IRPATCH: Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain

Sponsor
Sanofi (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05137041
Collaborator
(none)
200
7
2
12.1
28.6
2.4

Study Details

Study Description

Brief Summary

Primary Objective:

To assess the efficacy of the infrared therapy patch (ITP) FIRTECH for treating participants suffering from mild to moderate acute low back pain.

Secondary Objectives:
  • To assess the efficacy of ITP FIRTECH on participant disability

  • To assess the efficacy of ITP FIRTECH on the degree of participant mobility

  • To assess the safety of ITP FIRTECH

Condition or Disease Intervention/Treatment Phase
  • Device: ITP FIRTECH
  • Other: No Patch
Phase 3

Detailed Description

Duration of study participation is up to 6 days per participant.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase IIIB Randomized, Open Label, Two Arms and Parallel Group Clinical Trial to Assess the Efficacy and Safety of FIRTECH (Infrared Therapy Patch), for Treating Patients Suffering From Mild to Moderate Acute Low Back Pain
Actual Study Start Date :
Nov 4, 2021
Anticipated Primary Completion Date :
Nov 7, 2022
Anticipated Study Completion Date :
Nov 7, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: ITP FIRTECH

ITP FIRTECH patch will be applied and remain in position for 5 days

Device: ITP FIRTECH
Infrared Therapy Patch

Other: No Patch Control Arm

No patch application

Other: No Patch
No Intervention

Outcome Measures

Primary Outcome Measures

  1. Percentage of Numerical Rating Scale (NRS) responders at Day 5 [Baseline and Day 5]

    NRS is used to assess pain intensity. Responder is defined as participant with ≥30% decrease from baseline in pain NRS and who did not take rescue medication

Secondary Outcome Measures

  1. Number of participants reported with adverse events [Day 1 to Day 6]

    Number of participants reported with treatment-emergent adverse events (TEAEs)

  2. Normalized Sum of Pain Intensity Difference (PID) over 5 days (SPID0-5) [Baseline up to Day 5]

    PID equals the NRS change from baseline. A negative difference indicates improvement. Time-weighted summed pain intensity difference (SPID) was calculated by multiplying the PID score at each postdose time point by the duration since the preceding time point and then summing these values.

  3. Percentage change in Roland-Morris Disability Questionnaire (RMDQ) score over 5 days [Baseline and Day 5]

    Self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale, with 1 point per question.

  4. Mobility evaluation [Baseline and Day 5]

    Change in mobility from baseline to Day 5 based on descriptive analysis using Schober's test or Fingertip-to-Floor test.

  5. Time to reach acceptable pain [Up to Day 5]

    Time to reach acceptable pain based on a NRS of 0 from baseline to Day 5

  6. Time to reach no pain [Up to Day 5]

    Time to reach no pain based on a NRS of 0 from baseline to Day 5

  7. Time course of PID [Baseline up to Day 5]

    Time points for PID to be defined from baseline to Day 5

  8. Time course of pain relief [Baseline up to Day 5]

    Pain relief is assessed using a verbal rating scale, where 0 = none and 4 = complete in response to a pain relief question

  9. Normalized sum of pain relief [Baseline up to Day 5]

    Summed pain relief score (TOTPAR) calculated by multiplying the pain relief score at each postdose time point by the duration since the preceding time point and then summing these values. Higher scores indicate more pain relief.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Participants suffering from mild to moderate acute low back pain

  • Low back pain (lumbar back pain) is defined as pain in the back from the level of the lowest rib down to the gluteal fold

  • Acute episode is defined as first pain episode in participant's life, or after a pain-free interval of at least six months, and lasts no longer than six weeks -With intensity ≤ 6 on 0-10 Numerical Rating Scale (NRS) - - - -

Exclusion Criteria:
  • Participants suffering from any neurological pathology which could be responsible of the pain

  • Participants suffering from leg pain irradiation

  • Participants suffering from chronic lumbar pain of any etiology

  • Participants with chronic arthrosis and neurological symptoms

  • Participants experiencing recent significant trauma (i.e., injury related to a fall from a height or motor vehicle crash, or from a minor fall or heavy lifting in a participants with osteoporosis or possible osteoporosis)

  • Participants with major or progressive motor or sensory deficit, new-onset bowel or bladder incontinence or urinary retention, loss of anal sphincter tone, saddle anesthesia, history of cancer metastatic to bone, and suspected spinal infection

  • Participants experiencing work litigation, anxiety and/or depression

  • Participants taking any medication for their pain within the last 5 days (only accepted up to 2 g of paracetamol per day)

  • Participants having received any therapy (medication or patches) for their pain within the last 5 days

  • Participants currently using recreational or illicit drugs or with a recent history of drug or alcohol abuse or dependence

  • Participants with any other medical condition that would interfere with efficacy and safety assessments based on investigator's judgment

  • Participants having received non-pharmaceutical lower back pain treatment (physiotherapy, heat treatment or massage) within 12 hours prior to enrollment

  • Participants having received spinal injection back pain treatment within 6 months prior to enrollment

  • Participants having received surgery due to back pain or rehabilitation due to back pain in the last 12 months

  • Participants with a known sensitivity to paracetamol

  • Participants with known cutaneous hypersensitivity to plaster

  • Participants participating in another clinical study within the past 30 days

  • Participants who are pregnant or breastfeeding; contraception is mandatory

  • Participants having damaged, non-intact, or scarred skin in or near the point of patch application

  • Participants having a known skin sensitivity

  • Participants having impaired blood circulation

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Investigational Site Number :06 Bad Homburg Germany 61348
2 Investigational Site Number :02 Leipzig Germany 04103
3 Investigational Site Number :01 Munich Germany 80809
4 Investigational Site Number :03 Weinheim Germany 69469
5 Investigational Site Number :7 Taormina Messina Italy 98039
6 Investigational Site Number :5 Alessandria Italy 15100
7 Investigational Site Number :4 Chieti Italy 66100

Sponsors and Collaborators

  • Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT05137041
Other Study ID Numbers:
  • LPS16453
  • U1111-1255-4648
First Posted:
Nov 30, 2021
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 20, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2022