Clinical trial NCT01387750: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pain
Analgesics
Keywords: Acute Pain
Musculoskeletal Pain
Topical Analgesic
Lead sponsor: NEMA Research, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Laboratories Carilene
First posted: 2011-07-06
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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)
2. 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;
3. Were individuals that had recently (\< three months) started to suffer from acute musculoskeletal pain (i.e. arthritis, simple back pain, muscle strains);
4. Agreed to stop any anti-inflammatory or analgesic medications two days prior to starting the study;
5. Had the ability to complete the course of the study and to comply with instructions;
6. 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;
7. Agreed to avoid sun exposure during the course of the study;
8. Were females that were surgically sterile, post-menopausal or using an acceptable method of birth control; and
9. Were able to read, understand and provide written informed consent.

Exclusion Criteria:

1. Were individuals with any visible skin disease or skin condition (e.g., eczema), which might have interfered with the evaluations;
2. Were individuals with excessive dryness or redness at the sites of application;
3. Were individuals who suffered from chronic and/or severe musculoskeletal pain;
4. Were individuals with a known hypersensitivity to topical analgesics or other pain relieving products;
5. Were females who were pregnant, planning a pregnancy or nursing a child;
6. 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;
7. Were individuals who had psoriasis;
8. Were individuals currently under treatment for asthma or diabetes (insulin-dependent only);
9. Were individuals with active atopic dermatitis/eczema at the test sites;
10. Were individuals taking prescription or over-the-counter anti-inflammatory medications, non- steroidal anti-inflammatory drugs and topical, oral and systemic steroids; and
11. Were individuals with known allergies to any of the components of the test articles.

Primary outcomes:
measure: Severity of Pain
Secondary outcomes:
measure: Limitation of Activity
measure: Evaluation of the mobility of the painful joint/muscle
measure: Skin Toxicity
Other outcomes:
Locations:
Study officials:
affiliation: RCTS, Inc.
name: Barry T Reece, MS, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: RCTS, Inc.
name: Jessica Williams, BS
role: STUDY_DIRECTOR
References: