Clinical Trials List
Protocol NumberUTX-HP-001
2021-10-16 - 2022-10-15
Phase III
Recruiting4
ICD-10M54.5
Low back pain
ICD-9724.2
Lumbago
A Randomized, Double-blind, Placebo-controlled Phase III Trial to Evaluate the Efficacy, Safety, and Tolerability of Uni-TongXin Topical Herbal Patch in Patients with Acute Back Pain
-
Trial Applicant
Uni-TongXin Biotech Co., Ltd.
-
Sponsor
Uni-TongXin Biotech Co., Ltd.
-
Trial scale
Taiwan Multiple Center
-
Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Low back Pain
Objectives
The objective of this study is to assess the efficacy, safety, and tolerability of Uni-TongXin Topical
Herbal Patch in reducing acute back pain over 7 days of clinical application (study period: 8 days) with
370 subjects.
Test Drug
Uni-TongXin Topical Herbal Patch
Active Ingredient
Dosage Form
Herbal Patch
Dosage
112 mg
Endpoints
Primary Endpoint
(1) Difference in mean change of NRS (numeric rating scale) score on Day 8 between study cohorts.
(Time Frame: From baseline to Day 8)
Secondary Endpoints
(1) Difference in mean change of NRS score on Day 2 and Day 4 between study cohorts. (Time
Frame: From baseline to Day 2 and Day 4)
(2) Difference in proportion of subjects who achieved clinically meaningful pain relief* between study
cohorts during the treatment period. (Time Frame: From baseline to Day 2, Day 4 and Day 8)
*Clinically meaningful pain relief is defined as at least 30% reduction in pain intensity, as
measured by the NRS score.
(3) Difference in WHO Quality of Life-BREF (WHOQOL-BREF, using Taiwan version) between
study cohorts during the treatment period. (Time Frame: From baseline to Day 2, Day 4 and Day
8)
(4) Difference in the frequency of using rescue medication between study cohorts. (Time Frame: From
baseline to Day 8)
(5) Difference in the total dose of rescue medication used between study cohorts during the study.
(Time Frame: From baseline to Day 8)
(6) Adherence of patches to skin during the treatment period.
(7) To compare the mean difference in total score of Oswestry Disability Index between two study
cohorts during the treatment period. (Time Frame: From baseline to Day 2, Day 4 and Day 8)
(8) To compare the mean score of Patient Global Impression of Change (PGIC) between study cohorts
on day 8.
(9) To compare the area under the time-analgesic effect curve for total pain relief (TOTAPR) between
study cohorts. (Time Frame: From baseline to Day 8)
(1) Difference in mean change of NRS (numeric rating scale) score on Day 8 between study cohorts.
(Time Frame: From baseline to Day 8)
Secondary Endpoints
(1) Difference in mean change of NRS score on Day 2 and Day 4 between study cohorts. (Time
Frame: From baseline to Day 2 and Day 4)
(2) Difference in proportion of subjects who achieved clinically meaningful pain relief* between study
cohorts during the treatment period. (Time Frame: From baseline to Day 2, Day 4 and Day 8)
*Clinically meaningful pain relief is defined as at least 30% reduction in pain intensity, as
measured by the NRS score.
(3) Difference in WHO Quality of Life-BREF (WHOQOL-BREF, using Taiwan version) between
study cohorts during the treatment period. (Time Frame: From baseline to Day 2, Day 4 and Day
8)
(4) Difference in the frequency of using rescue medication between study cohorts. (Time Frame: From
baseline to Day 8)
(5) Difference in the total dose of rescue medication used between study cohorts during the study.
(Time Frame: From baseline to Day 8)
(6) Adherence of patches to skin during the treatment period.
(7) To compare the mean difference in total score of Oswestry Disability Index between two study
cohorts during the treatment period. (Time Frame: From baseline to Day 2, Day 4 and Day 8)
(8) To compare the mean score of Patient Global Impression of Change (PGIC) between study cohorts
on day 8.
(9) To compare the area under the time-analgesic effect curve for total pain relief (TOTAPR) between
study cohorts. (Time Frame: From baseline to Day 8)
Inclution Criteria
(1) Male or female patients aged between 20 and 65 years old.
(2) Patients with a diagnosis of acute back pain who meet all of the following conditions:
Onset of symptoms within 14 days prior to the day of screening.
NRS score ≥ 4 on the screening day.
(3) Patients who are willing and able to provide a signed informed consent form (ICF).
(2) Patients with a diagnosis of acute back pain who meet all of the following conditions:
Onset of symptoms within 14 days prior to the day of screening.
NRS score ≥ 4 on the screening day.
(3) Patients who are willing and able to provide a signed informed consent form (ICF).
Exclusion Criteria
(1) Patients with neurologic/neuropsychiatric conditions or cognitive impairments that could interfere
with the correct execution of the sensory tests.
(2) Clinically significant impairment of renal or hepatic function (including BUN, creatinine, AST,
ALT laboratory value ≥ 3 times the upper limit of normal).
(3) Patients with any one of the following abnormalities and/or illnesses:
Significant CNS disorder, including but not limited to head injury, intracranial lesion,
increased intracranial pressure, seizure disorder, stroke within the past 6 months, and disorder
of cognition.
Structural abnormalities in the area being treated.
Open wound or dermatologic disease in the area being treated that might interfere with the
assessment of test site reactions and adherence of the study patch.
Fibromyalgia and chronic fatigue syndrome.
Any underlying condition or disease that is considered not suitable for participation in this
study as determined by the investigator(s).
(4) Patients with a history of hypersensitivity, allergy, or contraindication to any of the components used
in the investigational product.
(5) Patients who used NSAIDs or other analgesic medications within 14 days prior to the day of
screening, with the exception of aspirin taken prophylactically for cardiovascular (CV) reasons.
(6) Patients who received systemic corticosteroids within 28 days prior to the day of screening.
(7) Patients who participated in any other clinical trial within 28 days prior to the day of screening.
(8) Patients with ongoing substance abuse (e.g., drug addiction or alcoholism).
(9) Female patients who are pregnant/lactating or planning to be pregnant or female patients of
childbearing potential*without using medically recognized contraception.
*With the exception of those who have been surgically sterilized (defined as having undergone
hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation alone is not
considered sufficient) or now in menopause for more than 1 year.
with the correct execution of the sensory tests.
(2) Clinically significant impairment of renal or hepatic function (including BUN, creatinine, AST,
ALT laboratory value ≥ 3 times the upper limit of normal).
(3) Patients with any one of the following abnormalities and/or illnesses:
Significant CNS disorder, including but not limited to head injury, intracranial lesion,
increased intracranial pressure, seizure disorder, stroke within the past 6 months, and disorder
of cognition.
Structural abnormalities in the area being treated.
Open wound or dermatologic disease in the area being treated that might interfere with the
assessment of test site reactions and adherence of the study patch.
Fibromyalgia and chronic fatigue syndrome.
Any underlying condition or disease that is considered not suitable for participation in this
study as determined by the investigator(s).
(4) Patients with a history of hypersensitivity, allergy, or contraindication to any of the components used
in the investigational product.
(5) Patients who used NSAIDs or other analgesic medications within 14 days prior to the day of
screening, with the exception of aspirin taken prophylactically for cardiovascular (CV) reasons.
(6) Patients who received systemic corticosteroids within 28 days prior to the day of screening.
(7) Patients who participated in any other clinical trial within 28 days prior to the day of screening.
(8) Patients with ongoing substance abuse (e.g., drug addiction or alcoholism).
(9) Female patients who are pregnant/lactating or planning to be pregnant or female patients of
childbearing potential*without using medically recognized contraception.
*With the exception of those who have been surgically sterilized (defined as having undergone
hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation alone is not
considered sufficient) or now in menopause for more than 1 year.
The Estimated Number of Participants
-
Taiwan
370 participants
-
Global
370 participants
