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Preemptive Analgesia Following Uterine Artery Embolization

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ClinicalTrials.gov Identifier: NCT01555073
Recruitment Status : Terminated (Subjects did not meet inclusion criteria)
First Posted : March 15, 2012
Results First Posted : September 18, 2014
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Antoun Nader, Northwestern University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Uterine Fibroids
Uterine Artery Embolization
Interventions: Drug: pregabalin/celecoxib
Drug: pregabalin/placebo
Drug: celecoxib/placebo
Drug: Placebo group

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pregabalin/Celecoxib Group

pregabalin/celecoxib twice a day for 13 days.

pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.
Pregabalin/Placebo Group

pregabalin/placebo twice a day for 13 days.

pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.
Celecoxib/Placebo Group

celecoxib/placebo twice a day for 13 days.

celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.
Placebo Group

Placebo group, two placebo tablets day of surgery and twice a day for 13 days

Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days

Participant Flow:   Overall Study
    Pregabalin/Celecoxib Group   Pregabalin/Placebo Group   Celecoxib/Placebo Group   Placebo Group
STARTED   7   3   7   6 
COMPLETED   6   1   7   1 
NOT COMPLETED   1   2   0   5 
Lost to Follow-up                1                2                0                5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline Analysis population description

Reporting Groups
  Description
Pregabalin/Celecoxib Group

pregabalin/celecoxib twice a day for 13 days.

pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.
Pregabalin/Placebo Group

pregabalin/placebo twice a day for 13 days.

pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.
Celecoxib/Placebo Group

celecoxib/placebo twice a day for 13 days.

celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.
Placebo Group

Placebo group, two placebo tablets day of surgery and twice a day for 13 days

Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days
Total Total of all reporting groups

Baseline Measures
   Pregabalin/Celecoxib Group   Pregabalin/Placebo Group   Celecoxib/Placebo Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 7   3   7   6   23 
Age 
[Units: Participants]
 		         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   7   3   7   6   23 
>=65 years   0   0   0   0   0 
Gender 
[Units: Participants]
 		         
Female   7   3   7   6   23 
Male   0   0   0   0   0 


  Outcome Measures

1.  Primary:   Post Operative Pain Control   [ Time Frame: Expected average of 12 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Quality of Life   [ Time Frame: Expected average of 12 weeks ]
  Show Outcome Measure 2


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination due to lost of follow-up for primary outcome at 3 months


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Antoun Nader, MD
Organization: Northwestern University, Feinberg School of Medicine
phone: 312-695-3045
e-mail: a-nader2@northwestern.edu



Responsible Party: Antoun Nader, Northwestern University
ClinicalTrials.gov Identifier: NCT01555073     History of Changes
Other Study ID Numbers: STU00004604
First Submitted: October 14, 2011
First Posted: March 15, 2012
Results First Submitted: September 11, 2014
Results First Posted: September 18, 2014
Last Update Posted: July 28, 2016