NCT01678781

Brief Summary

A study to evaluate, by country and overall, the changes from baseline of the irritable bowel syndrome quality of life (IBS QoL) total score after 4 and 8 weeks of treatment with Duspatalin® or Dicetel® in IBS patients.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
607

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Geographic Reach
4 countries

24 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

July 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 9, 2013

Status Verified

September 1, 2013

Enrollment Period

1.1 years

First QC Date

July 13, 2012

Last Update Submit

September 6, 2013

Conditions

Irritable Bowel Syndrome

Keywords

Abdominal painDiarrheaMebeverine hydrochlorideConstipationPinaverium bromideIrritable bowel syndromeBloatingQuality of life

Outcome Measures

Primary Outcomes (1)

  • Change in Irritable Bowel syndrome (IBS) quality of life (QoL) measure (IBS-QoL) to assess the impairment of QoL in IBS patients

    From baseline up to the week 8 visit

Secondary Outcomes (8)

  • Change in abdominal pain

    From baseline up to the week 8 visit

  • Change in bloating

    From baseline up to the week 8 visit

  • Change in feeling of abdominal distension

    From baseline up to the week 8 visit

  • Change in stool frequency

    From baseline up to the week 8 visit

  • Change in stool form

    From baseline up to the week 8 visit

  • +3 more secondary outcomes

Study Arms (1)

One patient group

Patients suffering from irritable bowel syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic, community sample

You may qualify if:

  • Irritable bowel syndrome patients diagnosed by Rome III criteria (18 years or older)

You may not qualify if:

  • Pregnancy and lactation
  • Specific contraindications to mebeverine hydrochloride or pinaverium bromide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Site reference ID/Investigator# 94519

Beijing, 100034, China

Location

Site reference ID/Investigator# 94521

Guangzhou, 510080, China

Location

Site reference ID/Investigator# 95475

Guangzhou, 510515, China

Location

Site reference ID/Investigator # 94518

Shanghai, 200127, China

Location

Site reference ID/Investigator # 94517

Shanghai, 200433, China

Location

Site reference ID/Investigator # 94516

Shanghai, China

Location

Site reference ID/Investigator # 94515

Wuhan, 430022, China

Location

Site Reference ID/Investigator# 95908

Alexandria, Egypt

Location

Site reference ID/Investigator# 95900

Cairo, Egypt

Location

Site reference ID/Investigator# 95901

El Sharkya, Egypt

Location

Site reference ID/Investigator# 95902

Giza, Egypt

Location

Site reference ID/Investigator# 95903

Giza, Egypt

Location

Site Reference ID/Investigator# 95906

Port Said, Egypt

Location

Site reference ID/Investigaot# 94525

Guadalajara, 49000, Mexico

Location

Site refernce ID/Investigator# 94527

Mexico City, 54055, Mexico

Location

Site reference ID/Investigator# 94523

Tampico, 89190, Mexico

Location

Site reference ID/Investigator# 85314

Bialystok, 15-270, Poland

Location

Site Reference ID/Investigator# 85297

Bialystok, 15-351, Poland

Location

Site Reference ID/Investigator# 85298

Bydgoszcz, 85-079, Poland

Location

Site Reference ID/Investigator# 85293

Katowice, 40-031, Poland

Location

Site Reference ID/Investigator# 85296

Lodz, 91-473, Poland

Location

Site reference ID/Investigator# 85313

Olsztyn, 10-501, Poland

Location

Site Reference ID/Investigator# 85295

Poznan, 60-193, Poland

Location

Site Reference ID/Investigator# 85294

Poznan, 60-539, Poland

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeAbdominal PainDiarrheaConstipation

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Guenter Krause

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2012

First Posted

September 5, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 9, 2013

Record last verified: 2013-09

Locations

EG(6)ME(3)PL(8)CN(7)