Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers

Javelin Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: intravenous diclofenac sodium (DIC075V); Drug: ketorolac; Drug: oral diclofenac (Cataflam); Drug: aspirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00548678

DFC-007

Details and patient eligibility

About

This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.

Full description

The primary objective is to evaluate platelet function following intravenous diclofenac, oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects.
• Willing and able to stay at the clinical site for approximately 8 nights over 9 days and to return to the clinic approximately 7 days after discharge.

Exclusion criteria

• Bleeding abnormalities or cardiovascular events.
• Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 4 patient groups

A

Experimental group

Description:

intravenous diclofenac sodium

Treatment:

Drug: intravenous diclofenac sodium (DIC075V)

B

Active Comparator group

Description:

intravenous ketorolac

Treatment:

Drug: ketorolac

C

Active Comparator group

Description:

oral diclofenac (Cataflam)

Treatment:

Drug: oral diclofenac (Cataflam)

D

Active Comparator group

Description:

oral aspirin

Treatment:

Drug: aspirin