- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02194088
Combined Medication for Improved Analgesia in Superficial Pain
June 4, 2018 updated by: Robert Edwards, Brigham and Women's Hospital
Potential for Improved Analgesia From Combined Medication for Superficial Pain
This research study is being done to assess if a combination of medications can enhance the relief of superficial pain (pain at the surface of the skin, such as sunburn pain).
The investigators also want to find out if certain genes may be linked to individual differences in experienced efficacy of pain killers.
The combination of medications under investigation is diclofenac and atropine.
Diclofenac has been approved by the U.S. Food and Drug Administration (FDA) to treat pain.
Atropine has been approved by the FDA to treat certain types of poisoning, heartbeat problems, and other diseases but atropine is not approved to treat pain.
However, atropine has been used for many years in different European countries to treat painful conditions such as stomach cramps.This research study will compare diclofenac and atropine to placebo.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female healthy volunteers.
- 18-40 years of age.
- Ability to read and understand English; English can be a second language provided that the participant feels that he/she understand all the questions used in the assessment measures.
Exclusion Criteria:
- Chronic pain condition or chronic or current treatment with any pain medication.
- Presence of any illness or medication use that is judged to interfere with the trial. For example: psychiatric disorder, medication that can influence cognition or emotional processing, i.e. sleep medication, antidepressants, anti-convulsants or opioids.
- Unwillingness to receive brief pain stimulation administered by a heat probe on the hand.
- Allergy or contra-indication to receiving nonsteroidal anti-inflammatory medication and atropine (Treatment with antidepressants, neuroleptics, antihistaminic, levodopa, anti-acids. Pregnancy, breast-feeding, myasthenia gravis, pyloric stenosis, gastro-esophageal reflux, gastric ulcer, constipation, prostatic enlargement, glaucoma, cardio-pulmonary condition -including tachycardia, arrhythmia, arteriosclerosis-, hyperthyroidism, high blood pressure, genetic disease, kidney failure)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pain medication: diclofenac and atropine
Diclofenac and Atropine combination drug Provided PO.
This is a novel combination.
Diclofenac 100mg + Atropine 1.2 mg in one single dose
|
Diclofenac will be associated with a small dose of atropine 1.2mg
Other Names:
|
Placebo Comparator: placebo
Placebo capsules will be delivered in same number as the medication
|
For each capsule of active medication, a capsule of placebo will be provided, identical looking.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Scores on Standardized Experimental Pain Testing
Time Frame: baseline and 1 hour pain measurement
|
Pain scores on standardized experimental pain testing, with collection of Visual analog scales (VAS) on a 0-100 scale 0 (no pain)- 100 (worst pain imaginable) Higher values represent a worse outcome (more pain)
|
baseline and 1 hour pain measurement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Catechol-O-methyltransferase (COMT) Polymorphism Correlation With Pain Relief
Time Frame: baseline and 1 hour pain measurement
|
Difference in the baseline pain measurements compared to the 1-hour outcome measure will be correlated with Catechol-O-methyltransferase polymorphism
|
baseline and 1 hour pain measurement
|
Side Effects
Time Frame: baseline and 1 hour pain measurement
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The investigators aimed assess if these would be a reason for discontinuation of treatment in a population with mild to moderate pain.Side effects will be assessed with a dichotomous measurement (yes/no)
|
baseline and 1 hour pain measurement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
December 11, 2013
First Submitted That Met QC Criteria
July 16, 2014
First Posted (Estimate)
July 18, 2014
Study Record Updates
Last Update Posted (Actual)
July 3, 2018
Last Update Submitted That Met QC Criteria
June 4, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Enzyme Inhibitors
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Adjuvants, Anesthesia
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Mydriatics
- Diclofenac
- Atropine
- Analgesics
Other Study ID Numbers
- 2013P001857
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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