NCT01855711

Brief Summary

This study is an exploratory study aiming (i) to obtain clinical experience of GR68755 in Japanese subjects with severe d-IBS to explore the feasibility of the next phase study and (ii) to obtain reference data for endpoints and dosage and administration of a next phase study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2003

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

September 18, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2005

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

May 14, 2013

Last Update Submit

April 28, 2017

Conditions

Irritable Colon

Keywords

Alosetron hydrochlorideGlobal Improvement Scale(GIS)Diarrhea-predominant IBS

Outcome Measures

Primary Outcomes (2)

  • Global Improvement Scale(GIS)

    four weeks

  • Satisfactory control of IBS related bowel urgency

    four weeks

Secondary Outcomes (4)

  • Adequate relief of IBS pain and discomfort

    four weeks

  • Days without abdominal pain and discomfort

    four weeks

  • Severity score of abdominal pain and/or discomfort

    four weeks

  • Intestine function(Number of bowel movement,Stool form,Feeling of incomplete evacuation,Abdominal bloating)

    four weeks

Study Arms (1)

GR68755 (Alosetron hydrochrolide) group

EXPERIMENTAL

GR68755 1 mg tablets QD in the morning every day for 28 days

Drug: GR68755 (Alosetron hydrochloride) 1 mg tablet

Interventions

GR68755 (Alosetron hydrochloride) 1 mg tabletDRUG

1 tablet (1 mg) once a day

GR68755 (Alosetron hydrochrolide) group

Eligibility Criteria

Age20 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Disease to be treated: Has been diagnosed with severe d-IBS (at least 6 months of d-IBS symptoms as defined by the Rome II Criteria), and failed conventional IBS therapy.
  • The following criteria (2. and 3.) will be confirmed at the end of screening phase (before assigning the investigational products) based on the record in the diary card.
  • Meets both (1) and (2) during the 1-week screening phase. (1)Has recorded symptom data on at least 6 days in the diary card during the screening phase. In case of patient whose screening phase is 5 days, has recorded symptom data on all days (5 days) in the diary card during the screening phase (2)An average stool consistency score recorded in the diary card during the screening phase is \>=3.0.
  • Stool consistency score
  • = very hard
  • = hard
  • = formed
  • = loose
  • = watery 3.Meets both the following (1) and (2):
  • (1)Average "severity of abdominal pain or discomfort" score recorded in the diary card during the screening phase is \>=1.0 (2)Has frequent "bowel urgency" (has urgency \>= 50% of the days during the screening phase) Severity of pain or discomfort score
  • = mild
  • = moderate
  • = intense
  • = severe However, if the subject did not experience abdominal pain or discomfort, score zero (0).
  • Age: Is 20-64 years of age 5.Sex: Female 6.Type of subject: Outpatient 7.Is ambulatory (not depending on a wheelchair for mobility) 8.Is not pregnant, lactating, or intend to become pregnant during the study period.
  • +10 more criteria

You may not qualify if:

  • Does not have severe d-IBS
  • Has current evidence of or history of chronic or severe constipation, or a history of sequelae from constipation.
  • Is currently constipated or did report no stool for three or more consecutive days during the screening phase.
  • Has evidence of bloody diarrhea or abdominal pain with lower gastrointestinal hemorrhage.
  • Has current evidence of uncontrollable cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, hematologic, or digestive condition (excluding IBS).
  • Has evidence of biochemical or structural abnormality of the digestive tract.
  • These conditions include the evidence or history of the following:
  • Ischemic colitis
  • Impaired intestinal circulation
  • gastrointestinal perforation
  • gastrointestinal obstruction and/or stricture
  • diverticulitis
  • Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
  • Microscopic colitis (lymphocytic colitis, collagenous colitis), or celiac sprue
  • Laxative abuse (in the clinical judgement of the investigator/subinvestigator) or melanosis coli.
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

alosetronTablets

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 16, 2013

Study Start

September 18, 2003

Primary Completion

May 10, 2005

Study Completion

May 10, 2005

Last Updated

May 1, 2017

Record last verified: 2017-04