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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000765-78-SI

Enrollment

148

Registered

2017-06-14

Start date

2017-07-18

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Muscular Pain

Interventions

Trade Name: Rosacta krema Product Name: Rosacta krema Pharmaceutical Form: Cream Pharmaceutical form of the placebo: Cream Route of admi

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.;Secondary Objective: n.a.;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.;Timepoint(s) of evaluation of this end point: After 7 days of treatment	—

Measure

Time frame

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.;Secondary Objective: n.a.;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.;Timepoint(s) of evaluation of this end point: After 7 days of treatment

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Secondary

Measure	Time frame
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) ; 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	—

Measure

Time frame

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) ; 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

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Countries

Slovenia

Contacts

Public ContactHead Regulatory Affairs Development

Medis, d.o.o.

alenka.drazumeric@medis.si38615896952

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026