Back to resultsMentholated Cream Containing Oxygenated Glycerol Triesters on Acute Pain of the Muscles and Joints
Primary Purpose
Pain, Analgesics
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Mentholated Cream
Mentholated Cream with OGT
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Acute Pain, Musculoskeletal Pain, Topical Analgesic
Eligibility Criteria
Inclusion Criteria:
- Were males and females between the ages of 18 and 75, in good general health (no physical required but subjects did fill out a medical history questionnaire)
- Were individuals free of any systemic or dermatological disorder including a known history of allergies or other medical conditions which, in the opinion of the investigator, might have interfered with the conduct of the study, interpretation of results or increased the risk of adverse reactions;
- Were individuals that had recently (< three months) started to suffer from acute musculoskeletal pain (i.e. arthritis, simple back pain, muscle strains);
- Agreed to stop any anti-inflammatory or analgesic medications two days prior to starting the study;
- Had the ability to complete the course of the study and to comply with instructions;
- Agreed not to use or introduce any new personal care products (including cosmetics, skin care, hand care, body care, hair care, personal hygiene, etc.) into their normal regimen during the course of the study;
- Agreed to avoid sun exposure during the course of the study;
- Were females that were surgically sterile, post-menopausal or using an acceptable method of birth control; and
- Were able to read, understand and provide written informed consent.
Exclusion Criteria:
- Were individuals with any visible skin disease or skin condition (e.g., eczema), which might have interfered with the evaluations;
- Were individuals with excessive dryness or redness at the sites of application;
- Were individuals who suffered from chronic and/or severe musculoskeletal pain;
- Were individuals with a known hypersensitivity to topical analgesics or other pain relieving products;
- Were females who were pregnant, planning a pregnancy or nursing a child;
- Were individuals who were participating, or had participated, on a clinical study involving the body (exclusive of the face) within 28 days prior to study initiation;
- Were individuals who had psoriasis;
- Were individuals currently under treatment for asthma or diabetes (insulin-dependent only);
- Were individuals with active atopic dermatitis/eczema at the test sites;
- Were individuals taking prescription or over-the-counter anti-inflammatory medications, non- steroidal anti-inflammatory drugs and topical, oral and systemic steroids; and
- Were individuals with known allergies to any of the components of the test articles.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Mentholated Cream
Mentholated Cream with OGT
Arm Description
Outcomes
Primary Outcome Measures
Severity of Pain
Patients were instructed to identify one area on their body where they were experiencing the most acute musculoskeletal pain/discomfort.
Secondary Outcome Measures
Limitation of Activity
How limited patient activities were due to the pain associated with the area of interest.
Evaluation of the mobility of the painful joint/muscle
Patient assessed how mobile their joints/muscles were within the area of interest.
Skin Toxicity
Tolerability was assessed from Redness and Dryness VAS recorded by the clinical evaluator. No formal safety testing was performed in this study; however anecdotal information (stinging, burning, itching, etc.) was captured on the subjects' diaries.
Full Information
NCT ID
NCT01387750
First Posted
June 30, 2011
Last Updated
July 5, 2011
Sponsor
NEMA Research, Inc.
Collaborators
Laboratories Carilene
1. Study Identification
Unique Protocol Identification Number
NCT01387750
Brief Title
Mentholated Cream Containing Oxygenated Glycerol Triesters on Acute Pain of the Muscles and Joints
Official Title
Evaluating the Efficacy, Tolerance and Acceptability of a Mentholated Cream Containing Oxygenated Glycerol Triesters (OGT) on Acute Pain in Subjects Suffering From a Recent Inflammation of the Muscles and/or Joints
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
NEMA Research, Inc.
Collaborators
Laboratories Carilene
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A single center trial to evaluate the efficacy, tolerance, and acceptability of Oxygenated Glycerol Triesters (OGT) mentholated cream on acute musculoskeletal pain in normal healthy adult volunteers suffering from a recent inflammation of muscles and joints. Patient who met eligibility requirements were instructed to identify one area on their body where they were experiencing the most acute musculoskeletal pain/discomfort. Patients were provided with visual analog scales in order to quantify their pain. Patients either received mentholated cream with or without OGT and instructed to rub on the identified site 3 times a day for 7 days. Pain and other observations were written in a diary for each day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Analgesics
Keywords
Acute Pain, Musculoskeletal Pain, Topical Analgesic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mentholated Cream
Arm Type
Placebo Comparator
Arm Title
Mentholated Cream with OGT
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Mentholated Cream
Intervention Description
A topical cream containing menthol without the addition of the oxygenated glycerol triesters.
Intervention Type
Other
Intervention Name(s)
Mentholated Cream with OGT
Intervention Description
A Topical Cream that contained both menthol and oxygenated glycerol triesters.
Primary Outcome Measure Information:
Title
Severity of Pain
Description
Patients were instructed to identify one area on their body where they were experiencing the most acute musculoskeletal pain/discomfort.
Secondary Outcome Measure Information:
Title
Limitation of Activity
Description
How limited patient activities were due to the pain associated with the area of interest.
Title
Evaluation of the mobility of the painful joint/muscle
Description
Patient assessed how mobile their joints/muscles were within the area of interest.
Title
Skin Toxicity
Description
Tolerability was assessed from Redness and Dryness VAS recorded by the clinical evaluator. No formal safety testing was performed in this study; however anecdotal information (stinging, burning, itching, etc.) was captured on the subjects' diaries.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Were males and females between the ages of 18 and 75, in good general health (no physical required but subjects did fill out a medical history questionnaire)
Were individuals free of any systemic or dermatological disorder including a known history of allergies or other medical conditions which, in the opinion of the investigator, might have interfered with the conduct of the study, interpretation of results or increased the risk of adverse reactions;
Were individuals that had recently (< three months) started to suffer from acute musculoskeletal pain (i.e. arthritis, simple back pain, muscle strains);
Agreed to stop any anti-inflammatory or analgesic medications two days prior to starting the study;
Had the ability to complete the course of the study and to comply with instructions;
Agreed not to use or introduce any new personal care products (including cosmetics, skin care, hand care, body care, hair care, personal hygiene, etc.) into their normal regimen during the course of the study;
Agreed to avoid sun exposure during the course of the study;
Were females that were surgically sterile, post-menopausal or using an acceptable method of birth control; and
Were able to read, understand and provide written informed consent.
Exclusion Criteria:
Were individuals with any visible skin disease or skin condition (e.g., eczema), which might have interfered with the evaluations;
Were individuals with excessive dryness or redness at the sites of application;
Were individuals who suffered from chronic and/or severe musculoskeletal pain;
Were individuals with a known hypersensitivity to topical analgesics or other pain relieving products;
Were females who were pregnant, planning a pregnancy or nursing a child;
Were individuals who were participating, or had participated, on a clinical study involving the body (exclusive of the face) within 28 days prior to study initiation;
Were individuals who had psoriasis;
Were individuals currently under treatment for asthma or diabetes (insulin-dependent only);
Were individuals with active atopic dermatitis/eczema at the test sites;
Were individuals taking prescription or over-the-counter anti-inflammatory medications, non- steroidal anti-inflammatory drugs and topical, oral and systemic steroids; and
Were individuals with known allergies to any of the components of the test articles.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry T Reece, MS, MBA
Organizational Affiliation
RCTS, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jessica Williams, BS
Organizational Affiliation
RCTS, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Mentholated Cream Containing Oxygenated Glycerol Triesters on Acute Pain of the Muscles and Joints
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