Placebo Controlled Clinical Study to Evaluate the Relief of Acute Muscular Pain with the use of a Cream, a Traditional Herbal Medicinal Product.

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2017-000765-78-SI
• Date of registration: 14/06/2017
• Prospective Registration: Yes
• Primary sponsor: Medis, d.o.o.
• Public title: Placebo Controlled Clinical Study to Evaluate the Relief of Acute Muscular Pain with the use of a Cream, a Traditional Herbal Medicinal Product.
• Scientific title: Randomized, Double-blind, Placebo Controlled Clinical Study To Evaluate Analgesic Efficacy of Topically Administered Traditional Herbal Medicinal Product for Relief of Acute Muscular Pain. - ROSE-01
• Date of first enrolment: 18/07/2017
• Target sample size: 148
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-000765-78
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Slovenia

Contacts

• Name: Head Regulatory Affairs Development
• Affiliation: Medis, d.o.o.

• Name: Head Regulatory Affairs Development
• Affiliation: Medis, d.o.o.

Key inclusion & exclusion criteria

Inclusion criteria:
• Male and female
• 30-65 years
• Acute muscular pain
• Pain strength 4-6 according to NRS

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 148
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Chronic pain
• Chronic use of analgetics
• Suspicion of injury
• Known allergies



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Not possible to specify

Acute Muscular Pain

Intervention(s)

Trade Name: Rosacta krema
Product Name: Rosacta krema
Pharmaceutical Form: Cream
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Cutaneous use

Primary Outcome(s)

Secondary Objective: n.a.

Timepoint(s) of evaluation of this end point: After 7 days of treatment

Main Objective: The proportion of subjects with clinically significant decrease in pain intensity (?NRS = 2 points) after 7 days in a test group in comparison to the group receiving placebo.

Primary end point(s): The proportion of subjects with clinically significant decrease in pain intensity (?NRS = 2 points) after 7 days in the test group compared to the group receiving placebo.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: The proportion of subjects with clinically significant decrease in pain intensity (?NRS = 2 points), Decrease in pain intensity, The proportion of subjects with decrease in pain intensity for 33% of NRS, - will be evaluated after 4 days of treatment

Decrease in pain intensity, The proportion of subjects with decrease in pain intensity for 33% of NRS, amount of intake of rescue medication, incidence of adverse events, incidence of serious adverse events, Quality of Life improvement - will be evaluated after 7 days of treatment

Secondary end point(s): • The proportion of subjects with clinically significant decrease in pain intensity (?NRS = 2 points) after 4 days in a test group in comparison to the group receiving placebo.
• Decrease in pain intensity (NRS) after 7 days from baseline in a test group in comparison to the group receiving placebo.
• Decrease in pain intensity (NRS) after 4 days from baseline in a test group in comparison to the group receiving placebo.
• The proportion of subjects with the decrease in pain intensity for 33% of NRS points after 7 days in a test group in comparison to the group receiving placebo.
• The proportion of subjects with the decrease in pain intensity for 33% of NRS points after 4 days in a test group in comparison to the group receiving placebo.
• The amount of intake of rescue medication in a test group in comparison to the group receiving placebo, for 7 days of the study duration.
• The incidence of adverse events in a test group in comparison to the group receiving placebo, for 7 days of the study duration.
• The incidence of serious adverse events in a test group in comparison to the group receiving placebo, for 7 days of the study duration
• Quality of Life improvement (SF-36v2 with PIQ-6, acute recall)

Secondary ID(s)

ROSE-01

Source(s) of Monetary Support

Medis., d.o.o.

Ethics review

Status: Approved
Approval date:
Contact: