Combined Medication for Improved Analgesia in Superficial Pain

Pain Clinical Trial

Official title:

Potential for Improved Analgesia From Combined Medication for Superficial Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194088
• Other study ID #: 2013P001857
• Status: Completed
• Phase: Phase 3
• Start date: April 2014
• Est. completion date: June 2017

Study information

• Verified date: June 2018
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2017
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Diclofenac and Atropine combination drug
Diclofenac will be associated with a small dose of atropine 1.2mg
• Placebo
For each capsule of active medication, a capsule of placebo will be provided, identical looking.

Locations

Country	Name	City	State
United States	Brigham And Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Berna C, Kirsch I, Zion SR, Lee YC, Jensen KB, Sadler P, Kaptchuk TJ, Edwards RR. Side effects can enhance treatment response through expectancy effects: an experimental analgesic randomized controlled trial. Pain. 2017 Jun;158(6):1014-1020. doi: 10.1097/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores on Standardized Experimental Pain Testing	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	Catechol-O-methyltransferase (COMT) Polymorphism Correlation With Pain Relief	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
Secondary	Side Effects	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