A randomized, double-blind, placebo-controlled, parallel arm group study to evaluate the analgesic efficacy and safety of dexketoprofen trometamol and tramadol hydrochloride oral fixed dose combination on moderate to severe acute pain in patients with acute low back pain – DANTE study - DANTE

Menarini International Operations Luxembourg SA0 sites538 target enrollmentMay 10, 2020

Conditionsow back pain MedDRA version: 21.0Level: LLTClassification code 10024891Term: Low back painSystem Organ Class: 100000004859 Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

DrugsLenizak Contramal

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ow back pain
Sponsor: Menarini International Operations Luxembourg SA
Enrollment: 538
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 10, 2020

End Date

May 4, 2022

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Menarini International Operations Luxembourg SA

Eligibility Criteria

Inclusion Criteria

•1\. Properly executed written informed consent.
•2\. Male or female patients aged 18 years to 65 years.
•3\. Patients with acute low back reporting pain of at least moderate intensity at Screening (NRS score \= 5\). The onset of the current acute low back pain episode is within 48 hours prior to Screening.
•4\. Patients with or without radiculopathy will be included, excluding those with neurological signs, according to the Quebec Task Force classification.
•5\. Naïve patients to any low back pain or patients with previous history of low back pain experiencing a new episode, preceded by a period of at least 2 months without any low back pain prior to Screening.
•6\. Patients free from analgesic (as per exclusion criterion 14\) due to previously administered pain killer (immediate or slow release formulations), according to physician’s judgment.
•7\. Females participating in the study must be either:
•\- Females of nonchildbearing potential, defined as any woman who had undergone surgical sterilization (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or is more than 2 years postmenopausal (defined as no menses for 12 months);
•\- Females of childbearing potential (following menarche until menopause unless permanently sterile) provided that they have a negative pregnancy test at Screening and are routinely using an effective method of birth control resulting in a low failure rate (ie, combined hormonal contraception, intrauterine device, condoms in combination with a spermicidal cream, male partner sterilization (vasectomy), bilateral tubal occlusion or total sexual abstinence) during the study treatment.
•8\. Mentally competent and able to understand and give written informed consent prior to Screening.

Exclusion Criteria

•1\. Patients who are judged by the Investigator not to be suitable candidates for the study treatments and the RM based on their medical history, physical examination, CM and concurrent systemic diseases.
•2\. Clinically significant abnormalities in the vital signs as per Investigator’s judgment.
•3\. Patients with acute low back pain and radiation to limb with presence of neurologic signs (focal weakness, asymmetry of reflexes, sensory loss in a dermatome, or loss of bowel, bladder, or sexual function) according to Quebec Task Force Classification.
•4\. History of hypersensitivity to the study treatments, RM or to any other nonsteroidal anti\-inflammatory drugs (NSAIDs), or opioids.
•5\. Known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates.
•6\. History of peptic ulcer, gastrointestinal disorders when taking NSAIDs, gastrointestinal bleeding, or other active bleeding.
•7\. History of allergy (eg, precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema) to the study treatments, RM or to any other NSAIDs, or opioids.
•8\. Anamnestic mild to severe renal dysfunction, mild to severe hepatic dysfunction, as per Investigator’s judgment.
•9\. Patients with chronic dyspepsia.
•10\. Patients with severe heart failure (Class III and Class IV of New York Heart Association \[NYHA] Classification).