ProctitisPhase 3NCT01008423
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
A Phase 3 study testing Budesonide in people with Proctitis and Proctosigmoiditis, run by Bausch Health Americas, Inc. at 62 sites in United States.
Trial summary
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proctitis, Proctosigmoiditis
- What is being tested?
- Budesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 281 participants
- Where
- 62 sitesUnited States
- Study dates
- 20 Nov 2009to 18 Mar 2013
- 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
- Voluntarily sign written informed consent.
- Male or non-pregnant and non-lactating females.
- Confirmed diagnosis (by endoscopy procedure) of active, mild to moderate UP or UPS, with disease extending at least 5 centimeters (cm) but no further than 40 cm from the anal verge.
- Must possess a baseline MMDAI score between 5 and 10.
Who cannot join
- History or current diagnosis of Crohn's disease and indeterminate colitis.
- Prior gastrointestinal surgery except appendectomy and hernia.
- Concomitant active gastrointestinal disease or distortion of intestinal anatomy.
- History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease.
- Uncontrolled, previously diagnosed type 1 or 2 diabetes mellitus.
- Uncontrolled abnormal thyroid function.
Show all 22Show fewer
- Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease.
- Hemoglobin levels less than (<) 7.5 grams /deciliter (g/dL).
- History of sclerosing cholangitis, cirrhosis, or hepatic impairment.
- Renal disease manifested by greater than (>) 2.0 milligrams/deciliter (mg/dL) serum creatinine.
- History of avascular hip necrosis, active tuberculosis, ocular herpes simplex or ocular varicella zoster, malignant disease, and HIV or hepatitis B or C.
- Adrenal insufficiency.
- Active systemic or cutaneous infection or toxic megacolon, fistula, perforation or abscess.
- History of uncontrolled psychiatric disorders or seizure disorders.
- History of asthma requiring ongoing use of inhaled steroids.
- Recent history of drug or alcohol abuse.
- Positive stool test for bacterial pathogens, Clostridium difficile toxin, or ovum and parasites.
- Vaccination within 28 days prior to randomization.
- Allergies to budesonide or to any other items used in its preparation.
- Participation in another clinical trial in the past 30 days.
- Pregnant or at risk of pregnancy.
- Taking a prohibited medication. Some medications to treat UP/UPS are prohibited during participation in the study, including laxatives and anti-diarrhea medications; however, oral 5-ASA agents at doses up to 4.8 g/day and daily fiber supplements are allowed. Other medications (e.g., antibiotics, anti-seizure and anti-coagulant medicines) are also prohibited.
Trial locations and contacts
62 sites in 1 country.
62 sites in 1 country
United States62 sites
Study site
Altamonte Springs, Florida
Study site
Annapolis, Maryland
Study site
Asheville, North Carolina
Study site
Beachwood, Ohio
Study site
Bristol, Connecticut
Study site
Cape Coral, Florida
Study site
Chesapeake, Virginia
Study site
Chesterfield, Michigan
Study site
Chula Vista, California
Study site
Davenport, Iowa
Study site
Dothan, Alabama
Study site
Egg Harbor, New Jersey
Study site
Fayetteville, North Carolina
Study site
Garden Grove, California
Study site
Germantown, Tennessee
Study site
Great Neck, New York
Study site
Greensboro, North Carolina
Study site
Hagerstown, Maryland
Study site
Hamden, Connecticut
Study site
Hialeah, Florida
Study site
Houston, Texas
Study site
Jacksonville, North Carolina
Study site
La Porte, Texas
Study site
Lafayette, Colorado
Study site
Little Rock, Arkansas
Study site
Lynchburg, Virginia
Study site
Macon, Georgia
Study site
Marietta, Georgia
Study site
Marlton, New Jersey
Study site
Mesa, Arizona
Study site
Metairie, Louisiana
Study site
Mineola, New York
Study site
Mission Hills, California
Study site
Moline, Illinois
Study site
Monroe, Wisconsin
Study site
Monterey, California
Study site
New Bern, North Carolina
Study site
New York, New York
Study site
North Massapequa, New York
Study site
North Miami Beach, Florida
Study site
Ogden, Utah
Study site
Pasadena, Texas
Study site
Plano, Texas
Study site
Portland, Oregon
Study site
Prince Frederick, Maryland
Study site
Raleigh, North Carolina
Study site
Rochester, Michigan
Study site
Rocky Mount, North Carolina
Study site
Roseville, California
Study site
San Antonio, Texas
Study site
San Francisco, California
Study site
Silver Springs, Maryland
Study site
St Louis, Missouri
Study site
Stony Brook, New York
Study site
Suwanee, Georgia
Study site
Topeka, Kansas
Study site
Tucson, Arizona
Study site
Tulsa, Oklahoma
Study site
Tupelo, Mississippi
Study site
West Valley City, Utah
Study site
Wilmington, North Carolina
Study site
Winter Park, Florida
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Budesonide Foam (2 mg/25 mL BID for 2 Weeks, Followed by 2 mg/25 mL QD for 4 Weeks) Versus Placebo in Subjects With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible participants will be allowed to maintain previously established oral 5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day).
- Conditions
- Proctitis, Proctosigmoiditis
- Being tested
- Budesonide, Placebo
- Keywords
- Proctitis, Proctosigmoiditis, Ulcerative, Salix, Budesonide foam, Budesonide, Rectal, Gastrointestinal, Colitis, UC, UP, UPS, Additional relevant MeSH terms:, Proctocolitis, Ulcer, Colitis, Ulcerative, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases, Rectal Diseases
- Medical subject headings
- Proctitis, Proctocolitis, Ulcer, Colitis, Colitis, Ulcerative, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Budesonide will be administered as per the dose and schedule specified in the respective arm.
PlaceboDrug
Placebo matching to budesonide will be administered as per the dose and schedule specified in the respective arm.
| Study group | Role | What they receive |
|---|---|---|
| Budesonide | Experimental | Participants who were diagnosed with active mild to moderate UP or UPS, will receive 2 milligrams (mg)/25 milliliter (mL) of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks. Receives: Drug: Budesonide |
| Placebo | Placebo comparator | Participants who were diagnosed with active mild to moderate UP or UPS will receive 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved Remission
Remission was a combined assessment of clinical and endoscopic variables, defined as an endoscopy score of less than or equal to (<=) 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI) at the end of 6 weeks of treatment. MMDAI was used to assess the overall disease activity for each participant. MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment (PGA) and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Stool frequency MMDAI subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Endoscopy MMDAI subscore ranged from 0-3, where 0 indicated normal or inactive disease and 3 indicated severe disease (spontaneous bleeding, ulceration).
Measured: Week 6
Secondary outcomes (9)
Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices:stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Missing data was imputed using LOCF method.
Measured: Week 6
Number of Scheduled Assessments With Rectal Bleeding Responder Classification
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Percentage of participants who were rectal bleeding responder at scheduled assessments were reported. Rectal bleeding responders were defined as those participants who achieved a rectal bleeding MMDAI subscale score of 0 during the treatment period. Missing data was imputed using LOCF method.
Measured: Weeks 1, 2, 4, and 6
Percentage of Participants Who Achieved an Endoscopy MMDAI Subscale Score of 0 or 1 at End of Week 6
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Endoscopy subscale ranged from 0-3, where 0 = normal or inactive disease, 1 = mild disease, 2 = moderate disease and 3 = severe disease (spontaneous bleeding, ulceration). Percentage of participants with normal or mild disease have been presented in this outcome measure. Missing data was imputed using LOCF method.
Measured: Week 6
Percentage of Participants Who Achieved a Score of 0 for Rectal Bleeding Subscale and a Combined Score of <=2 for Bowel Frequency (BF) and Physician's Global Assessment (PGA) in the MMDAI Subscales at End of Week 6
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal disease and 3 indicated severe disease. Missing data was imputed using LOCF method.
Measured: Week 6
Percentage of Participants Who Achieved an MMDAI Total Score of <= 3 With Greater Than or Equal to (>=2) Points of Improvement From Baseline at the End of Week 6
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.
Measured: Week 6
Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Endoscopy Subscale Score at End of Week 6
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Endoscopy subscore ranged from 0-3, where 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern), 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 = severe disease (spontaneous bleeding, ulceration). Missing data was imputed using LOCF method.
Measured: Week 6
Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score at End of Week 6
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, and 3 indicated blood alone passed. Missing data was imputed using LOCF method.
Measured: Week 6
Percentage of Participants Who Achieved >=3 Point Improvement From Baseline in the MMDAI Total Score Including Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score and MMDAI Endoscopy Subscale at End of Week 6
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.
Measured: Week 6
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study start20 Nov 2009
- Primary completion18 Mar 2013
- Study completion18 Mar 2013
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ProctitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Bausch Health Companies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008423
- Sponsor's protocol ID
- BUCF3002
- Status last verified
- Jul 2019
- First submitted
- 4 Nov 2009
- Last updated
- 14 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bosworth BP, Sandborn WJ, Rubin DT, Harper JR. Baseline Oral 5-ASA Use and Efficacy and Safety of Budesonide Foam in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis: Analysis of 2 Phase 3 Studies. Inflamm Bowel Dis. 2016 Aug;22(8):1881-6. doi: 10.1097/MIB.0000000000000860.
PubMed 27416045Sandborn WJ, Bosworth B, Zakko S, Gordon GL, Clemmons DR, Golden PL, Rolleri RL, Yu J, Barrett AC, Bortey E, Paterson C, Forbes WP. Budesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis. Gastroenterology. 2015 Apr;148(4):740-750.e2. doi: 10.1053/j.gastro.2015.01.037. Epub 2015 Jan 30.
PubMed 25644096
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Budesonide Foam (2 mg/25 mL BID for 2 Weeks, Followed by 2 mg/25 mL QD for 4 Weeks) Versus Placebo in Subjects With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
- ClinicalTrials.gov ID
- NCT01008423
- Acronym / sponsor ID
- BUCF3002
- Conditions
- Proctitis, Proctosigmoiditis
- Keywords
- Proctitis, Proctosigmoiditis, Ulcerative, Salix, Budesonide foam, Budesonide, Rectal, Gastrointestinal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2009 (actual)
- Primary completion
- 18 Mar 2013 (actual)
- Study completion
- 18 Mar 2013 (actual)
- First posted
- 5 Nov 2009 (estimated)
- Results
- Posted 14 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible participants will be allowed to maintain previously established oral 5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide | Experimental | Drug: BudesonideParticipants who were diagnosed with active mild to moderate UP or UPS, will receive 2 milligrams (mg)/25 milliliter (mL) of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants who were diagnosed with active mild to moderate UP or UPS will receive 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily sign written informed consent.
- Male or non-pregnant and non-lactating females.
- Confirmed diagnosis (by endoscopy procedure) of active, mild to moderate UP or UPS, with disease extending at least 5 centimeters (cm) but no further than 40 cm from the anal verge.
- Must possess a baseline MMDAI score between 5 and 10.
Key exclusion criteria (22 listed)
- History or current diagnosis of Crohn's disease and indeterminate colitis.
- Prior gastrointestinal surgery except appendectomy and hernia.
- Concomitant active gastrointestinal disease or distortion of intestinal anatomy.
- History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease.
- Uncontrolled, previously diagnosed type 1 or 2 diabetes mellitus.
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 |
|---|---|---|
| BudesonideBudesonide will be administered as per the dose and schedule specified in the respective arm. | Drug | Budesonide |
| PlaceboPlacebo matching to budesonide will be administered as per the dose and schedule specified in the respective arm. | Drug | Placebo |
Primary outcome
Percentage of Participants Who Achieved Remission
Time frame: Week 6
Remission was a combined assessment of clinical and endoscopic variables, defined as an endoscopy score of less than or equal to (<=) 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI) at the end of 6 weeks of treatment. MMDAI was used to assess the overall disease activity for each participant. MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment (PGA) and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Stool frequency MMDAI subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Endoscopy MMDAI subscore ranged from 0-3, where 0 indicated normal or inactive disease and 3 indicated severe disease (spontaneous bleeding, ulceration).
9 secondary outcomes
Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6
Time frame: Week 6
Number of Scheduled Assessments With Rectal Bleeding Responder Classification
Time frame: Weeks 1, 2, 4, and 6
Percentage of Participants Who Achieved an Endoscopy MMDAI Subscale Score of 0 or 1 at End of Week 6
Time frame: Week 6
Percentage of Participants Who Achieved a Score of 0 for Rectal Bleeding Subscale and a Combined Score of <=2 for Bowel Frequency (BF) and Physician's Global Assessment (PGA) in the MMDAI Subscales at End of Week 6
Time frame: Week 6
Percentage of Participants Who Achieved an MMDAI Total Score of <= 3 With Greater Than or Equal to (>=2) Points of Improvement From Baseline at the End of Week 6
Time frame: Week 6
Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Endoscopy Subscale Score at End of Week 6
Time frame: Week 6
Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score at End of Week 6
Time frame: Week 6
Percentage of Participants Who Achieved >=3 Point Improvement From Baseline in the MMDAI Total Score Including Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score and MMDAI Endoscopy Subscale at End of Week 6
Time frame: Week 6
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores
Time frame: Baseline, Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27416045Bosworth BP, Sandborn WJ, Rubin DT, Harper JR. Baseline Oral 5-ASA Use and Efficacy and Safety of Budesonide Foam in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis: Analysis of 2 Phase 3 Studies. Inflamm Bowel Dis. 2016 Aug;22(8):1881-6. doi: 10.1097/MIB.0000000000000860.
- Derived from this study: PubMed 25644096Sandborn WJ, Bosworth B, Zakko S, Gordon GL, Clemmons DR, Golden PL, Rolleri RL, Yu J, Barrett AC, Bortey E, Paterson C, Forbes WP. Budesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis. Gastroenterology. 2015 Apr;148(4):740-750.e2. doi: 10.1053/j.gastro.2015.01.037. Epub 2015 Jan 30.
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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.
Study Director
Bausch Health Companies
62 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 Proctitis and Proctosigmoiditis, run by Bausch Health Americas, Inc. at 62 sites in United States.
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 4 inclusion and 22 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 14 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 62 sites in United States. 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 14 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 Achieved Remission (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01008423, which also lists 2 linked publications.
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 14 Aug 2019.