Trial · NCT01967550

Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA)

NCT01967550, Phase 3, Completed, Novartis; results first posted 2015-06-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA). Trials, record NCT01967550. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01967550

On this page

Trial

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

Title: Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA)
NCT number: NCT01967550
Status: Completed
Phases: Phase 3
Enrollment: 304 participants, actual
Lead sponsor: Novartis
Conditions: Osteoarthritis, Knee
Interventions: diclofenac diethylamine, DDEA 2.32% gel, Placebo
First posted: 2013-10-23
Last updated: 2015-06-03
Other registries' IDs: eudract:2012-004024-38
Results first posted: 2015-06-03

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Measure: Pain On Movement (POM)	2 weeks	POM will be assessed by subject on a 100 mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 with higher score indicating higher levels of pain.

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	Measure: Pain On Movement (POM)	2 weeks	The modified ITT (mITT) population excludes subjects in the ITT population who were incorrectly instructed by the investigator to treat only one knee. The mITT population is primary for the analysis of efficacy.	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
Measure: Pain On Movement (POM)	Diclofenac Diethylamine, DDEA 2.32% Gel		42.9	Standard Deviation 23.8	units on a scale
Measure: Pain On Movement (POM)	Placebo		42.1	Standard Deviation 23.5	units on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Diclofenac Diethylamine, DDEA 2.32% Gel	153
Overall Study	STARTED	Placebo	151
Overall Study	COMPLETED	Diclofenac Diethylamine, DDEA 2.32% Gel	148
Overall Study	COMPLETED	Placebo	149
Overall Study	NOT COMPLETED	Diclofenac Diethylamine, DDEA 2.32% Gel	5
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events102

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	Headache	Nervous system disorders	Diclofenac Diethylamine, DDEA 2.32% Gel	18	153	18
other	Headache	Nervous system disorders	Placebo	18	151	18
other	Nasopharyngitis	Infections and infestations	Diclofenac Diethylamine, DDEA 2.32% Gel	4	153	4
other	Nasopharyngitis	Infections and infestations	Placebo	10	151	10
other	Contusion	Musculoskeletal and connective tissue disorders	Diclofenac Diethylamine, DDEA 2.32% Gel	5	153	5
other	Contusion	Musculoskeletal and connective tissue disorders	Placebo	3	151	3
other	Back pain	Musculoskeletal and connective tissue disorders	Diclofenac Diethylamine, DDEA 2.32% Gel	4	153	4
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo	3	151	3
other	Abdominal pain upper	Gastrointestinal disorders	Diclofenac Diethylamine, DDEA 2.32% Gel	3	153	3
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	1	151	1

1 to 10 of 102Source ClinicalTrials.gov

See all 102 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Diclofenac Diethylamine, DDEA 2.32% Gel
Total, all-cause mortality	Placebo
Total, other adverse events	Diclofenac Diethylamine, DDEA 2.32% Gel	48	153
Total, other adverse events	Placebo	47	151
Total, serious adverse events	Diclofenac Diethylamine, DDEA 2.32% Gel	0	153
Total, serious adverse events	Placebo	0	151

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons1

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

Comparison
Diclofenac Diethylamine, DDEA 2.32% Gel vs Placebo: serious adverse events

Source 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/NCT01967550

GET https://conductscience.org/api/trials/v1/NCT01967550/events?page=2

API reference For AI assistants