ROMERUS: Multicenter Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT03549143

Collaborator

(none)

1,000

Enrollment

Locations

15.8

Actual Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome	Other: IBS

Detailed Description

Awareness about the disease in Russia is extremely low both among doctors and especially among patients. To date there are no data on the prevalence of the disease in Russia. This is the first study to show patient profile, main trigger factors and concomitant diseases among patients with Irritable Bowel Syndrome (IBS) in Russia. Also treatment characteristics for these patients in Russia will be measured. This study fills a lack of scientific data about prevalence of IBS and additional information.

Study Design

Study Type:

Observational

Actual Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Multicenter Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation

Actual Study Start Date :

Dec 25, 2017

Actual Primary Completion Date :

Apr 19, 2019

Actual Study Completion Date :

Apr 19, 2019

Outcome Measures

Primary Outcome Measures

Proportion of patients with IBS according to Rome IV Diagnostic Criteria by sex [Baseline]
Proportion of patients with IBS according to Rome IV Diagnostic Criteria by education [Baseline]
Proportion of patients with IBS according to Rome IV Diagnostic Criteria by region of living [Baseline]
Proportion of patients with IBS according to Rome IV Diagnostic Criteria by marriage status [Baseline]
Proportion of patients with IBS according to Rome IV Diagnostic Criteria by type of IBS [Baseline]

Secondary Outcome Measures

Findings of routine examination [6 months]
proportion of patients with confirmed IBS by routine examination among all patients met Rome IV criteria
Comorbidity [Baseline]
Proportion of patients with different diagnosis registered at baseline
Routine treatment regimens [Baseline, 6 months]
Proportion of patients received each treatment
Absolute score of the IBS symptoms measured by IBS-QoL scale [Baseline, 1, 2, 4, and 6 months]
Irritable Bowel Syndrome - Quality Of Life (IBS-QOL) questionnaire contains 34 questions assessed from 1 point = "not at all" till 5 point = "a great deal". The sum of all items is used to calculate the total score. All items are negative framed with the greatest response scale equaling the worst QoL. Scores for all items are transformed to a 0 to 100 scale, ranging from 0 (worst QoL) to 100 (best QoL).
Changes from baseline of the IBS symptoms measured by IBS-QoL scale [Baseline, 1, 2, 4, and 6 months]
Irritable Bowel Syndrome - Quality Of Life (IBS-QOL) questionnaire contains 34 questions assessed from 1 point = "not at all" till 5 point = "a great deal". The sum of all items is used to calculate the total score. All items are negative framed with the greatest response scale equaling the worst QoL. Scores for all items are transformed to a 0 to 100 scale, ranging from 0 (worst QoL) to 100 (best QoL). Positive change corresponds to better outcome.
Assesment by Global Patient Assessment scale [1, 2, 4, and 6 months]
Global Patient Assessment contains one question to rate up patient's general complaints of GI-discomfort. A 5-point Likert scale is used as follow: 'symptom-free, markedly improved, slightly improved, unchanged, worse'.
Assesment by Physician Global Assessment scale [1 and 6 months]
Physician Global Assessment contains one question to rate up patient's general complaints of GI-discomfort. A 5-point Likert scale is used as follow: 'symptom-free, markedly improved, slightly improved, unchanged, worse'.
Adherence to treatment [up to 6 months]
The national questionnaire of treatment compliance contains 5 questions with 4 answers each. The sum of all items is used to calculate the total score. The total score has the range from 0 (worst compliance) to 15 (best compliance).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female 18-50 y.o
Patients suffering from Irritable bowel syndrome (abdominal pain and changes in bowel habit) as defined by Rome IV criteria and the absence of any relevant structural disease
Patient's written authorization to provide data for the program
Patients who are able to input him/herself data into patients' part of Electronic Data Capture (EDC)

Exclusion Criteria:

Presence of alarm features:

positive family history of colorectal cancer, inflammatory bowel disease, celiac disease
rectal bleeding in the absence of documented bleeding hemorrhoids or anal fissures
unintentional weight loss
severe anemia (according to local laboratory reference values)
Fever (> 37,5 degree Celsius)
Night symptoms appearance

Other:

Significant and progressive change in: enlargement of the liver, spleen, lymph nodes; ascites; palpable mass in the abdomen / pelvic
Pregnancy or lactation or the inability to use adequate contraception during the study;
Other conditions that made the patients participation impossible (by investigator judgment)
Previous enrollment in any other clinical study during the course of this study, including participation in a study within 30 days prior to informed consent.
Prescribed by Health Care Professional(s) (HCP) and being currently treated or having been treated with spasmolytics within the 3 months prior to entering the study.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	City Clinical Hospital #8	Chelyabinsk	Russian Federation	454007
2	Railway Clinical Hospital	Irkutsk	Russian Federation	664005
3	City Clinical Hospital #4	Ivanovo	Russian Federation	153005
4	The First Republican Clinical Hospital of MoH UR	Izhevsk	Russian Federation	426039
5	Interregional Clinical Diagnostic Center	Kazan	Russian Federation	420101
6	Medical Center "Dobryj Doctor"	Kemerovo	Russian Federation	650000
7	Branch Hospital AT ST. Krasnodar JSC "RZD"	Krasnodar	Russian Federation	350072
8	The Medical ON Group Lyubertsy	Lyubertsy	Russian Federation	140002
9	Institute of Health	Lyubertsy	Russian Federation	140013
10	SM-Clinic	Lyubertsy	Russian Federation	140013
11	Multidisciplinary Medical Clinic	Moscow	Russian Federation	111123
12	Research Institute of gastroenterology	Moscow	Russian Federation	111123
13	Medical Center 'Golden Orchid'	Moscow	Russian Federation	111675
14	Outpatient Dpt of City Clinical Hospital #85	Moscow	Russian Federation	115409
15	Blokhin Oncology Center	Moscow	Russian Federation	115522
16	9 MDC Ministry of Defense	Moscow	Russian Federation	119021
17	Medical Center on Timur Frunze Street	Moscow	Russian Federation	119021
18	MEDSI Clinic	Moscow	Russian Federation	123056
19	CP Litfonda	Moscow	Russian Federation	125319
20	Diamed Clinic	Moscow	Russian Federation	125368
21	MC Larmed	Moscow	Russian Federation	125475
22	Clinic 'Medic City'	Moscow	Russian Federation	127220
23	MSMSU them. A. I. Evdokimov	Moscow	Russian Federation	127473
24	CPM LLC	Novosibirsk	Russian Federation	630090
25	LLC Multidisciplinary Medical Center ALTAME+	Odintsovo	Russian Federation	143006
26	LLC Industrial Medicine Clinic, polyclinic No1	Orenburg	Russian Federation	46000
27	Treatment and Rehabilitation Center No1	Rostov-on-Don	Russian Federation	344011
28	Medi Com LLC (SM-clinic)	Saint Petersburg	Russian Federation	195279
29	LLC 'Avesta MDC-M'	Saratov	Russian Federation	410028
30	Stavropol Regional Clinical Diagnostic Center	Stavropol	Russian Federation	355017
31	OKD Diagnostic Center	Surgut	Russian Federation	628415
32	Consulvative and Diagnostic Center Endos	Tyumen	Russian Federation	625026
33	Kuvatov RCH	Ufa	Russian Federation	450005
34	Diamed Llc	Vladivostok	Russian Federation	690087
35	MC Medic LLC	Yekaterinburg	Russian Federation	620014
36	MC Chance LLC	Yekaterinburg	Russian Federation	620143
37	LLC "Medical Center" Doctor Plus	Yekaterinburg	Russian Federation	6220018

Sponsors and Collaborators

Abbott

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abbott

ClinicalTrials.gov Identifier:

NCT03549143

Other Study ID Numbers:

EPIDI060

First Posted:

Jun 7, 2018

Last Update Posted:

Apr 25, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Abbott

IBS; Irritable Bowel Syndrome; spasmolytics; mebeverine; Duspatalin

Additional relevant MeSH terms:

Irritable Bowel Syndrome

Syndrome

Study Results

No Results Posted as of Apr 25, 2019