates
- Feb 2010to Aug 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients 18 to 74 years of age, who are able to understand and voluntarily provide written informed consent
- Completed all Final Visit assessments for study CB-01-02/01 (NCT00679432) and are not in clinical remission
- Diagnosis of ulcerative colitis of mild to moderate severity with an Ulcerative Colitis Disease Activity Index (UCDAI) <or= 10 according to Sutherland
- Females of child-bearing potential must have had a serum pregnancy test performed at the Final Visit of the parent study, and must use an acceptable contraceptive method throughout the treatment period. Female subjects must also not be actively breast-feeding through the entire study period.
- Ability to comprehend the full nature and purpose of the study, including possible risks and side effects
- Ability to co-operate with the investigator and to comply with the requirements of the entire study
Who cannot join
- Did not complete study CB-01-02/01
- Achieved clinical remission in study CB-01-02/01
- Patients with severe ulcerative colitis (UCDAI >10)
- Patients with infectious colitis
- Evidence or history of toxic megacolon
- Severe anemia, leucopenia, or granulocytopenia
Show all 19Show fewer
- Use of immunosuppressive agents in the last 8 weeks before the study
- use of anti-tumor necrosis factor alpha agents in the last three months
- Concomitant use of any rectal preparation for the treatment of ulcerative colitis
- Concomitant use of antibiotics
- Concurrent use of cytochrome P-450 3A4 (CYP3A4) inducers and CYP3A4 inhibitors.
- Patients with verified, presumed of expected pregnancy or ongoing lactation
- Patients with liver cirrhosis, or evident hepatic or renal disease or insufficiency and/or severe impairment of the bio-humoral parameters (i.e., 2x upper limit of normal for alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, or creatinine)
- Patients with severe disease(s) in other organs of systems
- Patients with local of systemic complications of other pathological states requiring a therapy with corticosteroids and/or immunosuppressive agents
- Patients diagnosed with Type 1 diabetes
- Patients diagnosed with or with a family history of glaucoma
- Patients with known hepatitis B, hepatitis C, or with human immunodeficiency virus (HIV), according to the local privacy policy
- Any other medical condition that in the principal investigator's opinion would make the administration of the study drug or study procedures hazardous to the subject or obscure the interpretation of adverse events
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
India15 sites
Santarus Clinical Investigational Site 9001
Andhra Pradesh
Santarus Clinical Investigational Site 9009
Andhra Pradesh
Santarus Clinical Investigational Site 9012
Andhra Pradesh
Santarus Clinical Investigational Site 9016
Andhra Pradesh
Santarus Clinical Investigational Site 9006
Assam
Santarus Clinical Investigational Site 9007
Gujarat
Santarus Clinical Investigational Site 9004
Karnataka
Santarus Clinical Investigational Site 9015
Karnataka
Santarus Clinical Investigational Site 9003
Kerala
Santarus Clinical Investigational Site 9002
Maharashtra
Santarus Clinical Investigational Site 9008
Maharashtra
Santarus Clinical Investigational Site 9013
Maharashtra
Santarus Clinical Investigational Site 9018
Rajasthan
Santarus Clinical Investigational Site 9005
Tamil Nadu
Santarus Clinical Investigational Site 9014
Uttar Pradesh
About this study
Official title: Multicenter, Open-Label Efficacy and Safety Study of Oral Budesonide-MMX 9mg Extended Release Tablets in Patients With Mild to Moderate, Active Ulcerative Colitis
Open-label, 8 week study, to assess the efficacy and safety of oral Budesonide-MMX 9 mg Extended-release Tablets in patients with mild to moderate, active ulcerative colitis who are not in remission based on the Ulcerative Colitis Disease Activity Index in study CB-01-02/01 (parent study [NCT00679432]).
Read the detailed description
Patients who complete the parent study and who do not achieve clinical remission will be eligible to receive 8 weeks of open-label treatment with Budesonide-MMX 9mg if they satisfy the entry criteria for this study.
- Conditions
- Colitis, Ulcerative
- Being tested
- Budesonide
- Keywords
- ulcerative colitis, Budesonide
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Budesonide | Experimental | Budesonide-MMX 9 mg tablet Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Patients Achieving Clinical Remission
The primary efficacy endpoint is clinical remission at 8 weeks, defined as a Ulcerative Colitis Disease Activity Index score of < or = 1 with a score of 0 for both rectal bleeding and stool frequency, and > or = 1 point reduction from baseline in endoscopy score, without any sign of mucosal friability (a score of 0 for mucosal appearance).
The UCDAI has 4 components. Each component is scored on scale of 0 to 3 (total maximum [worst] score = 12). Definitions of component scores are as follows: stool frequency: 0 = normal frequency, 1 = 1 - 2 stools per day greater than normal frequency, 2 = 3 - 4 stools per day greater than normal frequency, and 3 = > 4 stools per day greater than normal frequency; rectal bleeding: 0 = none, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood; physician's rating of disease activity: 0 = normal, 1 = mild, 2 = moderate, 3 = severe; mucosal appearance: 0 = normal, 1 = mild friability, 2 = moderate friability, 3 = exudation, spontaneous bleeding.
Measured: At the end of the 8 week treatment period
Secondary outcomes (3)
The Secondary Efficacy Endpoint is Clinical Improvement
The secondary efficacy endpoint is clinical improvement, defined as a drop in the Ulcerative Colitis Disease Activity Index score of > or = 3 points from baseline.
Measured: After 8 weeks treatment period
Safety Evaluations: the Numbers of Patients Who Experience Serious Adverse Events (SAEs) or Other Nonserious Adverse Events (AEs) During the Course of the Study.
Safety will be assessed by evaluating SAEs and AEs. The outcome measure data are the numbers of patients who experienced SAEs or other nonserious AEs.
Measured: Throughout the 8 week treatment period
Endoscopic Improvement
Greater or equal to a 1 point improvement in the mucosal appearance subscore of the ulcerative colitis disease activity index (UCDAI), from baseline to week 8.
The UCDAI mucosal appearance subscore is graded as follows: 0 = normal, 1 = mild friability, 2 = moderate friability, 3 = exudation, spontaneous bleeding.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionAug 2010
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 Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cosmo Technologies Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100112
- Sponsor's protocol ID
- CB-01-02/06
- Status last verified
- Nov 2019
- First submitted
- 6 Apr 2010
- Last updated
- 29 Nov 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 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-Label Efficacy and Safety Study of Oral Budesonide-MMX 9mg Extended Release Tablets in Patients With Mild to Moderate, Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01100112
- Acronym / sponsor ID
- CB-01-02/06
- Conditions
- Colitis, Ulcerative
- Keywords
- ulcerative colitis, Budesonide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cosmo Technologies Ltd
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 8 Apr 2010 (estimated)
- Results
- Posted 5 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, 8 week study, to assess the efficacy and safety of oral Budesonide-MMX 9 mg Extended-release Tablets in patients with mild to moderate, active ulcerative colitis who are not in remission based on the Ulcerative Colitis Disease Activity Index in study CB-01-02/01 (parent study [NCT00679432]).
Detailed description
Patients who complete the parent study and who do not achieve clinical remission will be eligible to receive 8 weeks of open-label treatment with Budesonide-MMX 9mg if they satisfy the entry criteria for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Budesonide | Experimental | Drug: BudesonideBudesonide-MMX 9 mg tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients 18 to 74 years of age, who are able to understand and voluntarily provide written informed consent
- Completed all Final Visit assessments for study CB-01-02/01 (NCT00679432) and are not in clinical remission
- Diagnosis of ulcerative colitis of mild to moderate severity with an Ulcerative Colitis Disease Activity Index (UCDAI) <or= 10 according to Sutherland
- Females of child-bearing potential must have had a serum pregnancy test performed at the Final Visit of the parent study, and must use an acceptable contraceptive method throughout the treatment period. Female subjects must also not be actively breast-feeding through the entire study period.
- Ability to comprehend the full nature and purpose of the study, including possible risks and side effects
Key exclusion criteria (19 listed)
- Did not complete study CB-01-02/01
- Achieved clinical remission in study CB-01-02/01
- Patients with severe ulcerative colitis (UCDAI >10)
- Patients with infectious colitis
- Evidence or history of toxic megacolon
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 |
|---|---|---|
| BudesonideOne Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks. | Drug | Budesonide |
Primary outcome
The Percentage of Patients Achieving Clinical Remission
Time frame: At the end of the 8 week treatment period
The primary efficacy endpoint is clinical remission at 8 weeks, defined as a Ulcerative Colitis Disease Activity Index score of < or = 1 with a score of 0 for both rectal bleeding and stool frequency, and > or = 1 point reduction from baseline in endoscopy score, without any sign of mucosal friability (a score of 0 for mucosal appearance). The UCDAI has 4 components. Each component is scored on scale of 0 to 3 (total maximum [worst] score = 12). Definitions of component scores are as follows: stool frequency: 0 = normal frequency, 1 = 1 - 2 stools per day greater than normal frequency, 2 = 3 - 4 stools per day greater than normal frequency, and 3 = > 4 stools per day greater than normal frequency; rectal bleeding: 0 = none, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood; physician's rating of disease activity: 0 = normal, 1 = mild, 2 = moderate, 3 = severe; mucosal appearance: 0 = normal, 1 = mild friability, 2 = moderate friability, 3 = exudation, spontaneous bleeding.
3 secondary outcomes
The Secondary Efficacy Endpoint is Clinical Improvement
Time frame: After 8 weeks treatment period
Safety Evaluations: the Numbers of Patients Who Experience Serious Adverse Events (SAEs) or Other Nonserious Adverse Events (AEs) During the Course of the Study.
Time frame: Throughout the 8 week treatment period
Endoscopic Improvement
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide in people with Colitis, Ulcerative, run by Bausch Health Americas, Inc. at 15 sites in India.
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 6 inclusion and 19 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: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in India. 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. 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 5 Jun 2014). 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?
The Percentage of Patients Achieving Clinical Remission (time frame: At the end of the 8 week treatment period). 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 29 Nov 2019.