| CTRI Number |
CTRI/2019/12/022257 [Registered on: 05/12/2019] Trial Registered Prospectively |
| Last Modified On: |
05/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational phase IV clinical trial for treatment of Primary Dysmenorrhoea, Colic of an Oral Tablets of Fixed-dose Combination of Camylofin Dihydrochloride 50 mg and Paracetamol IP 325 without any comparator medicine to be conducted at different centers. |
|
Scientific Title of Study
|
An Open-label, Multicentric, Non-comparative, observational, Phase-IV Clinical Trial to
Evaluate Safety, Tolerability and Efficacy of Oral Tablets of Fixed-dose Combination of
Camylofin Dihydrochloride 50 mg and Paracetamol IP 325 mg in the treatment of Primary
Dysmenorrhoea, Colic†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Klab/CT/Camy_Para/012017 : Version 00 / Date: 26.04.2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devesh Kumar |
| Designation |
Director |
| Affiliation |
IR Innovate Research Private Limited |
| Address |
IR Innovate Research Pvt Ltd
Office Number B-1 Building D 13
Sector 3
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9971169602 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director |
| Affiliation |
IR Innovate Research Private Limited |
| Address |
IR Innovate Research Pvt Ltd
Office Number B-1 Building D 13
Sector 3
UTTAR PRADESH
201301
India |
| Phone |
9971169602 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director |
| Affiliation |
IR Innovate Research Private Limited |
| Address |
IR Innovate Research Pvt Ltd
Office Number B-1 Building D 13
Sector 3
UTTAR PRADESH
201301
India |
| Phone |
9971169602 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
|
Source of Monetary or Material Support
|
| Sponsor-Khandelwal laboratories pvt. Ltd
Address- 79/87 D.Ladpath Mumbai 400 033, India |
|
|
Primary Sponsor
|
| Name |
Khandelwal laboratories Pvt Ltd |
| Address |
79/87 D.ladpath Mumbai 400 033, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrinivas Gadappa |
Government Medical College |
University Road, Jubilee Park, Aurangabad, Maharashtra 431004
Aurangabad
MAHARASHTRA |
9822441553
gadappashrinivas@gmail.com |
| Dr Dipali Prasad |
Indira Gandhi Institute of Medical Sciences |
Room no. 1. 1st floor, Department of Gynecology.
IGIMS Patna,
Bailey Rd Raja Bazar Sheikhpura Patna Bihar 800014
Sheikhpura
BIHAR |
9708316233
dr.dipalipd@gmail.com |
| Dr Poonam Goyal |
Panchsheel Hospital |
C-3/63A, 64A, Yamuna Vihar Opp. Gokulpuri police station, Delhi -110053
North East
DELHI |
011-43541234
poonamgoyal29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee Panchsheel Hospital |
Approved |
| Institutional Ethics Committee Indira Gandhi Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, Government Medical College Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K808||Other cholelithiasis, (2) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fixed-dose Combination of Camylofin Dihydrochloride 50 mg and Paracetamol IP 325 mg |
Oral tablet, to be taken thrice a day for 4 days. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Subjects in the age group of 18-45 years (with painful menses)
2) Written and/or witnessed informed consent to participate in the trial was taken prior to initiating the study from the parent and/ or the legally accepted representative.
3) Patients who had at least 6 months previous history of confirmed diagnosis of Primary Dysmenorrhoea, colic
|
|
| ExclusionCriteria |
| Details |
1) Not willing to sign ICF
2) Patients known, or thought to be hypersensitivity, to study drugs
3) Pregnant and lactating women
4) Patients with a history of hypersensitivity to Camylofin or Paracetamol
5) Patients with prostatic hypertrophy
6) Patients with glaucoma
7) Patients with mechanical stenosis
8) Patients with serious underlying organic disorders
9) Patients with paralytic ileus
10) Patients with renal or hepatic disorders
11) Patients with previous history of heart problems or stroke
12) Participation in other clinical trials the last three months and doing study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Primary objective of this Phase IV trial is to find out safety & tolerability of the product |
Day 5 (after 4 days of therapy) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objective of this Phase IV trial is to find out efficacy of the product by clinical global impression |
Day 5 (after 4 days of therapy) |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/12/2019 |
| Date of Study Completion (India) |
17/11/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
is a phase IV observational, multicentric, open lable, single arm, non
comparator study to evaluate the safety and efficacy of Fixed-dose
Combination of Camylofin Dihydrochloride 50mg and Paracetamol IP 325mg in the treatment
of Primary Dysmenorrhoea, which is an oral tablet.
The
FDC is to be taken thrice daily for 4 days. The evaluation is done on the basis
of – AE during the study period, The efficacy will be assessed by Clinical
Global Impression scale done by Investigator.
The
study is conducted in India and about 200 subjects will be enrolled in this
study.The study duration is approximately 6 months. |