CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
Diclofenac and Atropine combination drug +1 moredrug
Likely dose
Diclofenac and Atropine combination drug 1.2mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02194088
NCT02194088Phase 3Completed

Potential for Improved Analgesia From Combined Medication for Superficial Pain

Brigham and Women's Hospital·interventional·Posted Jul 18, 2014·Updated Jul 3, 2018

In Brief

A Phase 3 clinical trial evaluating Diclofenac and Atropine combination drug and Placebo for Pain. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 18, 2014
Enrollment StartApr 1, 2014
Primary CompletionNov 1, 2014
Study CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.0 years ago

Interventions

Diclofenac and Atropine combination drugdrug

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

Placebodrug

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