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

Phase 4

Not yet recruiting

• Conditions: Chronic pain syndrome,

• Registration Number: CTRI/2022/05/042521
• Lead Sponsor: Sun Pharma Laboratory Limited SPLL

Brief Summary

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|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.

Patientsdiscontinuing early from the study will be completing Visit 4 (Week 8)assessments. Visit 4 (Week 8) will be considered as end of treatment visit andend of study visit. The safety and efficacy will be assessed during the studyperiod.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-18
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

• 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.
• 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.
• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with adverse events and serious adverse events [Time frame: 08 weeks]	08 Weeks

Secondary Outcome Measures

Name	Time	Method
Following secondary endpoints will be evaluated	Efficacy

Trial Locations

Locations (12)

AIIMS; 🇮🇳 Puri, ORISSA, India

Dhawal Multispeciality Hospital; 🇮🇳 Vadodara, GUJARAT, India

DHS Multispeciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Gandhi Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Government Medical College & Government General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Hi-Tech Hospital; 🇮🇳 Malkangiri, ORISSA, India

Masina Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Maysore Medical College & Research Institute; 🇮🇳 Mysore, KARNATAKA, India

Oriion citicare superspeciality Hospital Aurangabad; 🇮🇳 Aurangabad, MAHARASHTRA, India

Shree Siddhivinayak Maternity & Nursing Home; 🇮🇳 Nashik, MAHARASHTRA, India

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AIIMS

🇮🇳Puri, ORISSA, India

Dr Sujit Kumar Tripathy

Principal investigator

9438884155

sujitortho@yahoo.co.in