A clinical trial to study the efficacy and safety of combination drugs of Pregabalin Prolonged Release and Etoricoxib in comparison to single therapy of Etoricoxib in patients having chronic low back pain in India.
- Conditions
- Health Condition 1: G892- Chronic pain, not elsewhere classified
- Registration Number
- CTRI/2018/10/015886
- Lead Sponsor
- Sun Pharma Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 319
1.Male or female patients of 18 to 65 years of age (both inclusive)
2.Patients with chronic low back pain (symptoms duration: greater than or equal to 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.Patient 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.Patient or his/her legally accepted representative is willing to give informed consent.
6.Female participants of childbearing potential must be willing to use acceptable method of contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilised, or has not had a hysterectomy at least three months prior to the start of this study. Acceptable method of contraception includes (e.g., barrier method with spermicide). The calendar method, withdrawal, or an IUD is NOT an acceptable method.
7.Patients willing to follow the study protocol.
1.Breast feeding or pregnant females
2.History of Hepatitis B, Hepatitis C or HIV infection
3.Anticonvulsants, antidepressants (eg tricyclic,tetracyclic,atypical),aspirin at doses greater than 81 mg/day,benzodiazepines,opioids,herbal medications,mexiletine HCl,epidural injection and procedure (eg 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 clinically significant cardiovascular disease (ex MI),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,severe hepatic and renal impairment(defined as either creatinine clearance less than 60 mL/min or renal dysfunction requiring hemodialysis),neoplastic disease, suicidal behavior,underlying conditions that may precipitate encephalopathy (ex liver failure),lactose intolerance,angle closure glaucoma,angioedema,urinary retention,thyroid disorder,uncontrolled hypertension and diabetes or abnormal ECG or the participant has any other abnormal laboratory value or MRI lumbosacral spine finding (eg neoplasia) of clinical significance for this study during screening visit
5.5.Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of Pregabalin Prolonged Release or Etoricoxib in the investigators judgment
6.Patients with known alcohol or other substance abuse within last one year as per DSM-5 criteria
7.Participant has hypersensitivity, intolerance, or contraindication to the use of Etoricoxib and Pregabalin, or any of its components
8.HbA1c greater than 8% at screening
9.Patient received treatment with an investigational device or compound within 6 months prior of the screening.
10.Patients with clinically significant disorder that, in the opinion of the investigator, would result in the participantâ??s inability to understand and comply with the requirements of the study
11.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 Mean change in Numeric Rating Scale (NRS) from enrolment to 8 weeksTimepoint: Mean change in Numeric Rating Scale (NRS) from enrolment to 8 weeks
- Secondary Outcome Measures
Name Time Method 1.Mean Change in Numeric Rating Scale (NRS) from enrolment to 4 weeks <br/ ><br>2.Mean change in Roland-Morris Disability Questionnaire (RDQ) from enrolment <br/ ><br>3.Mean change in Visual Analogue Scale (VAS) from enrolment <br/ ><br>4.Consumption of rescue medication (total dose of paracetamol tablets consumed)(post enrolment) <br/ ><br>5.Patient Global Impression of Improvement (PGI-I) <br/ ><br>6.Clinical Global Impression of Improvement (CGI-I) <br/ ><br>7.Proportion of participants with adverse events and serious adverse eventsTimepoint: 1.04 weeks <br/ ><br>2.04,08 weeks <br/ ><br>3.04,08 weeks <br/ ><br>4.04,08 weeks <br/ ><br>5.04,08 weeks <br/ ><br>6.04,08 weeks <br/ ><br>7.08 weeks