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Completed

NCT Number: NCT00417391

Phase II Study of RR110 in Patients With Active Crohn's Disease

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics profile of 1 and 4 mg/kg/day RR110 administrated orally for 8 weeks in patients with active Crohn's disease.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Toyohashi, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with CDAI score ranging from 220 to 450
  • Patients with CRP > 1 mg/dL
  • Patients who can be hospitalized at least 2 weeks after first administration

Exclusion criteria

  • Patients who have previously used anti-TNF antibody, cyclosporine, methotrexate or tacrolimus within 12 weeks of screening
  • Patients who have had surgical bowel resections within 4 weeks of screening
  • Patients who have previously used total parental nutrition or more than 900 kcal/day of enteral nutrition within 4 weeks of screening

Treatment and study plan

RR110 (Tamibarotene)

Drug

1 mg RR110

Other names: Tamibarotene, Am80

Primary outcomes

  1. Change in Crohn's disease active index (CDAI) score

    Time frame: 8 weeks

Secondary outcomes

  1. Rate of clinical response as defined by CDAI decrease > 70 or 100 from baseline

    Time frame: 8 weeks

  2. Rate of clinical remission as defined by CDAI < 150

    Time frame: 8 weeks

  3. Change in CRP, SAA, and fibrinogen levels, and IBDQ and CDEIS scores

    Time frame: 10 weeks

  4. Safety parameters

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

R&R Inc.

Industry

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 1, 2007
Registry last updated
May 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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