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Sleep and Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT00936598
Recruitment Status : Terminated (Investigator-initiated termination of approval due to problems with recruitment.)
First Posted : July 10, 2009
Results First Posted : July 20, 2012
Last Update Posted : April 24, 2014
Sponsor:
Information provided by (Responsible Party):
Dana Bovbjerg, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Sleep
Endometrial Neoplasms
Pain
Interventions Drug: zolpidem
Drug: sugar pill
Enrollment 6
Recruitment Details Recruitment occurred between January 2010 and May 2010 at Magee Womens Hospital and Mercy Hospital. All participants who were recruited were assigned to one arm or the other.
Pre-assignment Details One participant in the placebo group was found to be ineligible after consent before starting the study (before being provided with take home materials).
Arm/Group Title Zolpidem Sugar Pill
Hide Arm/Group Description Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute. Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
Period Title: Overall Study
Started 4 1
Completed 2 1
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             1             0
Ineligible after consent             1             0
Arm/Group Title Zolpidem Sugar Pill Total
Hide Arm/Group Description Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute. Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute. Total of all reporting groups
Overall Number of Baseline Participants 4 1 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 1 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  75.0%
1
 100.0%
4
  80.0%
>=65 years
1
  25.0%
0
   0.0%
1
  20.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 1 participants 5 participants
53  (20.7) 60  (0) 54.4  (18.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 1 participants 5 participants
Female
4
 100.0%
1
 100.0%
5
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 1 participants 5 participants
4 1 5
1.Primary Outcome
Title Brief Pain Inventory (Short-form)
Hide Description Pain intensity and pain interference subscales from the Brief Pain Inventory (Short-form) (BPI) will be used to measure pain over the interval following surgery. Both subscales have a range of 0-10 with higher scores indicating worse outcomes (more intense pain and more pain interference).
Time Frame at the clinical follow-up appointment approximately 7-10 days after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.
Arm/Group Title Zolpidem Sugar Pill
Hide Arm/Group Description:
Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Pain Severity Visual Analogue Scale
Hide Description Pain severity will be assessed daily following surgery with a visual analogue scale (VAS) completed by participants each night before they go to bed (daily diary PM). VAS pain severity yields a score of 0 to 100, with 100 indicating pain "as bad as it could be."
Time Frame each of the days following surgery until the clinical follow-up appointment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.
Arm/Group Title Zolpidem Sugar Pill
Hide Arm/Group Description:
Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Daily Analgesic Medication Consumption (Morphine Equivalency)
Hide Description Analgesic medication consumption will be calculated (morphine equivalent daily dose (MEDD)) on a daily basis using data down loaded from the patient-controlled analgesia (PCA) pump supplemented by information from clinical charts and patient self report on the daily diary form. MEDD starts at zero and does not have an upper limit; higher daily doses indicate more analgesic medication consumption, and thus more pain.
Time Frame daily from the day of surgery until the clinical follow-up appointment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.
Arm/Group Title Zolpidem Sugar Pill
Hide Arm/Group Description:
Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zolpidem Sugar Pill
Hide Arm/Group Description Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute. Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
All-Cause Mortality
Zolpidem Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Zolpidem Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zolpidem Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Professor
Organization: University of Pittsburgh
Phone: 412-623-5965
Responsible Party: Dana Bovbjerg, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00936598     History of Changes
Other Study ID Numbers: PRO09040160
PCI-09-027 ( Other Identifier: University of Pittsburgh Cancer Institute )
First Submitted: July 8, 2009
First Posted: July 10, 2009
Results First Submitted: June 15, 2012
Results First Posted: July 20, 2012
Last Update Posted: April 24, 2014