| CTRI Number |
CTRI/2017/03/008113 [Registered on: 16/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
19/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study comparing the effects and side effects of milnacipran and pregabalin in patients with chronic pain condition known as fibromyalgia |
|
Scientific Title of Study
|
Effectiveness and safety of pregabalin versus milnacipran in patients with fibromyalgia – A randomized open label post marketing study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirmal George |
| Designation |
Assistant Professor |
| Affiliation |
Sree Gokulam Medical College and Research Foundation |
| Address |
Department of Pharmacology
Sree Gokulam Medical College and Research Foundation
Venjaramoodu
Karinchathi road
Venjaramoodu
Thiruvananthapuram
KERALA
695607
India |
| Phone |
|
| Fax |
|
| Email |
nirmalgeorge.ng@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nirmal George |
| Designation |
Assistant Professor |
| Affiliation |
Sree Gokulam Medical College and Research Foundation |
| Address |
Department of Pharmacology
Sree Gokulam Medical College and Research Foundation
Venjaramoodu
Karinchathi Road
Venjaramoodu
Trivandrum
Thiruvananthapuram
KERALA
695607
India |
| Phone |
|
| Fax |
|
| Email |
nirmalgeorge.ng@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nirmal George |
| Designation |
Assistant Professor |
| Affiliation |
Sree Gokulam Medical College and Research Foundation |
| Address |
Department of Pharmacology
Sree Gokulam Medical College and Research Foundation
Venjaramoodu
Karinchathi road
Venjaramoodu
Thiruvananthapuram
KERALA
695607
India |
| Phone |
|
| Fax |
|
| Email |
nirmalgeorge.ng@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nirmal George
Assistant Professor
Department of Pharmacology
Sree Gokulam Medical College and Research Foundation
Venjaramoodu
Trivandrum
695607 |
|
|
Primary Sponsor
|
| Name |
Nirmal George |
| Address |
Assistant Professor
Department of Pharmacology
Sree Gokulam Medical College and Research Foundation
Venjaramoodu
Trivandrum
695607 |
| Type of Sponsor |
Other [Investigator initiated] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| NIRMAL GEORGE |
Sree Gokulam Medical College and Research Foundation |
Sree Gokulam Medical College and Research Foundation
Venjaramoodu
Thiruvananthapuram
KERALA |
8129900220
nirmalgeorge.ng@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sree Gokulam Medical College and Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M797||Fibromyalgia, Patients diagnosed with fibromyalgia using modified ACR 2010 criteria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Milnacipran |
50-100mg/day orally (stable dose) |
| Comparator Agent |
Pregabalin |
150-300 mg/day orally (stable dose) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects diagnosed as having fibromyalgia according to 2010 ACR diagnostic criteria for fibromyalgia |
|
| ExclusionCriteria |
| Details |
1.Subjects not willing to take part in the study.
2.Major depressive or psychiatric disorder, suicidal tendency or ideation.
3.Pregnancy
4.Lactation
5.Uncontrolled hypertension
6.Hepatic dysfunction
7.History of glaucoma
8.Patients receiving MAO inhibitors (eg: selegeline)
9.Cardiac failure (NYHA class III-IV)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in modified Fibromyalgia Impact Questionnare (FIQR)score from baseline. |
2 months, 3 months of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in brief pain inventory (BPI) score from baseline. |
2 months, 3 months of treatment. |
| Change in Medical Outcomes Study (MOS) sleep scale score from baseline. |
2 months, 3 months of treatment. |
| Change in Sheehan Disability scale (SDS) score from baseline. |
2 months, 3 months of treatment. |
| Adverse events associated with milnacipran and pregabalin |
Through out the study |
| Analysis of symptoms and laboratory abnormalities associated with fibromyalgia. |
Baseline |
| Discontinuation of study medications and reason for discontinuation. |
Through out the study |
| Incremental cost effectiveness ratio (ICER) of treatment regimens |
2 months, 3 months |
| Comparison of absolute Fibromyalgia Impact Questionnare (FIQR)score |
Baseline, 2 months, 3 months of treatment. |
| Comparison of absolute brief pain inventory (BPI) score. |
Baseline, 2 months, 3 months of treatment. |
| Comparison of absolute Medical Outcomes Study (MOS) sleep scale score. |
Baseline, 2 months, 3 months of treatment. |
| Comparison of absolute Sheehan Disability scale (SDS) score. |
Baseline, 2 months, 3 months of treatment. |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/03/2017 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Subjects diagnosed as having fibromyalgia by the neurologist will be enrolled after explaining the study details to the patients and obtaining written informed consent and will be randomized to open label milnacipran or pregabalin according to computer generated block randomization. Dose titration and attainment of a stable dose will be done in 1 month. Modified Fibromyalgia Impact Questionnare (FIQR), Brief pain inventory (BPI), Medical Outcomes study (MOS) sleep scale score, Sheehan Disability Scale (SDS) score will be recorded in case record forms at baseline, 2 months of treatment and 3 months of treatment. Safety of milnacipran and pregabalin will be assessed through out the study by monitoring Adverse Drug Reactions and causality will be assessed using WHO Adverse Drug reaction monitoring criteria. |