Effects of a Cyclic NSAID Regimen on Levels of GCF PGE-E2 and IL-1beta

PHASE2CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

January 31, 2000

Primary Completion Date

December 31, 2004

Study Completion Date

December 31, 2004

Conditions
Non-steroidal Anti-inflammatory Poisoning
Interventions
DRUG

cataflam (diclofenac potassium)

Cataflam (diclofenac potassium, 50 mg) b.i.d. after a meal for 6 months in a cyclic regimen. Administration of diclofenac potassium was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly.

DRUG

placebo

"Placebo gel caps (containing inactive filler of starch flour and carboxymethylcellulose) b.i.d. after a meal for 6 months in a cyclic regimen.~Administration of placebo was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly."

All Listed Sponsors
lead

Baskent University

OTHER

NCT02658799 - Effects of a Cyclic NSAID Regimen on Levels of GCF PGE-E2 and IL-1beta | Biotech Hunter | Biotech Hunter