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The Effect of Neu-P11 on Symptoms in Patients With D-IBS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martin Storr, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01558284
First received: March 8, 2012
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Diarrhea- Irritable Bowel Syndrome
Drug: Neu-P11
Drug: Placebo

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical Study on the Effect of Neu-P11 on Symptoms in Patients With Diarrhea- Irritable Bowel Syndrome (D-IBS)

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • The relief of symptoms of the D-IBS by the study medication. [ Time Frame: after each week for the time of study ] [ Designated as safety issue: Yes ]
    Only one question at the end of each visit and of each telephone call


Enrollment: 40
Study Start Date: February 2012
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Neu-P11
    Neu-P11 is a new Melatonin receptor-, Serotonin 5-HT- 1A and 5-HT- 1D - agonist and a serotonin 5-HT- 2B - antagonist
    Other Name: there are no other names
    Drug: Placebo
    Placebo
    Other Name: there are no other names
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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with diarrhea-praedominant Irritated Bowel Syndroms

Criteria

Inclusion Criteria:

  1. Subjects age 18-80 years old
  2. 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.
  3. Subject has IBS confirmed by the Rome III diagnostic criteria

Exclusion Criteria:

  1. Subject has current evidence of duodenal ulcer, gastric ulcer, diverticulitis, or infectious gastroenteritis.
  2. 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
  3. Subject is a candidate for GI surgery or has a history of GI surgery except appendectomy and cholecystectomy.
  4. Subject has psychiatric disorders which are not controlled (based on the investigator medical judgment); subject with psychosis are excluded regardless of current therapy.
  5. Subject has current or recent history (within 12 months of signing on informed consent) of drug or alcohol abuse.
  6. Subject is pregnant or lactating
  7. Subject has history of human immunodeficiency virus (HIV) or hepatitis (B or C)
  8. Subject has any condition or circumstance that could cause noncompliance with treatments or visits
  9. Subject has active malignancy within the last 5 years.
  10. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558284

Locations
Germany
Klinikum Grosshadern Medizinische Klinik 2
Munich, Bavaria, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Martin Storr, Prof Dr. Medizinische Klinik 2 LMU Muenchen
  More Information

Additional Information:
Publications:
Responsible Party: Martin Storr, Prof Dr., Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01558284     History of Changes
Other Study ID Numbers: STO-010, 2011-002657-60
Study First Received: March 8, 2012
Last Updated: February 4, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:
Irritable bowel syndrome
Neu-P11
Melatonin
D-IBS

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 27, 2014