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

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:

MedlinePlus related topics: Abdominal Pain

U.S. FDA Resources

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 ]

Estimated Enrollment:	532
Study Start Date:	July 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 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

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

Contacts

Contact: Hanneke van Assche	+31 (0)294 47 7367	hanneke.vanassche@abbott.com
Contact: Anita van der Laan	+31 (0)294 47 7263	anita.vanderlaan@abbott.com

Locations

China
Site reference ID/Investigator# 94519	Recruiting
Beijing, China, 100034
Site reference ID/Investigator# 94521	Recruiting
Guangzhou, China, 510080
Site reference ID/Investigator# 95475	Recruiting
Guangzhou City, China, 510515
Site reference ID/Investigator # 94516	Recruiting
Shanghai, China
Site reference ID/Investigator # 94517	Recruiting
Shanghai, China, 200433
Site reference ID/Investigator # 94518	Recruiting
Shanghai, China, 200127
Site reference ID/Investigator # 94515	Recruiting
Wuhan, China, 430022
Egypt
Site reference ID/Investigator# 95900	Recruiting
Cairo, Egypt
Site reference ID/Investigator# 95901	Recruiting
El Sharkya, Egypt
Site reference ID/Investigator# 95903	Recruiting
Giza, Egypt
Site reference ID/Investigator# 95902	Recruiting
Giza, Egypt
Mexico
Site reference ID/Investigaot# 94525	Recruiting
Guadalajara, Mexico, 49000
Site refernce ID/Investigator# 94527	Recruiting
Mexico City, Mexico, 54055
Site reference ID/Investigator# 94523	Recruiting
Tampico, Mexico, 89190
Poland
Site Reference ID/Investigator# 85297	Completed
Bialystok, Poland, 15-351
Site reference ID/Investigator# 85314	Completed
Bialystok, Poland, 15-270
Site Reference ID/Investigator# 85298	Completed
Bydgoszcz, Poland, 85-079
Site Reference ID/Investigator# 85293	Completed
Katowice, Poland, 40-031
Site Reference ID/Investigator# 85296	Completed
Lodz, Poland, 91-473
Site reference ID/Investigator# 85313	Completed
Olsztyn, Poland, 10-501
Site Reference ID/Investigator# 85295	Completed
Poznan, Poland, 60-193
Site Reference ID/Investigator# 85294	Completed
Poznan, Poland, 60-539

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:	May 16, 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
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Mebeverine
Bromides
Alverine
Pinaverium
Anticonvulsants

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013