Parecoxib In Post Surgery (Hemicolectomy) Pain | NCT00139607

Studies
Parecoxib In Post Surgery (Hemicolectomy) Pain

NCT00139607

Sponsor

Pfizer

Status

Terminated

Last Update Posted

Aug 14, 2009Estimated

Enrollment

Phase

Phase 3

Conditions

Colectomy

Interventions

Paracoxib

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
A3481022

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Please see detailed description for termination reason.

Expanded Access Info

Start Date

Sep 2002

Primary Completion Date

Not provided

Completion Date

Jan 2005

First Submitted Date

Aug 29, 2005

First Submission Date that Met QC Criteria

Aug 29, 2005

First Posted Date

Aug 31, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2009

Last Update Posted Date

Aug 14, 2009Estimated

Description Module

Brief Summary

This is a phase III, multicenter, open label, pilot to evaluate the analgesic efficacy and safety of parecoxib 40 mg IV in the treatment of the pain following hemicolectomy in an optimal management of the surgical patient

Detailed Description

The study was terminated prematurely due to recruitment issues on 31 January 2006. Safety concerns did not lead to the decision to terminate this study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Paracoxib	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of efficacy assessments based on pain intensity (VAS) and on Pain relief (PR).

Secondary Outcomes

Measure	Description	Time Frame
Time between the first administration of parecoxib and the first request of morphine The total amount of morphine in the first 24 hours of treatment and the total amount of morphine given during the entire period of treatment with parecoxib

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients hospitalised for resection of left/right colon;
preoperative health graded as ASA <3.

Exclusion Criteria:

patients with any type of metastatic cancer, particularly metastatic colon cancer;
patients with familial adenomatous polyps (sporadic adenomatous polyps are accepted);

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Biella		13051	Italy
Pfizer Investigational Site