Preemptive Analgesia Following Uterine Artery Embolization

This study has been terminated.

(Subjects did not meet inclusion criteria)

Sponsor:

Information provided by (Responsible Party):

Antoun Nader, Northwestern University

ClinicalTrials.gov Identifier:

NCT01555073

First received: October 14, 2011

Last updated: June 29, 2016

Last verified: June 2016

History of Changes

Results First Received: September 11, 2014

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

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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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

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1. Primary:

Post Operative Pain Control [ Time Frame: Expected average of 12 weeks ]

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2. Secondary:

Quality of Life [ Time Frame: Expected average of 12 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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

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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
Study First Received:	October 14, 2011
Results First Received:	September 11, 2014
Last Updated:	June 29, 2016

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