Home » Trials » SLCTR/2013/020
Effect of Nifedipine slow release preparation in the treatment of primary dysmenorrhoea
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SLCTR Registration Number
SLCTR/2013/020
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Effect of Nifedipine slow release preparation in the treatment of primary dysmenorrhoea
Public Title of Trial
Use of Nifedipine to treat menstrula pain
Disease or Health Condition(s) Studied
Primary Dysmenorrhoea
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
698/12 (Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura)
What is the research question being addressed?
What is the role of Nifedipine (a calcium channel antagonist) in the primary management of dysmenorrhoea?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
This cross over study has three regimens of treatment. Participants will receive the following two drugs, as a single agent with a placebo or in combination. 1. Nifedipine (a calcium channel blocker) 2. Mefenemic acid (a Non-Steroidal Anti Inflammatory Drug) Formulation Nifedipine, 20 mg, slow release preparation is to be used for the study. The three regimens are as follows: 1. Nifedipine and placebo [N+P] 2. Mefenemic acid and placebo [M+P] 3. Mefenemic acid and Nifedipine [M+N].
The Principal Investigator will use a block randomization method to allocate sequential numbers to envelopes containing the treatment regimens, (N+P, M+P or M+N). Consenting patients will be randomly allocated the envelopes containing the treatment regimens.
Each patient shall take two types of tablets (one from each type), twice daily from the onset of the menstrual period for 7 days. The patient will be advised to stop the drugs at any point prior to 7 days if and when the patient is comfortable.If her pain is not relieved and still unbearable with the given treatment or extends beyond 7 days of commencing drug treatment,the patient will be advised to take Paracetamol, 1 gram, 6 hourly, as a rescue treatment and make a note in her treatment diary Please give details of cross-over
Each participant, after completion of 3 cycles of one regimen, will move on to the next regimen according to the initial block randomisation.
Each participant will go through all three regimens, 3 cycles each, for a total of 9 cycles.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
|
[ 1.At the end of each day of the cycle: by the patient 2.At the end of each menstrual cycle by the patient) 3.At the end of each regime (3 menstrual cycles): by the investigator ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
39
Countries of recruitment
Sri Lanka
Anticipated start date
2013-07-01
Anticipated end date
2016-06-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2013-02-28
Approval number
698/12
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Dhammike Silva
Senior Lecturer/ Consultant Obstetrician & Gynaecologist
Department of Obstetrics & Gynaecology, Faculty of Medical Sciences, University of Sri Jayewardenepura
0714 -469961
dammikesilva@yahoo.co.uk
Contact Person for Public Queries
Dr. Dhammike Silva
Senior Lecturer/ Consultant Obstetrician & Gynaecologist
Department of Obstetrics & Gynaecology, Faculty of Medical Sciences, University of Sri Jayewardenepura
0714 -469961
dammikesilva@yahoo.co.uk
Primary study sponsor/organization
Department of Obstetrics & Gynaecology, Faculty of Medical Sciences, University of Sri Jayewardenepura
Gangodawila, Nugegoda, Sri Lanka
2758611/ 2758613 [ext.8613]
http://www.medical.sjp.ac.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
