| CTRI Number |
CTRI/2025/03/082417 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Lubiprostone and Prucalopride for Chronic Idiopathic constipation(constipation without a known cause)- Which one works better and is safer? |
|
Scientific Title of Study
|
A Comparative Evaluation Of The Effectiveness And Safety Of Lubiprostone And Prucalopride In Patients With Chronic Idiopathic Constipation: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shine Sadasivan |
| Designation |
MD DNB Gastroenterology |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Amrita Institute of Medical Sciences and Research Centre Ponekkara PO Kochi Kerala 682041
Ernakulam
KERALA
682041
India |
| Phone |
9497556339 |
| Fax |
|
| Email |
shines1560@aims.amrita.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms. Meenu Vijayan |
| Designation |
Assistant Professor, Department of Pharmacy Practice |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Amrita School of Pharmacy, Amrita Institute of Medical Sciences and Research Centre Ponekkara PO Kochi Kerala 682041
Ernakulam
KERALA
682041
India |
| Phone |
7907989335 |
| Fax |
|
| Email |
meenu.vijayan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shine Sadasivan |
| Designation |
MD DNB Gastroenterology |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Amrita Institute of Medical Sciences and Research Centre Ponekkara PO Kochi Kerala 682041
KERALA
682041
India |
| Phone |
9497556339 |
| Fax |
|
| Email |
shines1560@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita School of Pharmacy Amrita Institute of Medical Sciences and Research Centre Ponekkara PO Kochi Kerala |
|
|
Primary Sponsor
|
| Name |
Amrita School of Pharmacy |
| Address |
Amrita Institute of Medical Sciences and Research Centre Ponekkara PO Kochi Kerala 682041 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHINE SADASIVAN |
Amrita Institute of Medical Sciences and Research Centre |
Amrita Institute of Medical Sciences and Research Centre Ponekkara PO Kochi Kerala 682041
Ernakulam
KERALA |
9497556339
shines1560@aims.amrita.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee, Amrita Institute of Medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K590||Constipation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LUBIPROSTONE |
Lubiprostone is a laxative medication that treats chronic constipation. It is a Chloride channel protein 2 (ClC-2) activator leading to increased fluid secretion and faster movement of stool through the small intestine and colon.
Tab. Lubiprostone 24 mcg 1-0-0(once daily) for 3 weeks |
| Intervention |
PRUCALOPRIDE |
Prucalopride acts as a selective stimulator of the 5-HT4 receptors.Prucalopride stimulates motility by interacting specifically with 5-HT4 receptors in the GI tract which causes a release of acetylcholine and further contraction of the muscle layer of the colon and relaxation of the circular muscle layer leading to the propulsion of luminal content. Commonly used for chronic constipation
Tab. Prucalopride 2mg 1-0-0 (once daily) for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with chronic idiopathic constipation
Patients between ages 18 to 80 years( male and female)
|
|
| ExclusionCriteria |
| Details |
Patients with Mechanical bowel obstruction
Patients with Drug Induced Constipation
Secondary causes for constipation such as Hypothyroidism, Cardio vascular disease, Malignancies, etc.
Pregnant and Lactating women
Other bowel disease such as IBD. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in Spontaneous Bowel Movement per week |
Within 3 week of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine any ADR and its severity |
Within 3 weeks of treatment |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Randomized Controlled Trial in the department of
Gastroenterology to evaluate Effectiveness
and Safety of Lubiprostone Versus Prucalopride in Patient with Idiopathic
Constipation. All patient who satisfies the inclusion and exclusion
criteria will be selected for the study.
Intervention (Prucalopride)
and Comparator(Lubiprostone) treatment will be randomized and given to the patients, and data
will be collected during follow up and via telecommunication
Data
collection form will be completed Data
will be transferred to an excel sheet
Descriptive
statistics will be used for analysis of the data.
Statistical Details To
test the statistically significant change in the frequency of spontaneous bowel
movement per week, PAC-SYM score, Bristol Stool Scale, Naranjo’s causality
assessment scale, Hartwig’s severity scale before and after between the two
groups. Independent sample t-test for normal data or Mann- Whitney U test for
skewed data will be applied |