Trial Outcomes & Findings for Sleep and Endometrial Cancer (NCT NCT00936598)
NCT ID: NCT00936598
Last Updated: 2014-04-24
Results Overview
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).
TERMINATED
NA
6 participants
at the clinical follow-up appointment approximately 7-10 days after surgery
2014-04-24
Participant Flow
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.
One participant in the placebo group was found to be ineligible after consent before starting the study (before being provided with take home materials).
Participant milestones
| Measure |
Zolpidem
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.
|
Sugar Pill
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 Study
STARTED
|
4
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Zolpidem
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.
|
Sugar Pill
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 Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Ineligible after consent
|
1
|
0
|
Baseline Characteristics
Sleep and Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Zolpidem
n=4 Participants
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.
|
Sugar Pill
n=1 Participants
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
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 20.7 • n=99 Participants
|
60 years
STANDARD_DEVIATION 0 • n=107 Participants
|
54.4 years
STANDARD_DEVIATION 18.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
1 participants
n=107 Participants
|
5 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at the clinical follow-up appointment approximately 7-10 days after surgeryPopulation: Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: each of the days following surgery until the clinical follow-up appointmentPopulation: Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.
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."
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: daily from the day of surgery until the clinical follow-up appointmentPopulation: Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.
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.
Outcome measures
Outcome data not reported
Adverse Events
Zolpidem
Sugar Pill
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place