Trial · NCT02688400

Effect of Diacerein vs Celecoxib on Symptoms and Structural Changes in Symptomatic Knee Osteoarthritis

NCT02688400, Phase 3, Completed, TRB Chemedica International SA; results first posted 2023-12-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Diacerein vs Celecoxib on Symptoms and Structural Changes in Symptomatic Knee Osteoarthritis. Trials, record NCT02688400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02688400

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of Diacerein vs Celecoxib on Symptoms and Structural Changes in Symptomatic Knee Osteoarthritis
NCT number: NCT02688400
Status: Completed
Phases: Phase 3
Enrollment: 380 participants, actual
Lead sponsor: TRB Chemedica International SA
Conditions: Osteoarthritis, Osteoarthritis, Knee
Interventions: Diacerein, Celecoxib, Placebo
First posted: 2016-02-23
Last updated: 2023-12-01
Other registries' IDs: eudract:2015-002933-23
Results first posted: 2023-12-01

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change Form Baseline in WOMAC A Pain Subscale	baseline and 182 days	Change form baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) A pain subscale after 182 days of treatment. WOMAC A pain subscale: 0 - 50 cm; 50 = worse
Secondary	Change From Baseline in WOMAC OA Scores	Day 182 or early termination	Absolute Changes from Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) after 182 days of treatment. WOMAC scale: 0 - 240 cm; 240 = worse - Intention-To-Treat (N=370) Pain subscale: 0-50cm; 50 = worse; Stifness subscale: 0-20cm; 20 = worse; Function subscale: 0-170cm; 170 = worse Absolute changes in WOMAC scores: \<0 = improvement; 0 = stable; \>0 = worsening
Secondary	Absolute Changes From Baseline in Pain Visual Analogue Scale	Day 182 or early termination	Absolute Changes from Baseline in Pain Visual Analogue Scale (VAS): 0-10 cm; 10 = worse
Secondary	OARSI Responders	Day 182 or early termination	Osteoarthritis Research Society International (OARSI) Responders
Secondary	Assessment of Joint Swelling, Effusion or Both	Day 182 or early termination	Assessment of Joint Swelling, joint Effusion or Both
Secondary	Consumption of Acetaminophen	Day 182 or early termination	Overall Daily number of tablets taken during the 6 month study
Secondary	Change From Baseline in Patient's Global Assessment of Disease Activity	Day 182 or early termination	Change from baseline in global assessment of disease activity was assessed using a VAS scale (0-10cm; 10=worse)
Secondary	Global Assessment of Response to Therapy	Day 182 or early termination	Between group comparison in Patient's and Investigator's Global Assessment of Response to Therapy using a 0-10 cm disease activity VAS scale: 0 cm = very well; 10 cm = very poorly
Secondary	Quality of Life SF-36	Day 182 or early termination	Absolute Changes from Baseline in Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the Quality of Life questionnaire SF-36. Scale range for each component (PCS and MCS): minimum = 0, maximum = 100, with higher scores indicating better quality of life. Absolute changes in each component (PCS and MCS): \>0 = improvement; 0 = stable; \<0 = worsening.
Other	Cartilage Volume Loss From Baseline in the Medial Compartment Using MRI	baseline and 728 days	Relative cartilage volume loss from baseline in the medial compartment of the knee using MRI

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change Form Baseline in WOMAC A Pain Subscale	baseline and 182 days	The Per Protocol Set (PPS) was a subset of the ITT and included all patients who did not present any major deviation of the protocol over the 6-month follow-up period. These deviations were detected during the blind review meeting.	cm	MEAN
SECONDARY	Change From Baseline in WOMAC OA Scores	Day 182 or early termination	Intention-to-treat	score	MEAN
SECONDARY	Absolute Changes From Baseline in Pain Visual Analogue Scale	Day 182 or early termination	Intention-to-treat	score	MEAN
SECONDARY	OARSI Responders	Day 182 or early termination	Intentio-to-treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Assessment of Joint Swelling, Effusion or Both	Day 182 or early termination	Intent-to-treat	participants	NUMBER
SECONDARY	Consumption of Acetaminophen	Day 182 or early termination	Intention-to-treat	tablets	MEAN
SECONDARY	Change From Baseline in Patient's Global Assessment of Disease Activity	Day 182 or early termination	Intention-to-treat	score	MEAN
SECONDARY	Global Assessment of Response to Therapy	Day 182 or early termination	Intention-To-Treat	score on a scale	MEAN
SECONDARY	Quality of Life SF-36	Day 182 or early termination	Intention-To-Treat	score on a scale	MEAN
OTHER_PRE_SPECIFIED	Cartilage Volume Loss From Baseline in the Medial Compartment Using MRI	baseline and 728 days	Exploratory ITT	percentage of volume loss	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group46

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change Form Baseline in WOMAC A Pain Subscale	Diacerein		-11.14	Standard Error 0.91	cm
Change Form Baseline in WOMAC A Pain Subscale	Celecoxib		-11.82	Standard Error 0.89	cm
Change From Baseline in WOMAC OA Scores	Diacerein	Total Score	-41.0	Standard Deviation 53.1	score
Change From Baseline in WOMAC OA Scores	Celecoxib	Total Score	-42.9	Standard Deviation 55.0	score
Change From Baseline in WOMAC OA Scores	Diacerein	Pain Score	-10.03	Standard Deviation 11.95	score
Change From Baseline in WOMAC OA Scores	Celecoxib	Pain Score	-9.60	Standard Deviation 12.02	score
Change From Baseline in WOMAC OA Scores	Diacerein	Stiffness Score	-3.56	Standard Deviation 4.99	score
Change From Baseline in WOMAC OA Scores	Celecoxib	Stiffness Score	-3.99	Standard Deviation 5.32	score
Change From Baseline in WOMAC OA Scores	Diacerein	Physical Function Score	-27.2	Standard Deviation 39.0	score
Change From Baseline in WOMAC OA Scores	Celecoxib	Physical Function Score	-29.3	Standard Deviation 39.8	score

1 to 10 of 46Source ClinicalTrials.gov

See all 46 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Diacerein	187
Overall Study	STARTED	Celecoxib	193
Overall Study	COMPLETED	Diacerein	141
Overall Study	COMPLETED	Celecoxib	149
Overall Study	NOT COMPLETED	Diacerein	46
Overall Study	NOT COMPLETED	Celecoxib	44

Source ClinicalTrials.gov

Adverse events106

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
other	Abdominal pain	Gastrointestinal disorders	Diacerein	6	186	7
other	Abdominal pain	Gastrointestinal disorders	Celecoxib	2	190	2
other	Abdominal pain upper	Gastrointestinal disorders	Diacerein	4	186	4
other	Abdominal pain upper	Gastrointestinal disorders	Celecoxib	1	190	1
other	Abdominal tenderness	Gastrointestinal disorders	Diacerein	0	186	0
other	Abdominal tenderness	Gastrointestinal disorders	Celecoxib	1	190	1
other	Chromaturia	Gastrointestinal disorders	Diacerein	5	186	5
other	Chromaturia	Gastrointestinal disorders	Celecoxib	0	190	0
other	Constipation	Gastrointestinal disorders	Diacerein	2	186	2
other	Constipation	Gastrointestinal disorders	Celecoxib	0	190	0

1 to 10 of 106Source ClinicalTrials.gov

See all 106 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Diacerein	0	186
Total, all-cause mortality	Celecoxib	0	190
Total, other adverse events	Diacerein	49	186
Total, other adverse events	Celecoxib	33	190
Total, serious adverse events	Diacerein	3	186
Total, serious adverse events	Celecoxib	4	190

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
6133942	BACKGROUND	PubMed
9558181	BACKGROUND	PubMed
9858439	BACKGROUND	PubMed
10806046	BACKGROUND	PubMed
18050202	BACKGROUND	PubMed
19857509	BACKGROUND	PubMed
32521015	DERIVED	PubMed

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 comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Diacerein vs Celecoxib: OARSI Responders	Trial comparisons
Diacerein vs Celecoxib: deaths from any cause	Trial comparisons
Diacerein vs Celecoxib: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02688400

GET https://conductscience.org/api/trials/v1/NCT02688400/results?page=2

API reference For AI assistants