| CTRI Number |
CTRI/2019/01/017335 [Registered on: 31/01/2019] Trial Registered Prospectively |
| Last Modified On: |
05/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A scientific Study to check the Safety and Effectiveness of Tablets ANAFORTAN-MF® in patients associated with pain in the lower abdomen occurring just before or during menstruation. |
|
Scientific Title of Study
|
A Prospective, Single-Arm, Open-Label Study to Determine the Safety and Effectiveness of ANAFORTAN-MF® Tablets (Fixed Dose Combination of Camylofin
Dihydrochloride 50 mg plus Mefenamic Acid I.P. 250 mg) in Primary Dysmenorrhea in India. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ANA-F-01-2017 Version 1.2, 12 Sept. 2017 |
Protocol Number |
| ANA-F-01-2017 Version 1.3, 01 Apr 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pragya Pandey |
| Designation |
Director |
| Affiliation |
Oriana Hospital |
| Address |
Department of Gynecology, Room 2, Oriana Hospital, B 27/35-9-A, Ravindrapuri
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9696519115 |
| Fax |
|
| Email |
orianacrvns@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Mr Gurumurthy S |
| Designation |
Manager – QA |
| Affiliation |
Accent Pharma |
| Address |
Accent Pharma,
Plot No. B-159, 22nd Cross,
PIPDIC Industrial Estate, Mettupalayam, Puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9750983636 |
| Fax |
|
| Email |
qapondy@accentpharma.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mr Satish Marukurthi |
| Designation |
CEO |
| Affiliation |
Croissance Clinical Research Pvt. Ltd. |
| Address |
402, Vasu Heights, Plot no. 91,92,93
Lumbini Avenue, Gachibowli
Hyderabad
TELANGANA
500032
India |
| Phone |
9515161468 |
| Fax |
|
| Email |
ceo@croissancecr.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Accent Pharma, Plot No. B-159, 22nd Cross,
PIPDIC Industrial Estate, Mettupalayam, Puducherry-605009 |
|
|
Primary Sponsor
|
| Name |
MS Accent Pharma |
| Address |
M/S Accent Pharma,
Plot No. B-159, 22nd Cross,
PIPDIC Industrial Estate, Mettupalayam, Puducherry-605009 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ayushi Asava |
Alliance Munot Hospital |
Division Alliance Munot Hospital, Department of Gynecology, Room-387/5, New Timber Market, Shankashet Road, Bhavani
Peth, Pune - 411042
Pune
MAHARASHTRA |
91-9922958766
aayushikabraasava@gmail.com |
| Dr Sudhanshu Kumar Rath |
Kalinga Institutes of Medical Sciences |
Room 101, Kalinga Institutes of Medical Sciences, Campus 5, KIIT University Bhubaneshwar 751024
Khordha
ORISSA |
9168479686
colskrath53@rediffmail.com |
| Dr Pragya Pandey |
Oriana Hospital |
Department of Gynecology, Room 2, Oriana Hospital, B 27/35-9-A, Ravindrapuri
Varanasi
UTTAR PRADESH |
9696519115
orianacrvns@gmail.com |
| Dr K Hemalatha |
Udhbhava Hospital |
Ittamadu, Banashankari 3rd Stage, Banashankari, Bengaluru, Karnataka 560085
Bangalore
KARNATAKA |
9844026294
hemalathanagaraj69@gmail.com |
| Dr Vijaya lakshmi Kodati |
Vasavi Medical and Research Center |
Vasavi Medical and Research Center
6-1-19, Lakdikapul, Khairatabad Market Road,Hyderabad 500004,Telengana
Hyderabad
TELANGANA |
9848030379
kovila@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| IEC of Sai Sneh Hospital and Diagnostics Center |
Approved |
| Kalinga Institutes of Medical Sciences |
Approved |
| Maruthi Independent ethics committee |
Approved |
| Oriana Hospital Ethics Committee |
Approved |
| Vasavi Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ANAFORTAN-MF® |
Fixed Dose Combination of Camylofin Dihydrochloride 50 mg + Mefenamic Acid I.P. 250 mg
Dosage and frequency: One tablet thrice daily
Route of administration: Orally
Total duration of therapy: 3 day treatment or 5 day treatment (Depends on physician discretion)
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Women ≥18 years of age with a history of moderate to severe primary dysmenorrhea during four or more of the previous six menstrual cycles
2. Women presenting with dysmenorrhea on the 1st or 2nd day of their current menstrual cycle
3. Women willing and able to provide written informed consent by signing the informed consent form (ICF) |
|
| ExclusionCriteria |
| Details |
1. Women with a history of taking Anafortan-MF® or any other prescription-only and/or nonprescription analgesics, antispasmodics, antidepressants, or antipsychotic medication (within the previous 4 weeks before study enrolment)
2. Pregnant or Lactating women
3. Women with organic dysmenorrhea (including the following etiologies: leiomyomata [fibroids], pelvic inflammatory disease, tubo-ovarian abscess, ovarian torsion, endometriosis)
4. Women using an intrauterine contraceptive device (IUCD)
5. Cognitive impairment, alcohol abuse, or psychiatric illness that would affect the ability of the patient to complete patient diary and other assessments
6. History of hypersensitivity to study drug (Anafortan-MF®)
7. Women who are allergic to (Anafortan-MF®) or any of the study drug ingredients, have undergone coronary artery bypass graft surgery, epilepsy, hypersensitivity, and/or inflammatory bowel disease
8. Any other illness or conditions that does not justify the woman’s participation in the study as judged by the Investigator
9. Woman not willing to comply with the study procedures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the safety of Anafortan-MF® in women with primary dysmenorrhea |
4 days or 6 Days (Depends on physician discretion) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of Anafortan-MF® on pain intensity through VAS scale for the treatment of women with primary dysmenorrhea To determine the effect of Anafortan-MF® on the frequency of daily pain episodes over a 3-day or 5-day course of treatment (as per physician’s discretion |
4 days or 6 days (Depends on physician discretion) |
|
|
Target Sample Size
|
Total Sample Size="274"
Sample Size from India="274"
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 4 |
|
Date of First Enrollment (India)
|
04/02/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
No any publication yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose:
Primary dysmenorrhea is one of the most frequent gynecological disorders affecting more than half of post-pubescent women. It interferes with daily activities, which affects women’s quality of life. The mainstay of treatment of primary dysmenorrhea includes various classes of NSAIDs, antispasmodics, and hormonal therapies. A combination of camylofin and mefenamic acid may provide better symptomatic relief by alleviating spasm and pain. However, there is a paucity of data on the safety and effectiveness of camylofin and mefenamic acid combination in a real-world setting for the treatment of pain associated with primary dysmenorrhea in women in the Indian population. In the present study, we aim to assess the safety and effectiveness of Anafortan-MF® (fixed-dose combination [FDC]) of camylofin 50 mg and mefenamic acid 250 mg) for the treatment of primary dysmenorrhea in Indian women.ial
Croissance Clinical Research is supporting to the end to end activities for this trials. |