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

This study has been completed.
Sponsor:
Collaborator:
Laboratories Carilene
Information provided by:
NEMA Research, Inc.
ClinicalTrials.gov Identifier:
NCT01387750
First received: June 30, 2011
Last updated: July 5, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Pain
Analgesics
Other: Mentholated Cream
Other: Mentholated Cream with OGT
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NEMA Research, Inc.:

Primary Outcome Measures:
  • Severity of Pain [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    How limited patient activities were due to the pain associated with the area of interest.

  • Evaluation of the mobility of the painful joint/muscle [ Designated as safety issue: No ]
    Patient assessed how mobile their joints/muscles were within the area of interest.

  • Skin Toxicity [ Designated as safety issue: Yes ]
    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.


Enrollment: 71
Study Start Date: May 2007
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Mentholated Cream Other: Mentholated Cream
A topical cream containing menthol without the addition of the oxygenated glycerol triesters.
Active Comparator: Mentholated Cream with OGT Other: Mentholated Cream with OGT
A Topical Cream that contained both menthol and oxygenated glycerol triesters.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387750

Sponsors and Collaborators
NEMA Research, Inc.
Laboratories Carilene
Investigators
Principal Investigator: Barry T Reece, MS, MBA RCTS Inc.
Study Director: Jessica Williams, BS RCTS Inc.
  More Information

No publications provided

Responsible Party: Barry T. Reece, MS, MBA, Reliance Clinical Trial Services
ClinicalTrials.gov Identifier: NCT01387750     History of Changes
Other Study ID Numbers: RCTS2223
Study First Received: June 30, 2011
Last Updated: July 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by NEMA Research, Inc.:
Acute Pain
Musculoskeletal Pain
Topical Analgesic

Additional relevant MeSH terms:
Acute Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Glycerol
Cryoprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 20, 2014