| CTRI Number |
CTRI/2024/07/070750 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Milk Of Magnesia+Liquid Paraffin+Sodium Picosulfate In The Management Of Constipation Post Ano-Rectal Surgery Patients |
|
Scientific Title of Study
|
A Prospective, Multicentric Study, To Evaluate The Effectiveness And Safety Of Milk Of Magnesia+Liquid Paraffin+Sodium Picosulfate In The Treatment Of Constipation Symptoms In Post Ano-Rectal Surgical Patients |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MAPS-522-0270 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pravin Gore |
| Designation |
Principal Investigator |
| Affiliation |
Piles Freedom Clinic |
| Address |
Piles Freedom Clinic,
RB2 Central Railway Quarters, Sion West, Sion, Mumbai-400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9821253131 |
| Fax |
|
| Email |
drpravingore@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Acharya |
| Designation |
Director Clinical Development & Operation |
| Affiliation |
Abbott India Limited |
| Address |
Floor 16, Godrej BKC
Plot No C-68,
Bandra Kurla Complex,
Bandra East,
Mumbai-400051,
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
8657552543 |
| Fax |
|
| Email |
shivani.acharya@abbott.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Acharya |
| Designation |
Director Clinical Development & Operation |
| Affiliation |
Abbott India Limited |
| Address |
Floor 16, Godrej BKC
Plot No C-68,
Bandra Kurla Complex,
Bandra East,
Mumbai-400051,
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
8657552543 |
| Fax |
|
| Email |
shivani.acharya@abbott.com |
|
|
Source of Monetary or Material Support
|
| Abbott India Limited
3, Corporate Park,
Sion- Trombay Park,
Mumbai-400071, Maharashtra. |
|
|
Primary Sponsor
|
| Name |
Abbott India Limited |
| Address |
3, Corporate Park,
Sion- Trombay Park,
Mumbai-400071, Maharashtra. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Praveen Sharma |
Charak Hospital & Research Centre |
Tondan Marg, near Safed Masjid, Dubagga, Lucknow, U.P. 226003
Lucknow
UTTAR PRADESH |
8288966688
Span.pravin@gmail.com |
| Dr Suraj Kumar Pattnayak |
Government Medical College and General Hospital, Srikakulam |
Srikakulam ,Balaga, 1st Ward, Srikakulam Town,
Srikakulam Dist.
Andhra Pradesh
Srikakulam
ANDHRA PRADESH |
9642725480
gghsrikakulam@gmail.com |
| Dr Praveen Gore |
Piles Freedom Clinic |
RB2 Central Railway Quarters, Sion West, Sion, Mumbai-400022
Mumbai (Suburban)
MAHARASHTRA |
9821253131
drpravingore@gmail.com |
| Dr Sreejoy Pattanaik |
Shanti Memorial Hospital |
Patnaik colony, Thoria Sahi, Cuttack-753001, Odisha
Khordha
ORISSA |
9437024550
sreejoypatnaik@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Charak Hospital & Research Centre |
Approved |
| Ethics Committee Shanti Memorial Hospital |
Approved |
| IEC GMC and GGH Srikakulam |
Approved |
| Suraksha – Ethics Committee |
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 |
| Intervention |
Fixed-dose oral formulation containing the milk of magnesia, liquid paraffin, and sodium picosulphate |
In this PMOS, post-ano-rectal surgical patients with symptoms of constipation will be prescribed fixed-dose oral formulation of milk of magnesia, liquid paraffin, and sodium picosulphate oral emulsion, at a dose of 7.5 ml (1½ teaspoon) at bedtime preferably with water or as directed by the investigator, for a period of 15 days.
Each 5 ml contains —Milk Of Magnesia (3.75 ml) + Sodium Picosulfate (3.33 Mg) + Liquid Paraffin (1.25 ml) |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Post-ano-rectal surgery (anal fissures, anal fistulas, and hemorrhoids) patients of either sex, in the age group of ≥18 and ≤65 years.
2. Patients having symptoms of constipation for a minimum of 3 days before the day of surgery.
3. Women of childbearing potential who had a negative pregnancy test were non-lactating and were willing to use adequate throughout the study.
4. Patients willing to comply with study procedures and requirements.
5. Patients who understood the requirements of the study and were willing to sign and date the informed consent form before participating in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients with a history/ongoing congestive heart failure, severe hepatic or renal dysfunction, or neurological conditions (like Parkinson’s disease, multiple sclerosis, sacral nerve damage, and paraplegia or autonomic neuropathy).
2. Pregnant or lactating women.
3. Patients with ingestion of laxatives or any drug affecting GI motility in the last 3 days or known hypersensitivity, as per the discretion of the investigator at screening.
4. Patients not willing to provide written informed consent to be excluded.
5. Patients with ongoing intestinal obstruction, ileus, toxic megacolon gastric retention abdominal pain, nausea or vomiting, ongoing irritable bowel syndrome (IBS) with constipation at screening.
6. Patients with history/ongoing psychiatric conditions.
7. Patients with active or cured malignancies.
8. Patients with a history of hypersensitivity to liquid paraffin, magnesium hydroxide, or sodium picosulfate.
9. Patients with any medical condition judged by investigators that warrant exclusion at screening.
10. Patients who have been on any laxatives containing, Milk of Magnesia, Liquid paraffin, and Sodium Picosulfate in the last 2 weeks. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To determine the effectiveness of fixed-dose formulation of milk of magnesia, liquid paraffin, and sodium picosulphate oral emulsion in the treatment of constipation symptoms in post-ano-rectal surgical patients. |
Day 0, 4 and 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the treatment response in terms of bowel symptom relief after 4±2: days and 15-day treatment with fixed-dose formulation of milk of magnesia, liquid paraffin, and sodium picosulphate oral emulsion in post-ano-rectal surgical patients.
2. To determine the impact of treatment with the fixed-dose formulation of milk of magnesia, liquid paraffin, and sodium picosulphate oral emulsion on the quality of life (QoL) of patients using the Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL). |
Day 0, 4 and 14 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
29/07/2024 |
| Date of Study Completion (India) |
15/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This
is a prospective, multicenter, single-arm, open-label, post-marketing
observational study designed to evaluate the effectiveness and safety of
fixed-dose oral formulation containing the milk of magnesia, liquid paraffin,
and sodium picosulphate (Cremaffin-Plus®, Abbott India Limited) oral emulsion
in the management of constipation in Indian patients, post-ano-rectal surgery. This
multicenter study will enroll 80 patients, with constipation symptoms
post-anorectal surgery. The patients will be followed up for 15 (±1 day) days
after enrollment into the study. The selection of patients for the study will
be totally at the discretion of the investigator, and as per the study
protocol. All the patients diagnosed with symptoms of constipation post
anorectal surgery, meeting inclusion and exclusion criteria, and ready to give
written informed consent for study participation, are eligible for
participation in this study. The study is planned to be conducted for
approximately Six (6)- months. |