Mentholated Cream Containing Oxygenated Glycerol Triesters on Acute Pain of the Muscles and Joints

NCT01387750 | Completed Phase 1 DMC

• 1 other identifier: RCTS2223
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain; Analgesics

Keywords

Acute Pain; Musculoskeletal Pain; Topical Analgesic

Outcome Measures

Primary Outcomes (1)

• Severity of Pain

  Patients were instructed to identify one area on their body where they were experiencing the most acute musculoskeletal pain/discomfort.

Secondary Outcomes (3)

• Limitation of Activity

• Evaluation of the mobility of the painful joint/muscle

• Skin Toxicity

Study Arms (2)

Mentholated Cream

PLACEBO COMPARATOR

Other: Mentholated Cream

Mentholated Cream with OGT

ACTIVE COMPARATOR

Other: Mentholated Cream with OGT

Interventions

Mentholated Cream OTHER

A topical cream containing menthol without the addition of the oxygenated glycerol triesters.

Mentholated Cream

Mentholated Cream with OGT OTHER

A Topical Cream that contained both menthol and oxygenated glycerol triesters.

Mentholated Cream with OGT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NEMA Research, Inc.: lead
• Laboratories Carilene: collaborator

MeSH Terms

Conditions

Pain; Acute Pain; Musculoskeletal Pain

Interventions

UDP-N-acetylglucosamine-peptide beta-N-acetylglucosaminyltransferase

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Barry T Reece, MS, MBA

  RCTS, Inc.

  PRINCIPAL INVESTIGATOR

• Jessica Williams, BS

  RCTS, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 6, 2011
• Study Start: May 1, 2007
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: July 6, 2011

Record last verified: 2011-06