Trial · NCT01994226
Colchicine Or Naproxen Treatment for ACute gouT
NCT01994226, Phase 4, Completed, Keele University; results first posted 2018-02-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Colchicine Or Naproxen Treatment for ACute gouT. Trials, record NCT01994226. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01994226
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Colchicine Or Naproxen Treatment for ACute gouT
- NCT number
- NCT01994226
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 399 participants, actual
- Lead sponsor
- Keele University
- Conditions
- Gout
- Interventions
- Low-dose colchicine, Naproxen 750 mg/250 mg
- First posted
- 2013-11-25
- Last updated
- 2019-06-18
- Results first posted
- 2018-02-05
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Pain Intensity | Days 0-7 | Worst pain intensity in last 24 hours using a 0 - 10 numeric rating scale, where high rates (10) indicate worst outcome |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Pain Intensity | Days 0-7 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Pain Intensity | Low-dose Colchicine | 3.5 | Standard Deviation 3.1 | units on a scale | |
| Change in Pain Intensity | Naproxen | 3.8 | Standard Deviation 3.2 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low-dose Colchicine | 199 | |
| Overall Study | STARTED | Naproxen | 200 | |
| Overall Study | COMPLETED | Low-dose Colchicine | 180 | |
| Overall Study | COMPLETED | Naproxen | 179 | |
| Overall Study | NOT COMPLETED | Low-dose Colchicine | 19 | |
| Overall Study | NOT COMPLETED | Naproxen | 21 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Non Cardiac chest pain | General disorders | Low-dose Colchicine | 0 | 199 | 0 |
| serious | Non Cardiac chest pain | General disorders | Naproxen | 1 | 200 | 1 |
| serious | Osteomyelitis | Infections and infestations | Low-dose Colchicine | 1 | 199 | 1 |
| serious | Osteomyelitis | Infections and infestations | Naproxen | 0 | 200 | 0 |
| serious | Complication of TAVI procedure | Infections and infestations | Low-dose Colchicine | 0 | 199 | 0 |
| serious | Complication of TAVI procedure | Infections and infestations | Naproxen | 1 | 200 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low-dose Colchicine | 0 | 199 |
| Total, all-cause mortality | Naproxen | 0 | 200 |
| Total, other adverse events | Low-dose Colchicine | 0 | 199 |
| Total, other adverse events | Naproxen | 0 | 200 |
| Total, serious adverse events | Low-dose Colchicine | 1 | 199 |
| Total, serious adverse events | Naproxen | 2 | 200 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Low-dose Colchicine vs Naproxen: deaths from any cause | Trial comparisons |
| Low-dose Colchicine vs Naproxen: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01994226
GET https://conductscience.org/api/trials/v1/NCT01994226/registered