Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain (IRPATCH)
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ITP FIRTECH
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
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 acute pain with less than 1 month duration
- With intensity less than or equal to 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 clinically diagnosed with anxiety and/or depression
- Participants using any medication for their pain within the last 48 hours within enrollment into the study
- Participants taking any systemic medication for their pain within the last 24 hours (48 hours for diclofenac or corticosteroids)
- 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.
Sites / Locations
- Investigational Site Number :06
- Investigational Site Number :02
- Investigational Site Number :01
- Investigational Site Number :03
- Investigational Site Number :7
- Investigational Site Number :5
- Investigational Site Number :4
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ITP FIRTECH
No Patch Control Arm
Arm Description
ITP FIRTECH patch will be applied and remain in position for 5 days
No patch application
Outcomes
Primary Outcome Measures
Percentage of Numerical Rating Scale (NRS) responders at 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
Number of participants reported with adverse events
Number of participants reported with treatment-emergent adverse events (TEAEs)
Normalized Sum of Pain Intensity Difference (PID) over 5 days (SPID0-5)
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.
Percentage change in Roland-Morris Disability Questionnaire (RMDQ) score over 5 days
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.
Mobility evaluation
Change in mobility from baseline to Day 5 based on descriptive analysis using Schober's test or Fingertip-to-Floor test.
Time to reach acceptable pain
Time to reach acceptable pain based on a NRS of 0 from baseline to Day 5
Time to reach no pain
Time to reach no pain based on a NRS of 0 from baseline to Day 5
Time course of PID
Time points for PID to be defined from baseline to Day 5
Time course of pain relief
Pain relief is assessed using a verbal rating scale, where 0 = none and 4 = complete in response to a pain relief question
Normalized sum of pain relief
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05137041
Brief Title
Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain
Acronym
IRPATCH
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 4, 2021 (Actual)
Primary Completion Date
November 22, 2022 (Actual)
Study Completion Date
November 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
Detailed Description
Duration of study participation is up to 6 days per participant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ITP FIRTECH
Arm Type
Experimental
Arm Description
ITP FIRTECH patch will be applied and remain in position for 5 days
Arm Title
No Patch Control Arm
Arm Type
No Intervention
Arm Description
No patch application
Intervention Type
Device
Intervention Name(s)
ITP FIRTECH
Intervention Description
Infrared Therapy Patch
Primary Outcome Measure Information:
Title
Percentage of Numerical Rating Scale (NRS) responders at Day 5
Description
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
Time Frame
Baseline and Day 5
Secondary Outcome Measure Information:
Title
Number of participants reported with adverse events
Description
Number of participants reported with treatment-emergent adverse events (TEAEs)
Time Frame
Day 1 to Day 6
Title
Normalized Sum of Pain Intensity Difference (PID) over 5 days (SPID0-5)
Description
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.
Time Frame
Baseline up to Day 5
Title
Percentage change in Roland-Morris Disability Questionnaire (RMDQ) score over 5 days
Description
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.
Time Frame
Baseline and Day 5
Title
Mobility evaluation
Description
Change in mobility from baseline to Day 5 based on descriptive analysis using Schober's test or Fingertip-to-Floor test.
Time Frame
Baseline and Day 5
Title
Time to reach acceptable pain
Description
Time to reach acceptable pain based on a NRS of 0 from baseline to Day 5
Time Frame
Up to Day 5
Title
Time to reach no pain
Description
Time to reach no pain based on a NRS of 0 from baseline to Day 5
Time Frame
Up to Day 5
Title
Time course of PID
Description
Time points for PID to be defined from baseline to Day 5
Time Frame
Baseline up to Day 5
Title
Time course of pain relief
Description
Pain relief is assessed using a verbal rating scale, where 0 = none and 4 = complete in response to a pain relief question
Time Frame
Baseline up to Day 5
Title
Normalized sum of pain relief
Description
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.
Time Frame
Baseline up to Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 acute pain with less than 1 month duration
With intensity less than or equal to 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 clinically diagnosed with anxiety and/or depression
Participants using any medication for their pain within the last 48 hours within enrollment into the study
Participants taking any systemic medication for their pain within the last 24 hours (48 hours for diclofenac or corticosteroids)
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number :06
City
Bad Homburg
ZIP/Postal Code
61348
Country
Germany
Facility Name
Investigational Site Number :02
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Investigational Site Number :01
City
Munich
ZIP/Postal Code
80809
Country
Germany
Facility Name
Investigational Site Number :03
City
Weinheim
ZIP/Postal Code
69469
Country
Germany
Facility Name
Investigational Site Number :7
City
Taormina
State/Province
Messina
ZIP/Postal Code
98039
Country
Italy
Facility Name
Investigational Site Number :5
City
Alessandria
ZIP/Postal Code
15100
Country
Italy
Facility Name
Investigational Site Number :4
City
Chieti
ZIP/Postal Code
66100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain
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