Trial Outcomes & Findings for Combined Medication for Improved Analgesia in Superficial Pain (NCT NCT02194088)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

baseline and 1 hour pain measurement

Results posted on

2018-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	75	25
Overall Study COMPLETED	75	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combined Medication for Improved Analgesia in Superficial Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pain Medication: Diclofenac and Atropine n=75 Participants 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	Placebo n=25 Participants 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.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=5 Participants	25 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	24.04 years STANDARD_DEVIATION 4.75 • n=5 Participants	23.16 years STANDARD_DEVIATION 3.94 • n=7 Participants	23.82 years STANDARD_DEVIATION 4.56 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	14 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	11 Participants n=7 Participants	49 Participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants	25 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Pain Medication: Diclofenac and Atropine n=75 Participants 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	Placebo n=25 Participants 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.
Pain Scores on Standardized Experimental Pain Testing Baseline	59.6 units on a scale Standard Deviation 13.9	54.0 units on a scale Standard Deviation 13.9
Pain Scores on Standardized Experimental Pain Testing 1 hour Assessment	44.1 units on a scale Standard Deviation 22.7	45.3 units on a scale Standard Deviation 18.0

SECONDARY outcome

Timeframe: baseline and 1 hour pain measurement

Population: Data were not collected

Difference in the baseline pain measurements compared to the 1-hour outcome measure will be correlated with Catechol-O-methyltransferase polymorphism

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 1 hour pain measurement

Population: 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

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)

Outcome measures

Outcome measures
Measure	Pain Medication: Diclofenac and Atropine n=75 Participants 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	Placebo n=25 Participants 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.
Side Effects Dry mouth	28 Participants	7 Participants
Side Effects Other Side Effects	4 Participants	2 Participants
Side Effects No side effects	43 Participants	16 Participants

Adverse Events

Pain Medication: Diclofenac and Atropine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Edwards Robert

Brigham and Women's Hospital

Phone: 617-732-9486

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place