PainPhase 1/2NCT01387750
Mentholated Cream Containing Oxygenated Glycerol Triesters on Acute Pain of the Muscles and Joints
A Phase 1/2 study testing Mentholated Cream and Mentholated Cream with OGT in people with Pain and Analgesics, run by NEMA Research, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Analgesics
- What is being tested?
- Mentholated Cream and Mentholated Cream with OGT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Jun 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
About this study
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
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
- Being tested
- Mentholated Cream, Mentholated Cream with OGT
- Keywords
- Acute Pain, Musculoskeletal Pain, Topical Analgesic
- Medical subject headings
- Pain, Acute Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentholated CreamOther
A topical cream containing menthol without the addition of the oxygenated glycerol triesters.
Mentholated Cream with OGTOther
A Topical Cream that contained both menthol and oxygenated glycerol triesters.
| Study group | Role | What they receive |
|---|---|---|
| Mentholated Cream | Placebo comparator | Not described Receives: Other: Mentholated Cream |
| Mentholated Cream with OGT | Active comparator | Not described Receives: Other: Mentholated Cream with OGT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startMay 2007
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- NEMA Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratories Carilene
- Investigators
- Barry T Reece, MS, MBA, Principal investigator, RCTS, Inc.Jessica Williams, BS, Study director, RCTS, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387750
- Sponsor's protocol ID
- RCTS2223
- Status last verified
- Jun 2011
- First submitted
- 30 Jun 2011
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01387750
- Acronym / sponsor ID
- RCTS2223
- Conditions
- Pain, Analgesics
- Keywords
- Acute Pain, Musculoskeletal Pain, Topical Analgesic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- NEMA Research, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Laboratories Carilene
- Study start
- May 2007
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mentholated Cream | Placebo comparator | Other: Mentholated Cream |
| Mentholated Cream with OGT | Active comparator | Other: Mentholated Cream with OGT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentholated CreamA topical cream containing menthol without the addition of the oxygenated glycerol triesters. | Other | Mentholated Cream |
| Mentholated Cream with OGTA Topical Cream that contained both menthol and oxygenated glycerol triesters. | Other | Mentholated Cream with OGT |
Primary outcome
Severity of Pain
Patients were instructed to identify one area on their body where they were experiencing the most acute musculoskeletal pain/discomfort.
3 secondary outcomes
Limitation of Activity
Evaluation of the mobility of the painful joint/muscle
Skin Toxicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry T Reece, MS, MBA principal investigator
RCTS, Inc.
Jessica Williams, BS study director
RCTS, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mentholated Cream and Mentholated Cream with OGT in people with Pain and Analgesics, run by NEMA Research, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Pain. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2011.