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

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ClinicalTrials.gov Identifier: NCT01678781
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : September 9, 2013
Sponsor:
Collaborator:
CHILTERN International GmbH
Information provided by (Responsible Party):
Abbott

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.

Condition or disease
Irritable Bowel Syndrome

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Study Type : Observational
Actual Enrollment : 607 participants
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
Study Start Date : July 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Group/Cohort
One patient group
Patients suffering from irritable bowel syndrome



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change in abdominal pain [ Time Frame: From baseline up to the week 8 visit ]
  2. Change in bloating [ Time Frame: From baseline up to the week 8 visit ]
  3. Change in feeling of abdominal distension [ Time Frame: From baseline up to the week 8 visit ]
  4. Change in stool frequency [ Time Frame: From baseline up to the week 8 visit ]
  5. Change in stool form [ Time Frame: From baseline up to the week 8 visit ]
  6. Change in straining of evacuation [ Time Frame: From baseline up to the week 8 visit ]
  7. Change in urgency of evacuation [ Time Frame: From baseline up to the week 8 visit ]
  8. Change in feeling of incomplete evacuation [ Time Frame: From baseline up to the week 8 visit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678781


Locations
Show Show 24 study locations
Sponsors and Collaborators
Abbott
CHILTERN International GmbH
Investigators
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Study Director: Guenter Krause Abbott

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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01678781    
Other Study ID Numbers: P13-678
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: September 9, 2013
Last Verified: September 2013
Keywords provided by Abbott:
Abdominal pain
Diarrhea
Mebeverine hydrochloride
Constipation
Pinaverium bromide
Irritable bowel syndrome
Bloating
Quality of life
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pinaverium
Bromides
Mebeverine
Alverine
Anticonvulsants
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents