Diarrhea- Irritable Bowel SyndromeNeu-P11NCT01558284
The Effect of Neu-P11 on Symptoms in Patients With D-IBS
An observational study of Diarrhea- Irritable Bowel Syndrome, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Placebo controlled double-blind study with 40 patients who have an diarrhea-predominant IBS, 20 get Neu-P11, 20 get a placebo. Neu-P11 is a, Melatonin receptor-, Serotonin 5-HT- 1A and 5-HT- 1D - agonist and a serotonin 5-HT- 2B - antagonist. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diarrhea- Irritable Bowel Syndrome
- What is being tested?
- Neu-P11
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Feb 2014
- Phase
- Observational
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diarrhea-praedominant Irritated Bowel Syndroms
Who may be able to join
- Subjects age 18-80 years old
- Male or female
- Women of childbearing potential must have a negative pregnancy test at the screening visit, on Day 1 of each treatment period, and use a reliable method of contraception during the entire study duration and for at least 3 months after study drug intake. Reliable methods of contraception are:
- oral contraception
- Double barrier type devices (e.g., male or female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.
- Intra-uterine devices in combination with a spermicide. Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception. Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile.
- Subject has IBS confirmed by the Rome III diagnostic criteria
Who cannot join
- Subject has current evidence of duodenal ulcer, gastric ulcer, diverticulitis, or infectious gastroenteritis.
- Subject has a history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, celiac disease), GI malignancy, GI obstruction, gastroparesis, carcinoid syndrome, pancreatitis, amyloidosis or ileus
- Subject is a candidate for GI surgery or has a history of GI surgery except appendectomy and cholecystectomy.
- Subject has psychiatric disorders which are not controlled (based on the investigator medical judgment); subject with psychosis are excluded regardless of current therapy.
- Subject has current or recent history (within 12 months of signing on informed consent) of drug or alcohol abuse.
- Subject is pregnant or lactating
Show all 10Show fewer
- Subject has history of human immunodeficiency virus (HIV) or hepatitis (B or C)
- Subject has any condition or circumstance that could cause noncompliance with treatments or visits
- Subject has active malignancy within the last 5 years.
- Subject taking antipsychotic drugs, antispasmodics, antidiarrheals (e.g. loperamide, lubiprostone and bismuth subsalicylate), narcotics, prokinetic drugs, drugs indicated for IBS (e.g Alosetron), or warfarin.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Grosshadern Medizinische Klinik 2
Munich, Bavaria, 81377
About this study
Official title: Clinical Study on the Effect of Neu-P11 on Symptoms in Patients With Diarrhea- Irritable Bowel Syndrome (D-IBS)
Placebo controlled double-blind study with 40 patients who have an diarrhea-predominant IBS, 20 get Neu-P11, 20 get a placebo. Neu-P11 is a, Melatonin receptor-, Serotonin 5-HT- 1A and 5-HT- 1D - agonist and a serotonin 5-HT- 2B - antagonist.
Read the detailed description
This study aims to test a possible beneficial effect of NEU-P11 in patients with IBS.
The effect on symptoms will be rated by symptom scores. The primary endpoint will be the symptomatic benefit reported by the patient answering the simple question: Did your symptoms improve compared to prior to the clinical trial.
Additional secondary endpoints will capture sleep quality, changes in stool texture and individual symptom scores employing standardized symptom scores.
The study design is a 4 week, randomised, placebo-controlled, double blind study where 40 patients receive either placebo (20) or NEU-P11 (20). In the mid of the four week time of the Study the dose can be doubled of the patient does not recognize any relief of the D-IBS.
- Conditions
- Diarrhea- Irritable Bowel Syndrome
- Being tested
- Neu-P11, Placebo
- Keywords
- Irritable bowel syndrome, Neu-P11, Melatonin, D-IBS
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neu-P11Drug
Also called there are no other names
Neu-P11 is a new Melatonin receptor-, Serotonin 5-HT- 1A and 5-HT- 1D - agonist and a serotonin 5-HT- 2B - antagonist
PlaceboDrug
Also called there are no other names
Placebo
What is being measured
The primary outcome is the main question the study is designed to answer.
The relief of symptoms of the D-IBS by the study medication.
Only one question at the end of each visit and of each telephone call
Measured: after each week for the time of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2014
- Study completionFeb 2014
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 Diarrhea- Irritable Bowel SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Storr, Ludwig-Maximilians - University of Munich
- Investigators
- Martin Storr, Prof Dr., Principal investigator, Medizinische Klinik 2 LMU Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558284
- Sponsor's protocol ID
- STO-010
- Other IDs
- 2011-002657-60
- Acronym
- Neu-P11
- Status last verified
- Feb 2014
- First submitted
- 8 Mar 2012
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Storr M. [Therapy of gastroesophageal reflux disease (GERD)]. Med Monatsschr Pharm. 2011 Dec;34(12):446-54; quiz 455-6. German.
PubMed 22233024
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effect of Neu-P11 on Symptoms in Patients With Diarrhea- Irritable Bowel Syndrome (D-IBS)
- ClinicalTrials.gov ID
- NCT01558284
- Acronym / sponsor ID
- Neu-P11 / STO-010
- Conditions
- Diarrhea- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, Neu-P11, Melatonin, D-IBS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Mar 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.
Placebo controlled double-blind study with 40 patients who have an diarrhea-predominant IBS, 20 get Neu-P11, 20 get a placebo. Neu-P11 is a, Melatonin receptor-, Serotonin 5-HT- 1A and 5-HT- 1D - agonist and a serotonin 5-HT- 2B - antagonist.
Detailed description
This study aims to test a possible beneficial effect of NEU-P11 in patients with IBS.
The effect on symptoms will be rated by symptom scores. The primary endpoint will be the symptomatic benefit reported by the patient answering the simple question: Did your symptoms improve compared to prior to the clinical trial.
Additional secondary endpoints will capture sleep quality, changes in stool texture and individual symptom scores employing standardized symptom scores.
The study design is a 4 week, randomised, placebo-controlled, double blind study where 40 patients receive either placebo (20) or NEU-P11 (20). In the mid of the four week time of the Study the dose can be doubled of the patient does not recognize any relief of the D-IBS.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diarrhea-praedominant Irritated Bowel Syndroms
Key inclusion criteria (7 listed)
- Subjects age 18-80 years old
- Male or female
- Women of childbearing potential must have a negative pregnancy test at the screening visit, on Day 1 of each treatment period, and use a reliable method of contraception during the entire study duration and for at least 3 months after study drug intake. Reliable methods of contraception are:
- Subject has IBS confirmed by the Rome III diagnostic criteria
Key exclusion criteria (10 listed)
- Subject has current evidence of duodenal ulcer, gastric ulcer, diverticulitis, or infectious gastroenteritis.
- Subject has a history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, celiac disease), GI malignancy, GI obstruction, gastroparesis, carcinoid syndrome, pancreatitis, amyloidosis or ileus
- Subject is a candidate for GI surgery or has a history of GI surgery except appendectomy and cholecystectomy.
- Subject has psychiatric disorders which are not controlled (based on the investigator medical judgment); subject with psychosis are excluded regardless of current therapy.
- Subject has current or recent history (within 12 months of signing on informed consent) of drug or alcohol abuse.
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 |
|---|---|---|
| Neu-P11Also: there are no other namesNeu-P11 is a new Melatonin receptor-, Serotonin 5-HT- 1A and 5-HT- 1D - agonist and a serotonin 5-HT- 2B - antagonist | Drug | – |
| PlaceboAlso: there are no other namesPlacebo | Drug | – |
Primary outcome
The relief of symptoms of the D-IBS by the study medication.
Time frame: after each week for the time of study
Only one question at the end of each visit and of each telephone call
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 5 Feb 2014.
- Background: PubMed 22233024Storr M. [Therapy of gastroesophageal reflux disease (GERD)]. Med Monatsschr Pharm. 2011 Dec;34(12):446-54; quiz 455-6. German.
- Sponsor of the TrialLink provided by the sponsor.
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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.
Martin Storr, Prof Dr. principal investigator
Medizinische Klinik 2 LMU Muenchen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea- Irritable Bowel Syndrome, run by Ludwig-Maximilians - University of Munich 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 7 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 5 Feb 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 relief of symptoms of the D-IBS by the study medication. (time frame: after each week for the time of study). 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 NCT01558284, 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 5 Feb 2014.