Combined Medication for Improved Analgesia in Superficial Pain

NCT02194088 | Completed Phase 3 Results

• 1 other identifier: 2013P001857
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Catechol-O-methyltransferase (COMT) Polymorphism Correlation With Pain Relief

  baseline and 1 hour pain measurement

• Side Effects

  baseline and 1 hour pain measurement

Study Arms (2)

Pain medication: diclofenac and atropine

EXPERIMENTAL

Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose

Drug: Diclofenac and Atropine combination drug

placebo

PLACEBO COMPARATOR

Placebo capsules will be delivered in same number as the medication

Drug: Placebo

Interventions

Diclofenac and Atropine combination drug DRUG

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

Also known as: Analgesic drug, Combination drug, Test drug, Diclofenac and atropine, Atropine and diclofenac

Pain medication: diclofenac and atropine

Placebo DRUG

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

Also known as: Placebo control for the active medication

placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female healthy volunteers.
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Brigham And Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• 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/j.pain.0000000000000870.

  PMID: 28178072 RESULT

• Laursen DR, Nejstgaard CH, Bjorkedal E, Frost AD, Hansen MR, Paludan-Muller AS, Prosenz J, Werner CP, Hrobjartsson A. Impact of active placebo controls on estimated drug effects in randomised trials: a systematic review of trials with both active placebo and standard placebo. Cochrane Database Syst Rev. 2023 Mar 6;3(3):MR000055. doi: 10.1002/14651858.MR000055.pub2.

  PMID: 36877132 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Diclofenac; Acetaminophen; Drug Combinations; Drug Evaluation; Atropine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Pharmaceutical Preparations; Drug Development; Investigative Techniques; Evaluation Studies as Topic; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Edwards Robert
• Organization: Brigham and Women's Hospital

rredwards@partners.org

617-732-9486

Study Officials

• Robert R Edwards, PHD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: July 18, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: June 1, 2017
• Last Updated: July 3, 2018
• Results First Posted: May 30, 2017

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)