NCT02260154

Brief Summary

Prospective, multicenter, non-comparative, observational program designed to assess the effectiveness of a 2-6 weeks treatment with Duspatalin® 200mg bis in die = twice a day (BID) and changes in quality of life in patients with post-cholecystectomy gastro-intestinal spasms

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 9, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

June 6, 2019

Completed
Last Updated

June 6, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

September 29, 2014

Results QC Date

December 5, 2017

Last Update Submit

March 1, 2019

Conditions

Post-cholecystectomy Gastrointestinal Spasms

Keywords

Duspatalinmebeverinecholecystectomygastrointestinal spasmabdominal paindyspepsiaantispasmodics

Outcome Measures

Primary Outcomes (1)

  • Percentage of "Responders" to Duspatalin® Therapy

    Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment

    2 weeks

Secondary Outcomes (10)

  • Percentage of "Responders" to Duspatalin® Therapy

    Up to 6 weeks

  • Changes in Abdominal Pain

    Baseline, 2 weeks and up to 6 weeks

  • Changes in Dyspepsia Symptoms

    Baseline, 2 weeks and up to 6 weeks

  • Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form

    Baseline to Week 2

  • Changes in Quality of Life

    Baseline, 2 weeks and up to 6 weeks

  • +5 more secondary outcomes

Study Arms (1)

Post-cholecystectomy gastrointestinal spasms

Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day

Drug: Mebeverine

Interventions

MebeverineDRUG

Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed

Also known as: Duspatalin
Post-cholecystectomy gastrointestinal spasms

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic

You may qualify if:

  • Male or female ≥ 18 years to 65 years;
  • Laparoscopic cholecystectomy between 6 months to 5 years before enrollment;
  • Patients having been prescribed Duspatalin® (mebeverine) 200 mg BID (bis in die = twice a day) in accordance with approved local label;
  • Patient's written authorization to provide data for the program

You may not qualify if:

  • General and specific contraindications to Duspatalin® treatment according to the local label;
  • Planned Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or surgical treatment;
  • Being currently treated or having been treated with Duspatalin® within the 6 weeks prior to entering the program;
  • Pregnancy or lactation;
  • Other conditions that make patient participation impossible (by investigator judgment);
  • Previous enrollment in the present program;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Research Facility ID ORG-001035

Chita, 672090, Russia

Location

State Budget Institution " Irkutsk State Medical Academy of postgraduate education"

Irkutsk, 664049, Russia

Location

Research Facility ID ORG-001038

Izhevsk, 426034, Russia

Location

Research Facility ID ORG-001033

Kazan', 420029, Russia

Location

Non-governmental Healthcare Institution "Road Clinical Hospital on the station Khabarovsk-1 OSS "Russian Railways"

Khabarovsk, 680022, Russia

Location

Research Facility ID ORG-001034

Krasnoyarsk, 660020, Russia

Location

Research facility ID ORG-001039

Moscow, 111123, Russia

Location

Federal State Budget Institution "Outpatient hospital №1" Administration of the President of the Russian Federation

Moscow, 119002, Russia

Location

State Budget Institution "Pirogov Russian National Research Medical University", on the base of State Budget Institution of Health Care of Moscow "City Clinical Hospital №31"

Moscow, 119415, Russia

Location

State Budget Institution "Russian Medical Academy of Postgraduate Studies

Moscow, 123836, Russia

Location

State Budget Institution of Health Care of Moscow region " MF Vladimirsky Moscow Region Scientific Research Clinical University"

Moscow, 129110, Russia

Location

Research Facility ID ORG-001024

Moscow, 129128, Russia

Location

State Budget Institution "Nizhny Novgorod Regional Clinical Hospital n.a. Semashko"

Nizhny Novgorod, 603126, Russia

Location

State Budget Institution "Novosibirsk State Medical University"

Novosibirsk, Russia

Location

Research Facility ID ORG-000903

Omsk, 644043, Russia

Location

Federal State Budget Institution Hospital of the Pushchino Scientific Center of the Russian Academy of Sciences

Pushchino, Russia

Location

Research Facility ID ORG-001036

Rostov-on-Don, 344022, Russia

Location

Federal State Budget Institution All-Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia

Saint Petersburg, 194044, Russia

Location

State Budget Institution "North-Western State Medical University named after I.I. Mechnikov", on the base of State Budget Institution "Sity Clinical Hospital #26"

Saint Petersburg, 196247, Russia

Location

Research Facility ID ORG-001037

Saransk, 430005, Russia

Location

City Clinical Hospital #40

Yekaterinburg, , 620102, Russia

Location

MeSH Terms

Conditions

Abdominal PainDyspepsia

Interventions

mebeverine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Results Point of Contact

Title
Tatiana V. Vladimirova MD, PhD
Organization
Abbott
tatiana.vladimirova@abbott.com
+7 495-258-4280

Study Officials

  • Tatiana Vladimirova, MD, PhD

    Abbott

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 9, 2014

Study Start

July 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

June 6, 2019

Results First Posted

June 6, 2019

Record last verified: 2019-03

Locations

RU(21)