---
title: Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
nct_id: NCT01471886
overall_status: COMPLETED
phase: PHASE3
sponsor: EMS
study_type: INTERVENTIONAL
primary_condition: Back Pain
countries: Brazil
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01471886.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01471886"
ct_last_update_post_date: 2021-02-24
last_seen_at: "2026-05-12T07:04:29.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment

**Official Title:** Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment

**NCT ID:** [NCT01471886](https://clinicaltrials.gov/study/NCT01471886)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 83
- **Lead Sponsor:** EMS
- **Conditions:** Back Pain
- **Start Date:** 2013-03
- **Completion Date:** 2013-11-11
- **CT.gov Last Update:** 2021-02-24

## Brief Summary

The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of two different drugs in the treatment of patients diagnosed with moderate to severe back pain.

## Detailed Description

* double-blind, double-dummy, non-inferiority, prospective, parallel group, intent to treat trial.
* Experiment duration: 04 days.
* 03 visits (days 0, 2 and 4).
* Efficacy will be evaluated for back pain relief based on visual analog scale.
* Adverse events evaluation.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Consent of the patient or legal guardian.
* Men or women aged between 18 and 65.
* Diagnosis of acute low back pain with moderate to severe pain (Visual Analog Scale greater than 4 cm)

Exclusion Criteria:

* fracture confirmed by X-ray
* Diagnosis of infection, fever,
* Pregnancy, lactation;
* Diagnosis of fibromyalgia;
* Hypersensitivity to ketorolac tromethamine, any of the ingredients of the formula or other Nonsteroidal anti-inflammatory
```

## Arms

- **Naproxen** (ACTIVE_COMPARATOR) — Every 8 hours for 4 days.
- **Ketorolac Tromethamine** (EXPERIMENTAL) — Every 8 hours for 4 days

## Interventions

- **Ketorolac Tromethamine** (DRUG) — Every 8 hours for 4 days.
- **Naproxen** (DRUG) — Every 8 hours for 4 days.

## Primary Outcomes

- **Efficacy of treatment in back pain relief based on Visual Analog Scale (VAS).** _(time frame: 4 days)_ — The individual response rate to the relieve of pain is calculated by measuring VAS during the first and last visit.

The response rate is calculated using the following formula:

Response rate = (VASvi - VASvf) / VASvi

Considering:

* VASvi: VAS in the first visit;
* VASvf: VAS at the last visit;

## Secondary Outcomes

- **Safety will be evaluated by the adverse events occurrences** _(time frame: day 4)_

## Locations (1)

- IOT - Instituto de Ortopedia e Traumatologia, São Paulo, São Paulo, Brazil

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.iot - instituto de ortopedia e traumatologia|são paulo|são paulo|brazil` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01471886.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01471886*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*