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NCT Number: NCT02194088

Combined Medication for Improved Analgesia in 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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brigham And Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Diclofenac and Atropine combination drug

Drug

Diclofenac will be associated with a small dose of atropine 1.2mg

Other names: Analgesic drug, Combination drug, Test drug, Diclofenac and atropine, Atropine and diclofenac

Placebo

Drug

For each capsule of active medication, a capsule of placebo will be provided, identical looking.

Other names: Placebo control for the active medication

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. Side Effects

    Time frame: baseline and 1 hour pain measurement

    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)

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Beth Israel Deaconess Medical Center

Registry information

Official study title

Potential for Improved Analgesia From Combined Medication for Superficial Pain

Important dates

Study start
2014
Primary completion
2014
Study completion
2017
First posted
Jul 18, 2014
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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