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OpenTrials
Completed

NCT Number: NCT01678781

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Abdominal Pain Colonic Diseases Colonic Diseases, Functional Constipation Diarrhea Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site reference ID/Investigator# 94519, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: From baseline up to the week 8 visit

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

  • CHILTERN International GmbH

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 5, 2012
Registry last updated
Sep 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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