| CTRI Number |
CTRI/2010/091/001106 [Registered on: 06/08/2010] |
| Last Modified On: |
21/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Open label Prospective Non Comparative Phase III Study for Efficacy and Safety of FDC of Ispaghula Husk IP 3.5g and Lactitol Monohydrate BP 10g Granules, in the treatment of Acute Idiopathic Constipation.
|
|
Scientific Title of Study
|
Open label Prospective, Non Comparative, Phase III Study for Efficacy and Safety of FDC of Ispaghula Husk and Lactitol Monohydrate Granules,in the treatment of Acute Idiopathic Constipation. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NEX/AKUM/CTIII-101/05/10 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Bhambe |
| Designation |
|
| Affiliation |
|
| Address |
NARENDRA PRAKASH HEALTH CARE CENTER,
DA-3/A, MAIN SHAKAR PUR,LAXMINAGAR,
New Delhi
DELHI
110 092
India |
| Phone |
+919654807949 |
| Fax |
|
| Email |
drdeepakdhambe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Bhatt |
| Designation |
|
| Affiliation |
Nexus Clinical Research Pvt Ltd |
| Address |
Anuj, Plot No. 45, Ist Floor,
Mumbai-Pune Highway, Near D. Y. Patil Stadium, Sector-13, Nerul (E),
Mumbai
MAHARASHTRA
400 706
India |
| Phone |
+91-22-27714204 |
| Fax |
ext 108 |
| Email |
dramit.bhatt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr R. Prasad |
| Designation |
|
| Affiliation |
|
| Address |
General Manager, Akums Drugs and Pharmaceuticals Ltd
304, Mohan Place, LSC, Block ? C, Saraswati Vihar
New Delhi
DELHI
110 034
India |
| Phone |
091 11 47511000 |
| Fax |
091 11 27023256 |
| Email |
prasad@akums.net |
|
|
Source of Monetary or Material Support
|
| Akums Drugs & Pharmaceuticals Ltd |
|
Primary Sponsor
Modification(s)
|
| Name |
Akums Drugs Pharmaceuticals Limited |
| Address |
304
Mohan Place
LSC
Block C
Saraswati Vihar
Delhi 110034 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohan Pai |
Managalore heart Centre |
No.8 City point, ,Kodiabail-575003
Bangalore
KARNATAKA |
09845083135
mohanpai@rediff.com |
| 3) DR. DEEPAK BHAMBE |
NARENDRA PRAKASH HEALTH CARE CENTER |
DA-3/A, ,MAIN SHAKAR PUR-110 092
New Delhi
DELHI |
09654807946
drdeepakbhambe@gmail.com |
| DR. SAURABH SINGH |
RAMAKRISNA MOTHER AND CHILD CLINIC |
C-2/96,,NEW KONDLI-110 096
New Delhi
DELHI |
09711112080
docsaurabh76@rediffmail.com |
| 5) DR. PRAKASH REGE |
Rege Clinic |
B-1, 56/57/58, SUBHASH NAGAR,TEEN DONGRI, M.G.ROAD, GOREGAON (W)-400 062
Mumbai
MAHARASHTRA |
09223477294
p_p_rege@yahoo.co.in |
| 1) DR. TANURAJ SIROHI |
SIROHI CLINIC |
CHIPPI TANK,-250 001
Meerut
UTTAR PRADESH |
09917000583
trsirohi@yahoo.com |
| Dr Satish Gupta |
SOMDATT POLY CLINIC |
S-524,SCHOOL BLOCK, LAXMI NAGAR,-110 092
New Delhi
DELHI |
09811212494
kumar6511@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acute Idiopathic Constipation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC Of Ispaghula Husk IP 3.5g And Lactitol Monohydrate BP 10g Granules |
Seven Days Twice A day |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of both sexes , aged between 18-50 years
Subjects with acute idiopathic constipation(defined as presence of less than three stools per week and/or straining at stool for at least three months) who have one or more of the following symptoms associated with at least 25% of bowel movements (BMs) for at least 3 months prior to the baseline visit: very hard (little balls) and/or hard stools, a sensation of incomplete evacuation, or straining at defecation.
|
|
| ExclusionCriteria |
| Details |
Documented mechanical obstruction, megacolon/megarectum or a diagnosis of pseudoobstruction
Hypersensitivity to lactitol, Ispaghula Husk or any other constituents of the investigational product.
Known or suspected organic disorders of the large or small intestine.
Secondary causes of constipation.
Hospitalization for any gastrointestinal or abdominal surgical procedure during the 3 months before the start of the study.
Prior bowel resection.
Clinically significant cardiovascular, liver, lung, or other systemic disease; neurologic or psychiatric disorders.
Cancer within the past 5 yr
Women of childbearing potential who cannot use oral or implanted contraceptives or to have used a double-barrier method during the trial.
Breast feeding women.
Any other illness which could seriously effect the safety of subjects and /or the integrity of the study
Subjects who, within the past 30 days have participated in an investigational clinical study.
Subjects currently taking, or planning to take any of the following medications that are known to effect bowel habits:
Antidiarrheals
Antacids containing magnesium or aluminum salts
Anticholinergics
Antispasmodic agents
Erythromycin and other macrolides
Opiods/narcotic analgesics
Prokinetics
Serotonin re-uptake inhibitors or tricyclic antidepressants
Calcium antagonists. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of fixed dose combination of Ispaghula Husk IP 3.5g and Lactitol Monohydrate BP 10g Granules in the treatment of Acute Idiopathic Constipation. |
day 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of fixed dose combination of Ispaghula Husk IP 3.5g and Lactitol Monohydrate BP 10g Granules in the treatment of Acute Idiopathic Constipation. |
day 7 |
| Proportion of subjects with full response to treatment at the end of follow up phase.
2. The frequency of SBMs during 1st week of treatment;
Time-to-first SBM
|
proportion of subjects with a SBM within 24 and 48 h of first study drug administration |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
12/07/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be conducted after obtaining written informed consent from 200 subjects with Acute Idiopathic Constipation who will be enrolled and complete the protocol therapy of 7 days. The subjects will undergo medical screening during pre-study visit (Visit 1). Screening will include complete clinical evaluation (medical history, physical examination, record of height, weight and vital signs). Female subjects of child bearing capability will be subjected to a urine pregnancy test.
Enrolled subjects will receive the medication for 7 days (Visit 2). At visit 3 (day 7) end of therapy efficacy, safety, tolerability and ADR monitoring will be done. Subjects are allowed to visit to investigator at any time point during the study.
this study is open An Open label Prospective Non Comparative Phase III Study for Efficacy and Safety of FDC of Ispaghula Husk IP 3.5g and Lactitol Monohydrate BP 10g Granules, in the treatment of Acute Idiopathic Constipation. This study is done for the DCGI marketing approval and the product will be marketed in India after the clearance form the regulatory authorities |