Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low Back Pain

NCT05170841 | Completed Phase 4 Results

• 2 other identifiers: MEIN/18/DEX-LBP/0012019-003656-37
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, study to evaluate the analgesic efficacy and safety of Dexketoprofen trometamol and Tramadol hydrochloride combination versus placebo on moderate to severe acute pain in patients with acute low back pain.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Time to First Achieve a Numeric Rating Scale-Pain Intensity Score <4 or a Pain Intensity Reduction of ≥30% From Drug Intake Till 8 Hours After the First Dose

  Time to first achieve a Numeric Rating Scale-Pain Intensity (NRS-PI) score of \<4 or a pain intensity reduction ≥30% from drug intake till 8 hours after the first dose. Numeric Rate Scale-Pain Intensity is a Patients rated Pain Intensity scale using an 11-point Numeric Rate Scale (0 no pain; 10 worst pain).

  8 hours from first intake (referring to first 8 hours of Single Dose Phase)

Secondary Outcomes (25)

• Total Pain Relief (TOTPAR) at 4h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol

  From t=o to T=4 hours

• Total Pain Relief (TOTPAR) at 6h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol

  T=0 to T=6h

• Total Pain Relief (TOTPAR) at 8h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol

  From T=0 to T=8h

• Total Pain Relief (TOTPAR) at 6h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo

  From T=0 to T=6h

• Total Pain Relief (TOTPAR) at 8h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo

  Form T=0 to T=8h

Study Arms (4)

Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg treatment

ACTIVE COMPARATOR

Two phase intervention. Single Dose Phase (time 0 - time 8h) and Multiple Dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet)

Drug: Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg

Tramadol Hydrochloride 100 mg treatment

ACTIVE COMPARATOR

Two phase intervention. Single Dose Phase (time 0 - time 8h) and Multiple Dose Phase (time 8h - Day 5) In this arm patients will receive during each phase (administered as 2 capsules of Tramadol 50 mg)

Drug: Tramadol Hydrochloride 100 mg

Placebo and Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg treatment

PLACEBO COMPARATOR

Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple Dose Phase (time 8h - Day 5). SINGLE DOSE PHASE: Placebo film-coated tablets matching Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg MULTIPLE DOSE PHASE: Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg film coated tablets (administered as one tablet)

Drug: Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg; Drug: Placebo

Placebo and Tramadol Hydrochloride 100 mg

PLACEBO COMPARATOR

Two phase intervention. Single Dose Phase (time 0 - time 8h) and Multiple Dose Phase (time 8h - Day 5). SINGLE DOSE PHASE: Placebo capsules matching active comparator (administered as 2 capsules of Tramadol 50 mg) MULTIPLE DOSE PHASE: Tramadol Hydrochloride 100 mg (administered as 2 capsules of Tramadol 50 mg)

Drug: Tramadol Hydrochloride 100 mg; Drug: Placebo

Interventions

Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg DRUG

Administered as one single tablet to be taken every 8 hours

Also known as: Skudexa

Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg treatment; Placebo and Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg treatment

Tramadol Hydrochloride 100 mg DRUG

Administered as two capsules with 50 mg each to be taken every 8 hours

Also known as: Tramadol

Placebo and Tramadol Hydrochloride 100 mg; Tramadol Hydrochloride 100 mg treatment

Placebo DRUG

Administered as one tablet if matching Dexketoprofen Trometamol 25 mg and Tramadol Hydrochloride 75 mg or two capsules if matching Tramadol Hydrochloride 100 mg

Placebo and Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg treatment; Placebo and Tramadol Hydrochloride 100 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Properly executed written informed consent.
• Male or female patients aged 18 years to 65 years.
• 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.
• Patients with or without radiculopathy will be included, excluding those with neurological signs, according to the Quebec Task Force classification.
• 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.
• Females participating in the study must be either:
• Females of non childbearing potential, defined as any woman who had undergone surgical sterilization (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or is more than 2 years post menopausal (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.
• Mentally competent and able to understand and give written informed consent prior to Screening.
• Compliant to undergo all visits and procedures scheduled in the Study.

You may not qualify if:

• Patients who are judged by the Investigator not to be suitable candidates for the study treatments and the Rescue Medication (RM) based on their medical history, physical examination, Concomitant Medication (CM) and concurrent systemic diseases.
• Clinically significant abnormalities in the vital signs as per Investigator's judgment.
• 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.
• History of hypersensitivity to the study treatments, RM or to any other nonsteroidal anti-inflammatory drugs (NSAIDs), or opioids.
• Known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates.
• History of peptic ulcer, gastrointestinal disorders when taking NSAIDs, gastrointestinal bleeding, or other active bleeding.
• 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.
• Anamnestic mild to severe renal dysfunction, mild to severe hepatic dysfunction, as per Investigator's judgment.
• Patients with chronic dyspepsia.
• Patients with severe heart failure \[Class III and Class IV of New York Heart Association (NYHA) Classification\].
• History of hemorrhagic diathesis and other coagulation disorders.
• History of or current epilepsy or convulsions.
• Patients with Crohn's disease or ulcerative colitis.
• Patients receiving monoamine oxidase (MAO) inhibitors (a minimum of 14 days of washout must elapse prior to the Screening).
• Treatment with topical preparations/medications within 4 hours prior to Screening, anesthetics and muscle relaxants within 8 hours prior to Screening, short-acting analgesics (eg, paracetamol) within 4 hours prior to Screening, other analgesics within 5 half-lives prior to Screening or use of an opioid within the 14 days preceding Screening.

Sponsors & Collaborators

• Menarini International Operations Luxembourg SA: lead

Study Sites (1)

University of L'Aquila

L’Aquila, 67100, Italy

Location

Related Publications (1)

• Varrassi G, Hanna M, Coaccioli S, Fabrizzi P, Baldini S, Kruljac I, Brotons C, Perrot S. Dexketoprofen Trometamol and Tramadol Hydrochloride Fixed-Dose Combination in Moderate to Severe Acute Low Back Pain: A Phase IV, Randomized, Parallel Group, Placebo, Active-Controlled Study (DANTE). Pain Ther. 2024 Aug;13(4):1007-1022. doi: 10.1007/s40122-024-00623-4. Epub 2024 Jun 26.

  PMID: 38922520 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

dexketoprofen trometamol; Tramadol; tramadol, dexketoprofen drug combination

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Limitations and Caveats

No Limitations and Caveats

Results Point of Contact

• Title: Corporate Medical Affair and Clinical Operation Director
• Organization: A Menarini Industrie Farmaceutiche Riunite SrL

pfabrizzi@menarini.it

+39 055 5680459

Study Officials

• Giustino Varrassi, Professor

  University of L'Aquila

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 study phases: a single-dose phase (first 8 hours) and a multiple-dose phase starting after the single-dose phase (from 8h until Day 5).In the single-dose phase the patients will receive a single dose treatment, consisting of 1 film-coated tablet and 2 capsules which must be orally administered together at the same time (Day 1). The multiple-dose phase will begin 8 hours after the first dose. The patients assigned to Dexketoprofen/Tramadol fixed combination or Tramadol 100 mg during the single-dose phase will continue to receive the same treatment during the multiple-dose phase; however, the patients assigned to receive placebo during the single-dose phase will either receive Dexketoprofen/Tramadol fixed combination or Tramadol 100 mg during the multiple-dose phase.

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 28, 2021
• Study Start: September 17, 2020
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)