NCT01558284

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 8, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 5, 2014

Status Verified

February 1, 2014

Enrollment Period

1.9 years

First QC Date

March 8, 2012

Last Update Submit

February 4, 2014

Conditions

Diarrhea- Irritable Bowel Syndrome

Keywords

Irritable bowel syndromeNeu-P11MelatoninD-IBS

Outcome Measures

Primary Outcomes (1)

  • 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

    after each week for the time of study

Interventions

Neu-P11DRUG

Neu-P11 is a new Melatonin receptor-, Serotonin 5-HT- 1A and 5-HT- 1D - agonist and a serotonin 5-HT- 2B - antagonist

Also known as: there are no other names
PlaceboDRUG

Placebo

Also known as: there are no other names

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diarrhea-praedominant Irritated Bowel Syndroms

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Grosshadern Medizinische Klinik 2

Munich, Bavaria, 81377, Germany

Location

Related Publications (1)

  • Storr M. [Therapy of gastroesophageal reflux disease (GERD)]. Med Monatsschr Pharm. 2011 Dec;34(12):446-54; quiz 455-6. German.

    PMID: 22233024BACKGROUND

Related Links

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

N-(2-(5-methoxy-indol-3-yl)-ethyl)-4-oxo-4H-pyran-2-carboxamide

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Martin Storr, Prof Dr.

    Medizinische Klinik 2 LMU Muenchen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr.

Study Record Dates

First Submitted

March 8, 2012

First Posted

March 20, 2012

Study Start

February 1, 2012

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

February 5, 2014

Record last verified: 2014-02

Locations

DE(1)