Clinical trial NCT01456052: A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis
Official title: Phase 2 Assessment of the Relationship Between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-10-20
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and preliminary effectiveness of two blinded dose levels of telotristat etiprate (LX1606) in participants with acute, mild to moderate ulcerative colitis on 5-aminosalicylic acid/mesalamine therapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ulcerative colitis of at least 6 months duration
* Disease extends at least 15 cm proximally from the anal verge, documented within the past 3 years
* Flare occurs on 5-aminosalicylic acid (5-ASA)/mesalamine therapy and subject is willing to remain on a stable dose for the duration of the study
* Age ≥18 and \<70 years of age
* Able and willing to provide written informed consent

Exclusion Criteria:

* Prior terminal ileum or colonic surgery, except appendectomy or hemorrhoid surgery
* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
* Clinical signs of fulminant colitis or toxic megacolon
* History of dysplasia associated lesion or mass (DALM)
* Subjects who have had surgery for ulcerative colitis, or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study
* History of primary sclerosing cholangitis
* Any physical or laboratory abnormality deemed by the investigator as clinically significant
* Major surgery within 60 days of Screening
* Use of any investigational agent within 30 days of Screening or any therapeutic protein or antibody within 90 days of Screening

Primary outcomes:
measure: Number of Participants Experiencing a Treatment Emergent Adverse Event
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Participants Achieving Clinical Response
timeFrame: Baseline to 8 weeks
measure: Number of Participants Achieving Clinical Remission
timeFrame: Baseline to 8 weeks
measure: Change From Baseline in Total Modified Mayo Score
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Lexicon Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Lexicon Investigational Site
state: California
city: Santa Monica
country: United States
facility: Lexicon Investigational Site
state: California
city: Great Neck
country: United States
facility: Lexicon Investigational Site
state: New York
city: New York
country: United States
facility: Lexicon Investigational Site
state: New York
city: Tulsa
country: United States
facility: Lexicon Investigational Site
state: Oklahoma
city: Houston
country: United States
facility: Lexicon Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Ogden
country: United States
facility: Lexicon Investigational Site
state: Utah
city: Sandy
country: United States
facility: Lexicon Investigational Site
state: Utah
city: Seattle
country: United States
facility: Lexicon Investigational Site
state: Washington
city: Kaunas
country: Lithuania
facility: Lexicon Investigational Site
city: Klaipeda
country: Lithuania
facility: Lexicon Investigational Site
city: Siauliai
country: Lithuania
facility: Lexicon Investigational Site
city: Vilnius
country: Lithuania
facility: Lexicon Investigational Site
city: Vilnius
country: Lithuania
facility: Lexicon Investigational Site
city: Krakow
country: Poland
facility: Lexicon Investigational Site
city: Lodz
country: Poland
facility: Lexicon Investigational Site
city: Sopot
country: Poland
facility: Lexicon Investigational Site
city: Warszawa
country: Poland
facility: Lexicon Investigational Site
city: Wroclaw
country: Poland
facility: Lexicon Investigational Site
city: Wroclaw
country: Poland
facility: Lexicon Investigational Site
city: Nitra
country: Slovakia
facility: Lexicon Investigational Site
city: Nove Mesto nad Vahom
country: Slovakia
facility: Lexicon Investigational Site
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Doug Fleming, MD
role: STUDY_DIRECTOR
References: