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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01678781

Enrollment

607

Registered

2012-09-05

Start date

2012-07-31

Completion date

2013-08-31

Last updated

2013-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Abdominal pain, Diarrhea, Mebeverine hydrochloride, Constipation, Pinaverium bromide, Irritable bowel syndrome, Bloating, Quality of life

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Change in urgency of evacuation	From baseline up to the week 8 visit
Change in feeling of incomplete evacuation	From baseline up to the week 8 visit
Change in abdominal pain	From baseline up to the week 8 visit
Change in straining of evacuation	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
Change in bloating	From baseline up to the week 8 visit

Countries

China, Egypt, Mexico, Poland

Outcome results