CTRI/2022/05/042521 [Registered on: 12/05/2022] Trial Registered Prospectively
Last Modified On:
22/08/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
A study to check safety and efficacy of Pregabalin Prolonged Release and Etoricoxib Tablet in patients with Chronic Low Back Pain Associated with Neuropathic Component
Scientific Title of Study
A Phase IV, Multi-Centric Study to Evaluate Safety and Efficacy of Fixed Dose Combination of Pregabalin Prolonged Release and Etoricoxib Tablets in Patients Having Chronic Low Back Pain Associated with Neuropathic Component
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
Protocol No.: ICR/20/015 Version: 2.0 Date: 10 Mar 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President - Global Clinical Operations
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
91-2717-698500
Fax
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Nil Desai
Designation
Senior Manager Medical Services
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
919879732959
Fax
Email
nhdesai@cliantha.com
Details of Contact Person Public Query
Name
Mr Devesh Verma
Designation
Associate Director-I
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
919712908404
Fax
Email
dverma@cliantha.com
Source of Monetary or Material Support
Sun Pharma Laboratory Limited (SPLL), Mumbai
Primary Sponsor
Name
Sun Pharma Laboratory Limited SPLL
Address
Sun House, Plot No. 201, B/1, Western Highway, Goregoan (E) , Mumbai 400063, Maharashtra, India.
Dept. of Orthopedic, Main building, Ground floor, OPD room, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar-751019,Odisha, India Puri ORISSA
9438884155
sujitortho@yahoo.co.in
Dr Kaushik Rana
Dhawal Multispeciality Hospital
39/40 Sahjanand Society, Harni - Warasiya Ring Rd Vadodara GUJARAT
9909502349
Kaushik.cr@gmail.com
DrSwagat Shah
DHS Multispeciality Hospital
Vastrapur lake -Himalaya mall link road, vastrapur, Ahmadabad GUJARAT
9033711363
dr.swagatshah@gmail.com
DrB Valya
Gandhi Hospital
Ground Floor, IP Block, Dept of Orthopedics, Gandhi Hospital, Musheerabad, Hyderabad TELANGANA
9000357799
orthovalya@gmail.com
Dr K Sanjeev Kumar
Government Medical College & Government General Hospital
Department of Orthopaedics, OPD 3, Ground Floor, Government Medical College & Govt General Hospital (Old RIMSGGH), Srikakulam – 532001, Andhra Pradesh, India Srikakulam ANDHRA PRADESH
7702288992
drsanjeevkumarkare@yahoo.com
Dr Brijesh Patel
Hi-Tech Hospital
Room No. 03, Ground Floor, Sector 3-D, Plot No. 1180, Gh Road, Nr. Gh-11/2 Bus Stand, Gandhinagar GUJARAT
9825686088
hitechhospital.cr@gmail.com
Dr Manoj Madini
Hi-Tech Hospital
Department of orthopedic, Ground floor, room no. 43, Hi-tech Medical College & Hospital, Hi-tech Hospital Road, Pandara, Rasulgarh, Bhubaneswar-751025, Odisha Malkangiri ORISSA
7504115598
sujitortho@yahoo.co.in
Dr Chirag Borana
Masina Hospital
Main Building,second floor, Clinical research department, Masina Hospital, Sant Savta Marg,Byculla (East), Mumbai MAHARASHTRA
9890511760
drchiragb@gmail.com
Dr Paramesha KC
Maysore Medical College & Research Institute
Room no 3,Department of Orthopedics, K R Hospital Attached to Mysore Medical College and Research Institute, Irwin Road, Mysuru Karnataka, India-570001 Mysore KARNATAKA
Pregabalin Prolonged Release and Etoricoxib tablet
Drug: Combination of Pregabalin prolonged release and Etoricoxib tablet
Dose: 75 + 60 mg
Route of administration: Orally Frequency: once-daily after an evening meal.
Duration of therapy: 08 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patients of either gender, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study at the time of screening
2. Patients with chronic low back pain (symptoms duration: ≥ 3 months) and at least one of the following features on the side corresponding to leg pain:
a. Sharp and shooting pain below the knee;
b. Pain evoked by straight leg raising to 60 degrees or less;
c. Decreased or absent ankle reflex;
d. Weakness of muscles below the knee.
e. Sensory loss in L5/S1 distribution
3. Patients who have pain score of at least 4 on a Numeric Rating Scale (11- point)
4. Patients who agree not to use any other approved or experimental pharmacological treatments for low back pain, other than mentioned in the protocol, at any time during the study.
5. Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least 7 days after the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence)
[Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Post-menopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age.]
6. Patients willing to follow the study protocol
7. A male patient must agree to use adequate contraception from study entry till at least 7 days after the last dose of the study medication.
ExclusionCriteria
Details
1 Pregnant or lactating woman
2 Patients with history of HIV and/or HBV and/ or HCV
3 Anticonvulsants, antidepressants (e.g. tricyclic, tetracyclic, atypical), aspirin at doses >81 mg/day, benzodiazepines, opioids, herbal medications, mexiletine HCl, epidural injection and procedure (e.g. acupuncture) performed within 6 weeks prior to screening or planning to use during the study or taken more than recommended doses of any dosage form of NSAIDs analgesics in last 15 days prior to screening and any treatment for low back pain within 2 days prior to enrolment.
4 Patients who, in the opinion of the investigator, have history of/ or currently suffering with clinically significant conditions listed as below and not limited to:
• cardiovascular disease (e.g. MI, uncontrolled hypertension (≥140 / 90 mmHg), New York Heart Association (NYHA) class II - IV); cerebrovascular disease (e.g. stroke)
• psychiatric disorders as per DSM-5 (Bipolar disorder, generalized anxiety disorder, depression, psychosis or post-traumatic stress disorder); epilepsy or seizure disorder requiring treatment with anti-epileptic drugs; suicidal behavior
• renal impairment (defined as either creatinine clearance < 60 mL/min or renal dysfunction requiring haemodialysis); hepatic impairment (Child-Pugh score > 6)
• respiratory depression; active peptic ulceration or active GI bleeding; inflammatory bowel diseases; peripheral arterial disease; neoplastic disease; lactose intolerance; angioedema, hypersensitivity reaction, thyroid disorder; and diabetes (HbA1c > 8% at screening)
• myopathy; blurred vision
5 Patients with any clinically significant lab abnormalities/ condition which in the opinion of investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements.
6 Patients with tumorigenic potential as per investigator’s discretion
7 Patients with known alcohol or any substance abuse within last one year as per DSM-5 criteria
8 Pre-planned surgery or medical procedure that would interfere with the conduct of the study
9 Patients with history of hypersensitivity to any of the study drug or to drugs of similar chemical classes or to any of its excipients
10 Patients who has participated in another investigational study within 30 days prior to screening in this study or planning to participate during the study
11 Employee of the sponsor, investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees of sponsor or the investigator.
12 Patients operating heavy complex machinery or who intend to drive
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Proportion of participants with adverse events and serious adverse events [Time frame: 08 weeks]
08 Weeks
Secondary Outcome
Outcome
TimePoints
Following secondary endpoints will be evaluated
Efficacy
1. Mean change in Numeric Rating Scale (NRS) from enrolment to end of 4 weeks, 8 weeks
2. Mean change in Roland–Morris Disability Questionnaire (RDQ) from enrolment to end of 4 weeks, 8 weeks
3. Mean change in Visual Analogue Scale (VAS) from enrolment to end of 4 weeks, 8 weeks
4. Consumption of rescue medication (total dose of paracetamol tablets consumed) (post enrolment) [Time frame: 04, 08 weeks]
04 Weeks, 08 Weeks
Target Sample Size
Total Sample Size="185" Sample Size from India="185" 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)
18/05/2022
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="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Nill
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is phase IV, multicenter, single arm study. The study will
be conducted at 10-15 centers in India, having qualified Investigators. The
study will be initiated only after the receipt of regulatory and ethics
committee (EC) approval.
After obtaining the informed consent, patients will be screened
via various assessments as mentioned in Schedule of Assessment (Appendix I)
and eligible patients will be enrolled and patient number will be given.
Patients will be given FDC of Pregabalin Prolonged Release + Etoricoxib
tablets (75 mg + 60 mg) for 08 weeks (Treatment period).
During the study, assessments will be performed as mentioned in
Schedule of Assessment (Appendix I).
The study has following visits:
Visit 1: Screening Visit (Day -14 to Day -1, Week -3 to Week
-1),
Visit 2: Enrolment/Baseline Visit (Day 1, Week 1)
Visit 3: Day 28 ± 4 (Week 4)
Visit 4: End of Study Visit, End of Treatment Visit/ Early
Termination Visit: Day 56 ± 4 (Week 8)
Patients will be provided with diary to record details about
study drug administration, rescue medication, adverse events. Patients will
be required to bring completed diary at each visit.
Patients
discontinuing early from the study will be completing Visit 4 (Week 8)
assessments. Visit 4 (Week 8) will be considered as end of treatment visit and
end of study visit. The safety and efficacy will be assessed during the study
period.