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

March 8, 2012
February 4, 2014
February 2012
January 2014   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Only one question at the end of each visit and of each telephone call
Same as current
Complete list of historical versions of study NCT01558284 on ClinicalTrials.gov Archive Site
Not Provided
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The Effect of Neu-P11 on Symptoms in Patients With D-IBS
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

Patients with diarrhea-praedominant Irritated Bowel Syndroms

Diarrhea- Irritable Bowel Syndrome
  • 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
Not Provided
Storr M. [Therapy of gastroesophageal reflux disease (GERD)]. Med Monatsschr Pharm. 2011 Dec;34(12):446-54; quiz 455-6. Review. German.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01558284
STO-010, 2011-002657-60
Yes
Martin Storr, Ludwig-Maximilians - University of Munich
Ludwig-Maximilians - University of Munich
Not Provided
Principal Investigator: Martin Storr, Prof Dr. Medizinische Klinik 2 LMU Muenchen
Ludwig-Maximilians - University of Munich
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP