#1 Clinical Trials Search in Europe

Study of controlled-release nicotinamide (CICR-NAM) tablets for treating mild to moderate ulcerative colitis

4 1

What is this study about?

This study focuses on patients with ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. The research examines a new medication called CICR-NAM, which contains nicotinamide (a form of vitamin B3) in a special tablet form that releases the medicine in specific parts of the intestines.

The purpose of this research is to determine how well CICR-NAM works and how safe it is for treating mild to moderate ulcerative colitis. The study will compare CICR-NAM to a placebo over a period of 52 weeks. During the study, some participants will receive CICR-NAM tablets while others will receive placebo tablets.

The medication will be given as film-coated tablets that participants take by mouth. The treatment period is divided into two parts: the first 12 weeks will focus on initial improvement of symptoms, and the following 40 weeks will evaluate long-term benefits. The maximum daily dose of the medication will be 3 grams.

1 Initial treatment phase

You will receive either CICR-NAM tablets or placebo tablets (tablets without active medication) to take by mouth

This first phase of treatment lasts for 12 weeks

If you are currently taking 5-ASA medication (a common medication for ulcerative colitis), you will continue it at the same dose during this phase

2 First evaluation period

After 12 weeks, your condition will be evaluated through medical examination

The doctors will check your symptoms and perform tests to look at your intestines

They will assess if your condition has improved by examining your symptoms and conducting a visual examination of your intestinal lining

3 Extended treatment phase

If you continue in the study, the treatment will extend until week 52 (one year total)

You will continue taking either CICR-NAM or placebo tablets

If you are on 5-ASA medication, the dose may be reduced during this phase, but cannot be increased

4 Final evaluation

At week 52, your condition will be evaluated again

The doctors will check if you have achieved clinical remission (significant improvement in your condition)

They will perform examinations similar to those done at week 12 to assess your intestinal health

Who Can Join the Study?

  • Must be between 18 and 80 years old
  • Must have been diagnosed with ulcerative colitis for at least 3 months before screening
  • Must have experienced at least one disease flare-up in the past 12 months
  • Must have mild to moderate disease activity with:
    – Signs of rectal bleeding
    – Visible changes in the intestinal lining during endoscopy (examination of the bowel with a camera)
    – Increased stool frequency
  • Must have inflammation score greater than 4 on the Robarts Histology Index (a measure of disease activity seen under microscope)
  • Must have disease affecting an area larger than 15 centimeters from the anal opening
  • Regarding medication called 5-ASA (an anti-inflammatory drug):
    – If not taking 5-ASA in the past 2 weeks: can participate but cannot start during study
    – If currently taking 5-ASA: must have been taking it for more than 3 months, with stable dose for at least 4 weeks
    – Daily dose must not exceed 3 grams (brief exceptions up to 3 days allowed)
  • Both men and women can participate

Who Cannot Join the Study?

  • Age under 18 or over 65 years
  • Severe form of ulcerative colitis (a condition affecting the colon)
  • Pregnancy or breastfeeding
  • Current participation in other clinical trials
  • History of allergic reactions to similar medications
  • Major surgery in the past 3 months
  • Active or chronic infections
  • Serious heart, liver, or kidney problems
  • Cancer diagnosis within the last 5 years
  • Use of prohibited medications that could interfere with the study drug
  • Inability to follow study procedures or attend scheduled visits
  • History of substance abuse in the past 12 months
  • Mental health conditions that could affect study participation
  • Inflammatory bowel conditions other than ulcerative colitis
  • Abnormal laboratory test results that could indicate other health issues

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Gastroenterologie am Herrengarten Darmstadt Germany
Gastropraxis Magdeburg Magdeburg Germany
DRK Kliniken Berlin Berlin Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Gesundheit Nord gGmbH Klinikverbund Bremen Bremen Germany
Evangelisches Krankenhaus Kalk gGmbH Cologne Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gGmbH Bamberg Germany
Agaplesion Frankfurter Diakonie Kliniken gGmbH Frankfurt Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Gastropraxis an der St. Barbara-Klinik Hamm Germany
Ubtglnvzxj Muqqclr Cejuty Hoqpsgogdijmagufn Hamburg Germany
Mpbtzjiwyqdklvxoqbquzgvnps Hsnbfvxaeskqdtuj Halle (Saale) Germany
Upapzthwurnllvkexddeu Atnhrejv Augsburg Germany
Sdb Maaqsr Usf Stj Ahxdnnjoduszwrrvptqff Ludwigshafen Am Rhein Germany
Pnpsgpx Pjcwoibs frx Ghssoqtajhmjejbr Heidelberg Germany
Pyhtnpsa fzj Gvjwkceycyvlzqcx Hanover Germany
Gnlkeayplewwhcshbidf Swfvztowtscsyhvnz Pcqwt Dcv Lozuij &wmka Doj myjj Gfufwr Dornstadt Germany
Grqwvy Usecexpddh Fzkrelxfj Frankfurt Germany
Ufodkfconnsqmghhrdtmx Muhujqtu Afk Munster Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.08.2024

Trial locations

Investigated drugs:

CICR-NAM (Controlled-Ileocolonic-Release Nicotinamide) is an oral medication being studied for treating ulcerative colitis. It is a special form of nicotinamide (a form of vitamin B3) that is designed to be released specifically in the intestines. This controlled release system helps the medication reach the areas of the intestine affected by ulcerative colitis. The medication aims to reduce inflammation and improve symptoms in patients with mild to moderate ulcerative colitis.

A placebo is also used in this trial as a control substance. It looks identical to the active medication but contains no active ingredients.

Investigated diseases:

Ulcerative Colitis – A chronic inflammatory bowel disease that affects the large intestine (colon) and rectum. The condition causes inflammation and ulcers in the digestive tract’s innermost lining, leading to recurring episodes of abdominal pain, diarrhea, and bowel urgency. The inflammation typically begins in the rectum and can spread continuously to involve other parts of the colon. Symptoms tend to develop gradually and can range from mild to severe, with periods of active disease alternating with periods of remission. The condition may cause other symptoms such as fatigue, weight loss, and reduced appetite.

Trial ID:
2024-510807-13-00
Protocol code:
ORNATUS 1
NCT ID:
NCT06488625
Trial Phase:
Therapeutic use (Phase IV)

Other Trials to Consider

  • A study to evaluate the safety and effectiveness of MB-001 in adults with moderate to severe ulcerative colitis

    Recruiting

    1 1
    Investigated drugs:
    Poland

  • A study of mirikizumab levels in breast milk of breastfeeding women with ulcerative colitis or Crohn’s disease

    Recruiting

    3 1 1 1
    Investigated drugs:
    Denmark Germany Italy Poland Spain