Combined Medication for Improved Analgesia in Superficial Pain

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Diclofenac and Atropine combination drug

Intervention Type DRUG

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

placebo

Placebo capsules will be delivered in same number as the medication

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Diclofenac and Atropine combination drug

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Analgesic drug Combination drug Test drug Diclofenac and atropine Atropine and diclofenac Placebo control for the active medication

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes