Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery

Randomized, Double-Blind, Active- and Placebo-Controlled Study of the Efficacy and Safety of Repeated Dosing of DIC075V Relative To Parenteral Ketorolac and Placebo in Patients With Acute Post-Op Pain After Abdominal or Pelvic Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00448110

Enrollment

331

Registered

2007-03-15

Start date

2006-05-31

Completion date

2007-11-30

Last updated

2009-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Brief summary

This study will compare repeated intermittent IV dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic surgery.

Detailed description

The primary objective is to evaluate the efficacy and safety of two dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.

Interventions

DRUGIntravenous Diclofenac (DIC075V)

Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels

DRUGIntravenous Ketorolac

Intravenous Ketorolac

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Scheduled within two weeks of the screening visit to undergo abdominal or pelvic surgery * Moderate to severe pain within 6 hours following completion of the required surgery.

Exclusion criteria

* Surgical procedure involves a subcostal incision. * Chronic disease or recent cardiovascular events. * Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study. Additional Inclusion/

Design outcomes

Primary

Measure	Time frame
Sum of the pain intensity differences (SPID) over the 0-48 hour time interval.	0-48 hours

Secondary

Measure	Time frame
SPID over the 0-24 hour interval	0-24 hours
Other measures of pain relief	Multiple

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026