Open International Study on Quality of Life in Irritable Bowel Syndrome (IBS) Patients Before and After 8 Weeks Treatment With Mebeverine/Pinaverium Bromide

This study has been completed.
Sponsor:
Collaborator:
CHILTERN International GmbH
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01678781
First received: July 13, 2012
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition
Irritable Bowel Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Open International Study on Quality of Life in IBS Patients Before and After 8 Weeks Treatment With Mebeverine/Pinaverium Bromide

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Change in Irritable Bowel syndrome (IBS) quality of life (QoL) measure (IBS-QoL) to assess the impairment of QoL in IBS patients [ Time Frame: From baseline up to the week 8 visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in abdominal pain [ Time Frame: From baseline up to the week 8 visit ] [ Designated as safety issue: No ]
  • Change in bloating [ Time Frame: From baseline up to the week 8 visit ] [ Designated as safety issue: No ]
  • Change in feeling of abdominal distension [ Time Frame: From baseline up to the week 8 visit ] [ Designated as safety issue: No ]
  • Change in stool frequency [ Time Frame: From baseline up to the week 8 visit ] [ Designated as safety issue: No ]
  • Change in stool form [ Time Frame: From baseline up to the week 8 visit ] [ Designated as safety issue: No ]
  • Change in straining of evacuation [ Time Frame: From baseline up to the week 8 visit ] [ Designated as safety issue: No ]
  • Change in urgency of evacuation [ Time Frame: From baseline up to the week 8 visit ] [ Designated as safety issue: No ]
  • Change in feeling of incomplete evacuation [ Time Frame: From baseline up to the week 8 visit ] [ Designated as safety issue: No ]

Enrollment: 607
Study Start Date: July 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
One patient group
Patients suffering from irritable bowel syndrome

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic, community sample

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy and lactation
  • Specific contraindications to mebeverine hydrochloride or pinaverium bromide
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678781

Locations
China
Site reference ID/Investigator# 94519
Beijing, China, 100034
Site reference ID/Investigator# 94521
Guangzhou, China, 510080
Site reference ID/Investigator# 95475
Guangzhou City, China, 510515
Site reference ID/Investigator # 94516
Shanghai, China
Site reference ID/Investigator # 94518
Shanghai, China, 200127
Site reference ID/Investigator # 94517
Shanghai, China, 200433
Site reference ID/Investigator # 94515
Wuhan, China, 430022
Egypt
Site Reference ID/Investigator# 95908
Alexandria, Egypt
Site reference ID/Investigator# 95900
Cairo, Egypt
Site reference ID/Investigator# 95901
El Sharkya, Egypt
Site reference ID/Investigator# 95902
Giza, Egypt
Site reference ID/Investigator# 95903
Giza, Egypt
Site Reference ID/Investigator# 95906
Port Said, Egypt
Mexico
Site reference ID/Investigaot# 94525
Guadalajara, Mexico, 49000
Site refernce ID/Investigator# 94527
Mexico City, Mexico, 54055
Site reference ID/Investigator# 94523
Tampico, Mexico, 89190
Poland
Site Reference ID/Investigator# 85297
Bialystok, Poland, 15-351
Site reference ID/Investigator# 85314
Bialystok, Poland, 15-270
Site Reference ID/Investigator# 85298
Bydgoszcz, Poland, 85-079
Site Reference ID/Investigator# 85293
Katowice, Poland, 40-031
Site Reference ID/Investigator# 85296
Lodz, Poland, 91-473
Site reference ID/Investigator# 85313
Olsztyn, Poland, 10-501
Site Reference ID/Investigator# 85294
Poznan, Poland, 60-539
Site Reference ID/Investigator# 85295
Poznan, Poland, 60-193
Sponsors and Collaborators
Abbott
CHILTERN International GmbH
Investigators
Study Director: Guenter Krause Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01678781     History of Changes
Other Study ID Numbers: P13-678
Study First Received: July 13, 2012
Last Updated: September 6, 2013
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
China: Ethics Committee
Egypt: Ministry of Health and Population
Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Abbott:
Abdominal pain
Diarrhea
Mebeverine hydrochloride
Constipation
Pinaverium bromide
Irritable bowel syndrome
Bloating
Quality of life

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Alverine
Bromides
Mebeverine
Pinaverium
Anticonvulsants
Autonomic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014