NCT01967550

Brief Summary

This study will evaluate the efficacy and safety of diclofenac DDEA 2.32 % in patient suffering from knee osteoarthritis (OA).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 3, 2015

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

7 months

First QC Date

October 18, 2013

Results QC Date

April 28, 2015

Last Update Submit

June 2, 2015

Conditions

Osteoarthritis, Knee

Keywords

Symptomatic knee OA Kellgren-Lawrence grade 1-3

Outcome Measures

Primary Outcomes (1)

  • Measure: Pain On Movement (POM)

    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.

    2 weeks

Study Arms (2)

diclofenac diethylamine, DDEA 2.32% gel

EXPERIMENTAL

diclofenac diethylamine, DDEA 2.32% gel

Drug: diclofenac diethylamine, DDEA 2.32% gel

Placebo

PLACEBO COMPARATOR

Vehicle control

Drug: Placebo

Interventions

diclofenac diethylamine, DDEA 2.32% gelDRUG
diclofenac diethylamine, DDEA 2.32% gel
PlaceboDRUG
Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Male or female ≥ 50 years old; 2. Symptomatic OA of one or both knees, according to ACR criteria, diagnosed at least 6 months previously; 3. Pain in either knee originates in the knee (not referred pain from other sites, such as hip or back) and no other cause of pain than knee OA; 4. Have used oral NSAIDs or COXIBs for the knee OA pain (including aspirin if ≥ 500 mg and used in this indication), at least one dose per day, for not less than 10 days out of the 14 days preceding the screening visit and also within the 24 hours preceding the screening visit; 5. Be able to tolerate rescue medication with only 500 mg paracetamol (APAP) taken in doses of 1-2 tablets up to a maximum of 6 tablets (3 grams) per day for the duration of the study

You may not qualify if:

  • \- 1. Partial or total replacement of either knee joint, past or planned/expected during study duration.
  • \. OA of the knee due to other underlying conditions, such as gout, chondrocalcinosis, hemochromatosis, joint infections, neuropathia, or severe traumatic joint damage (however, common risk factors, such as obesity and past meniscectomy or ligament rupture and repair, are allowed); 3. History of systemic inflammatory (autoimmune) disease (rheumatoid arthritis, systemic psoriasis, systemic lupus erythematosus, systemic sclerosis, etc.) or laboratory values indicative of such disease with subsequent diagnosis by a physician; 4. Fibromyalgia within the previous year; 5. Allergy or asthma to diclofenac, APAP, aspirin, other NSAIDs or any of the ingredients in the gel (i.e. isopropyl alcohol, propylene glycol, or butylhydroxytoluene), or any other contraindication for the study drug or the rescue medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Bad Hersfeld, Germany

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Munich, Germany

Location

Unknown Facility

Stockach, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

diclofenac diethylaminedi-N-desethylamiodaroneGels

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Clinical Project Leader pain category
Organization
Novartis Consumer Health
+41223633111

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2013

First Posted

October 23, 2013

Study Start

October 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 3, 2015

Results First Posted

June 3, 2015

Record last verified: 2015-06

Locations

DE(5)