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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| placebo | Placebo Comparator | Placebo capsules will be delivered in same number as the medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac and Atropine combination drug | Drug | Diclofenac will be associated with a small dose of atropine 1.2mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Side Effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert R Edwards, PHD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham And Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28178072 | Result | 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. | |
| 36877132 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg |
| FG001 | Placebo | Placebo capsules will be delivered in same number as the medication Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | units on a scale | baseline and 1 hour pain measurement |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edwards Robert | Brigham and Women's Hospital | 617-732-9486 | rredwards@partners.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D000082 | Acetaminophen |
| D004338 | Drug Combinations |
| D004341 | Drug Evaluation |
| D001285 | Atropine |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | For each capsule of active medication, a capsule of placebo will be provided, identical looking. |
|
|
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 |
| Placebo |
Placebo capsules will be delivered in same number as the medication Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | Data were not collected | Posted | 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) | Participants were analyzed in terms of whether they endorsed or not the side effects (yes/no) Participants were not analyzed in terms of severity degree | Posted | Count of Participants | Participants | baseline and 1 hour pain measurement |
|
|
|
| 0 |
| 75 |
| 0 |
| 75 |
| 0 |
| 75 |
| EG001 | Placebo | Placebo capsules will be delivered in same number as the medication Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004364 | Pharmaceutical Preparations |
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| No side effects |
|