ProctitisPhase 2NCT01966783
Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis
A Phase 2 study testing Budesonide 2 mg suppository, Budesonide 4 mg suppository and Mesalazine 1 g suppository in people with Proctitis, run by Dr. Falk Pharma GmbH at 2 sites in Germany.
Trial summary
The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Proctitis
- What is being tested?
- Budesonide 2 mg suppository, Budesonide 4 mg suppository and Mesalazine 1 g suppository
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2013to Aug 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Active ulcerative proctitis
- Diagnosis confirmed by endoscopy
- Established disease or new diagnosis
Who cannot join
- Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular assoc. colitis, microscopic colitis
- Presence of proctitis of a different origin
- Prior bowel resection
- Presence of symptomatic organic disease of the gastrointestinal tract
- Asthma, tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection if careful medical monitoring is not ensured
- Local intestinal infection
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- Abnormal hepatic or renal function
- Oral/rectal/intravenous corticosteroids therapy
- Existing or intended pregnancy or breast-feeding
- Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité-Campus Benjamin Franklin Universitätsmedizin Berlin
Berlin, 12203
Evang. Krankenhaus Kalk, Medical Department
Cologne, 51103
About this study
Official title: Randomized, Double-blind, Multicentre Study to Compare the Efficacy and Safety of Budesonide Versus Mesalazine Suppository Versus a Combination Therapy of Budesonide/Mesalazine Suppositories in Patients With Acute Ulcerative Proctitis
The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.
- Conditions
- Proctitis
- Being tested
- Budesonide 2 mg suppository, Budesonide 4 mg suppository, Mesalazine 1 g suppository, Budesonide 2 mg suppository/Mesalazine 1 g suppository
- Medical subject headings
- Proctitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide 2 mg suppositoryDrug
per day
Budesonide 4 mg suppositoryDrug
per day
Mesalazine 1 g suppositoryDrug
per day
Budesonide 2 mg suppository/Mesalazine 1 g suppositoryDrug
per day
| Study group | Role | What they receive |
|---|---|---|
| Budesonide dosage 1 | Experimental | Budesonide 2 mg suppository Receives: Drug: Budesonide 2 mg suppository |
| Budesonide dosage 2 | Experimental | Budesonide 4 mg suppository Receives: Drug: Budesonide 4 mg suppository |
| Mesalazine | Active comparator | Mesalazine 1g suppository Receives: Drug: Mesalazine 1 g suppository |
| Combination | Experimental | Budesonide 2 mg suppository/Mesalazine 1 g suppository Receives: Drug: Budesonide 2 mg suppository/Mesalazine 1 g suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of clinical symptoms
Symptoms as reported in the diary
Measured: 8 weeks
Secondary outcomes (4)
Rate of clinical and endoscopic remission
Symptoms as reported in the diary, ulcerative colitis-disease activity index
Measured: 8 weeks
Rate of improvement
Symptoms as reported in the diary, ulcerative colitis-disease activity index
Measured: 8 weeks
Rate of patients with clinical remission
Symptoms as reported in the diary, ulcerative colitis-disease activity index
Measured: 8 weeks
Rate of patients with endoscopic remission
Ulcerative colitis-disease activity index
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 posted22 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProctitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Kruis, Professor, Principal investigator, Evang. Krankenhaus Kalk, Medical DepartmentBritta Siegmund, Professor, Principal investigator, Charité-Campus Benjamin Franklin Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966783
- Sponsor's protocol ID
- BUS-2/UCA
- Other IDs
- 2012-003362-41
- Status last verified
- May 2019
- First submitted
- 9 Oct 2013
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kruis W, Neshta V, Pesegova M, Alekseeva O, Andreev P, Datsenko O, Levchenko O, Abdulkhakov S, Lozynskyy Y, Mostovoy Y, Soloviev K, Dorofeyev AE, Vieth M, Stiess M, Greinwald R, Mohrbacher R, Siegmund B. Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis. Clin Gastroenterol Hepatol. 2019 Jan;17(1):98-106.e4. doi: 10.1016/j.cgh.2018.04.027. Epub 2018 Apr 24.
PubMed 29702300
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Multicentre Study to Compare the Efficacy and Safety of Budesonide Versus Mesalazine Suppository Versus a Combination Therapy of Budesonide/Mesalazine Suppositories in Patients With Acute Ulcerative Proctitis
- ClinicalTrials.gov ID
- NCT01966783
- Acronym / sponsor ID
- BUS-2/UCA
- Conditions
- Proctitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Not posted in the source record
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 investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Budesonide dosage 1 | Experimental | Drug: Budesonide 2 mg suppositoryBudesonide 2 mg suppository |
| Budesonide dosage 2 | Experimental | Drug: Budesonide 4 mg suppositoryBudesonide 4 mg suppository |
| Mesalazine | Active comparator | Drug: Mesalazine 1 g suppositoryMesalazine 1g suppository |
| Combination | Experimental | Drug: Budesonide 2 mg suppository/Mesalazine 1 g suppositoryBudesonide 2 mg suppository/Mesalazine 1 g suppository |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active ulcerative proctitis
- Diagnosis confirmed by endoscopy
- Established disease or new diagnosis
Key exclusion criteria (10 listed)
- Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular assoc. colitis, microscopic colitis
- Presence of proctitis of a different origin
- Prior bowel resection
- Presence of symptomatic organic disease of the gastrointestinal tract
- Asthma, tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection if careful medical monitoring is not ensured
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 |
|---|---|---|
| Budesonide 2 mg suppositoryper day | Drug | Budesonide dosage 1 |
| Budesonide 4 mg suppositoryper day | Drug | Budesonide dosage 2 |
| Mesalazine 1 g suppositoryper day | Drug | Mesalazine |
| Budesonide 2 mg suppository/Mesalazine 1 g suppositoryper day | Drug | Combination |
Primary outcome
Resolution of clinical symptoms
Time frame: 8 weeks
Symptoms as reported in the diary
4 secondary outcomes
Rate of clinical and endoscopic remission
Time frame: 8 weeks
Rate of improvement
Time frame: 8 weeks
Rate of patients with clinical remission
Time frame: 8 weeks
Rate of patients with endoscopic remission
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Results publication: PubMed 29702300Kruis W, Neshta V, Pesegova M, Alekseeva O, Andreev P, Datsenko O, Levchenko O, Abdulkhakov S, Lozynskyy Y, Mostovoy Y, Soloviev K, Dorofeyev AE, Vieth M, Stiess M, Greinwald R, Mohrbacher R, Siegmund B. Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis. Clin Gastroenterol Hepatol. 2019 Jan;17(1):98-106.e4. doi: 10.1016/j.cgh.2018.04.027. Epub 2018 Apr 24.
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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.
Wolfgang Kruis, Professor principal investigator
Evang. Krankenhaus Kalk, Medical Department
Britta Siegmund, Professor principal investigator
Charité-Campus Benjamin Franklin Universitätsmedizin Berlin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Budesonide 2 mg suppository, Budesonide 4 mg suppository and Mesalazine 1 g suppository in people with Proctitis, run by Dr. Falk Pharma GmbH at 2 sites in Germany.
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 3 inclusion and 10 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resolution of clinical symptoms (time frame: 8 weeks). 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 NCT01966783, which also lists 1 linked publication.
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 7 May 2019.