NCT01149200

Brief Summary

Study is to assess the effectiveness of TC-6499 in the treatment of constipation predominant IBS patients over a 28-day period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

December 2, 2013

Status Verified

November 1, 2013

Enrollment Period

5 months

First QC Date

June 14, 2010

Last Update Submit

November 27, 2013

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel SyndromeIBS-C

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in global IBS symptom relief score

    Primary efficacy endpoint assessed weekly using patient's response to a global symptom relief question rating their relief of IBS symptoms over the past week compared to before study entry.

    28 days

Secondary Outcomes (2)

  • Weekly number of spontaneous bowel movements (SBM)

    28 days

  • Severity of pain, bloating, degree of straining, and stool consistency

    28 days

Study Arms (2)

TC-6499

EXPERIMENTAL
Drug: TC-6499

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TC-6499DRUG

5mg enteric-coated oral hard gelatin capsule, administered twice daily

TC-6499
PlaceboDRUG

placebo as enteric-coated oral hard gelatin capsule, administered twice daily

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men with IBS-C (ROME III) between 18 and 65 years of age, inclusive.
  • Women with IBS-C (ROME III) between 55 and 65 years of age, or 18 to 55 years of age with documentation of non-childbearing potential status (surgical sterilization or one year post last menses with elevated FSH/LV).
  • All subjects should have a body mass index (BMI) between 18 and 34 kg/m2, inclusive and a body weight of not less than 45 kg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Quotient Clinical Ltd

Edinburgh, United Kingdom

Location

Quotient Clinical Ltd

Ruddington, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Stuart Mair, MB, ChB

    Quotient Bioresearch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2010

First Posted

June 23, 2010

Study Start

May 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

December 2, 2013

Record last verified: 2013-11

Locations

GB(2)