NCT00448110

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
331

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2006

Geographic Reach
1 country

14 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

May 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

May 22, 2009

Status Verified

May 1, 2009

Enrollment Period

1.5 years

First QC Date

March 13, 2007

Last Update Submit

May 21, 2009

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Sum of the pain intensity differences (SPID) over the 0-48 hour time interval.

    0-48 hours

Secondary Outcomes (2)

  • SPID over the 0-24 hour interval

    0-24 hours

  • Other measures of pain relief

    Multiple

Study Arms (4)

A

EXPERIMENTAL

intravenous diclofenac dosage level 1

Drug: Intravenous Diclofenac (DIC075V)

B

EXPERIMENTAL

intravenous diclofenac dosage level 2

Drug: Intravenous Diclofenac (DIC075V)

C

ACTIVE COMPARATOR

intravenous ketorolac

Drug: Intravenous Ketorolac

D

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

Intravenous Diclofenac (DIC075V)DRUG

Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels

AB
Intravenous KetorolacDRUG

Intravenous Ketorolac

C
placeboDRUG

placebo

D

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

Eliza Coffee Memorial Hospital

Florence, Alabama, 35630, United States

Location

Drug Research and Analysis Corp.

Montgomery, Alabama, 36106, United States

Location

Helen Keller Hospital

Sheffield, Alabama, 35660, United States

Location

Teton Research / Parkview Surgical

Little Rock, Arkansas, 72205, United States

Location

Glendale Adventist Medical Center

Glendale, California, 91206, United States

Location

Saddleback Memorial Medical Center

Laguna Hills, California, 92653, United States

Location

Visions Clinical Research

Boynton Beach, Florida, 33437, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Clinical Research Services

Bismarck, North Dakota, 58501, United States

Location

Clinical Research Center

Austin, Texas, 78705, United States

Location

Memorial Hermann Healthcare System - Memorial City Hospital

Houston, Texas, 77024, United States

Location

Clinical Research Center

San Marcos, Texas, 78666, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Related Publications (2)

  • Chelly JE, Lacouture PG, Reyes CRD. Safety of Injectable HPbetaCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials. Drugs Aging. 2018 Mar;35(3):249-259. doi: 10.1007/s40266-018-0529-3.

    PMID: 29492863DERIVED

  • Gan TJ, Daniels SE, Singla N, Hamilton DA, Carr DB. A novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter, double-blind, randomized, multiple-dose study. Anesth Analg. 2012 Nov;115(5):1212-20. doi: 10.1213/ANE.0b013e3182691bf9. Epub 2012 Aug 10.

    PMID: 22886837DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Javelin Pharmaceuticals

    Javelin Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 13, 2007

First Posted

March 15, 2007

Study Start

May 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

May 22, 2009

Record last verified: 2009-05

Locations

US(14)