Colonic DiverticulosisPhase 2NCT01627262
Mesalamine for Uncomplicated Diverticular Disease: a Randomized, Double-blind, Placebo-controlled Study
A Phase 2 study testing Mesalamine in people with Colonic Diverticulosis, run by Dr. Falk Pharma GmbH at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether mesalamine is effective in the treatment of uncomplicated diverticular disease by reducing the pain. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Colonic Diverticulosis
- What is being tested?
- Mesalamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteGermany
- Study dates
- May 2002to Apr 2006
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diverticular disease with acute pain without serious complications
- Lower abdominal pain of moderate or severe intensity at least during the last 4 days before study inclusion
Who cannot join
- Chronic inflammatory bowel disease
- Fever or other signs of serious complications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomised, Placebo-controlled, Parallel-group, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Mesalazine Pellets vs. Placebo in Diverticular Disease
The purpose of this study is to determine whether mesalamine is effective in the treatment of uncomplicated diverticular disease by reducing the pain.
- Conditions
- Colonic Diverticulosis
- Being tested
- Mesalamine, Placebo
- Keywords
- diverticular disease, colonic diverticulosis, mesalamine, placebo, randomized
- Medical subject headings
- Diverticulosis, Colonic, Diverticular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesalamineDrug
Also called Salofalk granules
3x1000mg mesalamine granules per day
PlaceboDrug
Also called Placebo granules
3x1000mg placebo granules per day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Mesalamine | Experimental | Not described Receives: Drug: Mesalamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in intensity of lower abdominal pain during the first four weeks of treatment (SPID 0-28)
The change in intensity of lower abdominal pain during the first four weeks of treatment, defined as the cumulative difference of the daily pain intensity score from the first day of study medication intake (day 1) to week 4
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startMay 2002
- Primary completionAug 2004
- Study completionApr 2006
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 Colonic DiverticulosisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Kruis, MD, Principal investigator, Ev. Krankenhaus Kalk, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627262
- Sponsor's protocol ID
- SAG-20/DIV
- Status last verified
- Jan 2016
- First submitted
- 21 Jun 2012
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kruis W, Meier E, Schumacher M, Mickisch O, Greinwald R, Mueller R; German SAG-20 Study Group. Randomised clinical trial: mesalazine (Salofalk granules) for uncomplicated diverticular disease of the colon--a placebo-controlled study. Aliment Pharmacol Ther. 2013 Apr;37(7):680-90. doi: 10.1111/apt.12248. Epub 2013 Feb 17.
PubMed 23414061
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomised, Placebo-controlled, Parallel-group, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Mesalazine Pellets vs. Placebo in Diverticular Disease
- ClinicalTrials.gov ID
- NCT01627262
- Acronym / sponsor ID
- SAG-20/DIV
- Conditions
- Colonic Diverticulosis
- Keywords
- diverticular disease, colonic diverticulosis, mesalamine, placebo, randomized
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Aug 2004 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 25 Jun 2012 (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 determine whether mesalamine is effective in the treatment of uncomplicated diverticular disease by reducing the pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Mesalamine | Experimental | Drug: Mesalamine |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of diverticular disease with acute pain without serious complications
- Lower abdominal pain of moderate or severe intensity at least during the last 4 days before study inclusion
Key exclusion criteria (2 listed)
- Chronic inflammatory bowel disease
- Fever or other signs of serious complications.
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 |
|---|---|---|
| MesalamineAlso: Salofalk granules3x1000mg mesalamine granules per day | Drug | Mesalamine |
| PlaceboAlso: Placebo granules3x1000mg placebo granules per day | Drug | Placebo |
Primary outcome
The change in intensity of lower abdominal pain during the first four weeks of treatment (SPID 0-28)
Time frame: 4 weeks
The change in intensity of lower abdominal pain during the first four weeks of treatment, defined as the cumulative difference of the daily pain intensity score from the first day of study medication intake (day 1) to week 4
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 21 Jan 2016.
- Results publication: PubMed 23414061Kruis W, Meier E, Schumacher M, Mickisch O, Greinwald R, Mueller R; German SAG-20 Study Group. Randomised clinical trial: mesalazine (Salofalk granules) for uncomplicated diverticular disease of the colon--a placebo-controlled study. Aliment Pharmacol Ther. 2013 Apr;37(7):680-90. doi: 10.1111/apt.12248. Epub 2013 Feb 17.
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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, MD principal investigator
Ev. Krankenhaus Kalk, University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesalamine in people with Colonic Diverticulosis, run by Dr. Falk Pharma GmbH at 1 site 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 2 inclusion and 2 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 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 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?
The change in intensity of lower abdominal pain during the first four weeks of treatment (SPID 0-28) (time frame: 4 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 NCT01627262, 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 21 Jan 2016.