Trial Outcomes & Findings for Effect of Nicotine on Chronic Pelvic Pain (NCT NCT00440505)
NCT ID: NCT00440505
Last Updated: 2018-08-14
Results Overview
Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.
COMPLETED
PHASE4
20 participants
1 day
2018-08-14
Participant Flow
This double-blind prospective study was approved by the Institutional Review Board of Columbia University Medical Center. Written consent was obtained from all subjects. Women presenting with chronic pelvic pain to a gynecologist or to the pain clinic at New York Presbyterian Hospital were eligible for inclusion.
Twenty-six women were recruited for the study. Six women declined to participate after consenting but before commencing treatment; these women are not included in the analysis.
Participant milestones
| Measure |
Placebo First, Then Nicotine 5 mg, Then Nicotine 10 mg
Placebo patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period.
|
Placebo First, Then Nicotine 10 mg, Then Nicotine 5 mg
Placebo patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period.
|
Nicotine 5 mg First, Then Nicotine 10 mg, Then Placebo
Nicotine 5 mg patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period.
|
Nicotine 5 mg First, Then Placebo, Then Nicotine 10 mg
Nicotine 5 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period.
|
Nicotine 10 mg First, Then Nicotine 5 mg, Then Placebo
Nicotine 10 mg patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period.
|
Nicotine 10 mg First, Then Placebo, Then Nicotine 5 mg
Nicotine 10 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period.
|
|---|---|---|---|---|---|---|
|
First Intervention
STARTED
|
5
|
2
|
1
|
2
|
5
|
5
|
|
First Intervention
COMPLETED
|
5
|
2
|
1
|
2
|
5
|
5
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
5
|
2
|
1
|
2
|
5
|
5
|
|
Second Intervention
COMPLETED
|
5
|
2
|
1
|
2
|
5
|
5
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
5
|
2
|
1
|
2
|
5
|
5
|
|
Third Intervention
COMPLETED
|
5
|
2
|
1
|
1
|
5
|
5
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Nicotine on Chronic Pelvic Pain
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=20 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: This analysis was per protocol. One patient dropped out of the study before the third intervention period. This patient does not have data for the 10 mg nicotine patch.
Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
|
Nicotine 5 mg
n=20 Participants
Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
|
Nicotine 10 mg
n=19 Participants
Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
|
|---|---|---|---|
|
Pain Score
|
7.1 Units on a scale
Standard Deviation 3.1
|
6.4 Units on a scale
Standard Deviation 3.0
|
6.9 Units on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 1 dayPopulation: This analysis was per protocol. One patient dropped out of the study before the third intervention period. This patient does not have data for the 10 mg nicotine patch.
Patient self-assessment of psychological distress in brief rating scale with no psychological distress=0 and maximum psychological distress=90.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
|
Nicotine 5 mg
n=20 Participants
Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
|
Nicotine 10 mg
n=19 Participants
Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
|
|---|---|---|---|
|
Patient Self-assessment of Psychological Distress
|
40.2 Units on a scale
Standard Deviation 18.3
|
36.7 Units on a scale
Standard Deviation 18.6
|
37.5 Units on a scale
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: 1 dayPopulation: This analysis was per protocol. Only data from those patients who returned the pain diaries with the above information to the research staff by mail were included in the analysis.
Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime.
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
|
Nicotine 5 mg
n=13 Participants
Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
|
Nicotine 10 mg
n=13 Participants
Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
|
|---|---|---|---|
|
Number of Participants Who Reported an Increase in Daily Pain Medication Regime
|
2 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 dayPopulation: This analysis was per protocol. Only data from those patients who returned the pain diaries with the above information to the research staff by mail were included in the analysis.
Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
|
Nicotine 5 mg
n=13 Participants
Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
|
Nicotine 10 mg
n=13 Participants
Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
|
|---|---|---|---|
|
Nausea
|
2.3 Units on a scale
Standard Deviation 1.8
|
2.3 Units on a scale
Standard Deviation 2.1
|
2.3 Units on a scale
Standard Deviation 2.1
|
Adverse Events
Placebo
Nicotine 5mg
Nicotine 10mg
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