Study To Investigate The Effectiveness Of Pregabalin For Management Of Patients Undergoing Total Hip Replacement

NCT00905437 | Terminated Phase 3 Results

• 1 other identifier: A0081229
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is the investigate if pregabalin started a day before surgery and continued for 14 days post-operatively can reduce post-operative pain, relieve pre- and post-operative anxiety and sleep disturbances.

Conditions

Pain, Perioperative

Keywords

perioperative; pregabalin; total hip replacement; post-operative pain

Outcome Measures

Primary Outcomes (1)

• Mean Pain on Movement Score

  Mean pain on movement score was defined as the mean of the pain on movement score over Days 1 to 5 post-surgery. Pain experienced by participant during passive flexion through 90 degree and passive abduction through 30 degree at operated hip joint was evaluated on a scale of 0 to 10 where, 0= no pain and 10= worst possible pain.

  Every 12 hours from Day 1 to Day 5 post-surgery

Secondary Outcomes (6)

• Mean Daily Pain Score

  Day 1 to Day 7, Day 8 to Day 14 post-surgery

• Mean Daily Sleep Interference Score

  Day 1 to Day 5 post-surgery

• Mean Anxiety Visual Analogue Scale (A-VAS)

  Day 0 to Day 5 post-surgery

• Time to Mobilization After Surgery

  Day 1 to Day 5 post-surgery

• Number of Participants With Rescue Medication Usage

  Day 0 to Day 6 post-surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo as an adjunct to standard of care

Drug: Placebo

Pregabalin

ACTIVE COMPARATOR

Pregabalin as an adjunct to standard of care

Drug: Pregabalin

Interventions

Placebo DRUG

Placebo as an adjunct to standard of care

Placebo

Pregabalin DRUG

75 mg BD for 14 days

Pregabalin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is undergoing a routine (i.e., expected to be uncomplicated) total primary or secondary hip replacement surgery performed under a standardized regimen of spinal anesthesia, and is expected to experience moderate to severe post-surgical pain in the absence of post-operative analgesia

You may not qualify if:

• The patient is undergoing a revision to a previous hip replacement procedure, hip replacement procedure further to a road traffic accident with multiple injuries, or a procedure expected to last longer than 4 hours
• The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition, which in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (7)

Pfizer Investigational Site

Hyderabad, Andhra Pradesh, 500 033, India

Location

Pfizer Investigational Site

Ahmedabad, Gujarat, 380 015, India

Location

Pfizer Investigational Site

Bangalore, Karnataka, 560 076, India

Location

Pfizer Investigational Site

Kanpur, Uttar Pradesh, 208 001, India

Location

Pfizer Investigational Site

Kanpur, Uttar Pradesh, 208 002, India

Location

Pfizer Investigational Site

Kolkata, West Bengal, 700 054, India

Location

Pfizer Investigational Site

New Delhi, 110 017, India

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

As the enrollment rate was very low, the study was prematurely terminated. The number of enrolled participants was too low for meaningful formal statistical conclusions.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 20, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 28, 2021
• Results First Posted: June 11, 2013

Record last verified: 2021-01

Locations

IN (7)