Pelvic PainPhase 4NCT00440505

Effect of Nicotine on Chronic Pelvic Pain

A Phase 4 study testing Nicotine (5 mg) and Nicotine (10 mg) in people with Pelvic Pain, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain. Read more about this study

Who is it for?: Ages 18 to 60 years, women only
Conditions the study is for: Pelvic Pain
What is being tested?: Nicotine (5 mg) and Nicotine (10 mg)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Feb 2004to Jun 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Women only
No healthy volunteers
Adult

Who may be able to join

Chronic pelvic pain
Aged 18-60 years
Female

Who cannot join

Uncontrolled hypertension
Cardiovascular disease
Current analgesic abuse
Pregnancy
Current usage of nicotine patch or gum
Allergy to adhesive tape

Trial locations and contacts

1 site in 1 country.

United States1 site

Columbia University Medical Center
New York, New York, 10032

Other trials in United States

About this study

The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain.

Read the detailed description

Potential subjects are female non-smokers presenting to their physicians for treatment of chronic pelvic pain. When consented, the subjects fill out a questionnaire on demographic information and pain experience. The trial is conducted at home over three days. Each subject uses three different levels of nicotine (0mg, 5mg, and 10mg) administered in a random order; the study is double-blinded and patients act as their own controls. Subjects apply the placebo or nicotine patches in the morning and remove them in the evening when they fill out a pain diary for the day. During the study, patients will continue their typical course of pain medication and report pain medication use in the pain diary.

Conditions: Pelvic Pain
Being tested: Placebo, Nicotine (5 mg), Nicotine (10 mg)
Keywords: chronic pain, pelvic pain, nicotine patch
Medical subject headings: Pelvic Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.
Nicotine (5 mg)Drug
Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day.
Nicotine (10 mg)Drug
Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.

Study groups in NCT00440505
Study group	Role	What they receive
Placebo	Placebo comparator	Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day. Receives: Drug: Placebo
Nicotine (5 mg)	Experimental	Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day. Receives: Drug: Nicotine (5 mg)
Nicotine (10 mg)	Experimental	Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day. Receives: Drug: Nicotine (10 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Score
Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.
Measured: 1 day

Secondary outcomes (3)

Patient Self-assessment of Psychological Distress
Patient self-assessment of psychological distress in brief rating scale with no psychological distress=0 and maximum psychological distress=90.
Measured: 1 day
Number of Participants Who Reported an Increase in Daily Pain Medication Regime
Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime.
Measured: 1 day
Nausea
Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2004Jun 2008

First posted27 Feb 2007 (estimated)
Study startFeb 2004
Primary completionJun 2008
Study completionJun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pelvic PainStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00440505
Sponsor's protocol ID: AAAA4808
Status last verified: Jul 2018
First submitted: 26 Feb 2007
Last updated: 14 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pelvic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Nicotine on Chronic Pelvic Pain
ClinicalTrials.gov ID: NCT00440505
Acronym / sponsor ID: AAAA4808
Conditions: Pelvic Pain
Keywords: chronic pain, pelvic pain, nicotine patch
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Study start: Feb 2004
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 27 Feb 2007 (estimated)
Results: Posted 9 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboSubjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.
Nicotine (5 mg)	Experimental	Drug: Nicotine (5 mg)Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day.
Nicotine (10 mg)	Experimental	Drug: Nicotine (10 mg)Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Chronic pelvic pain
Aged 18-60 years
Female

Key exclusion criteria (6 listed)

Uncontrolled hypertension
Cardiovascular disease
Current analgesic abuse
Pregnancy
Current usage of nicotine patch or gum

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboSubjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.	Drug	Placebo
Nicotine (5 mg)Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day.	Drug	Nicotine (5 mg)
Nicotine (10 mg)Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.	Drug	Nicotine (10 mg)

Primary outcome

Pain Score
Time frame: 1 day
Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.

3 secondary outcomes

Patient Self-assessment of Psychological Distress
Time frame: 1 day
Number of Participants Who Reported an Increase in Daily Pain Medication Regime
Time frame: 1 day
Nausea
Time frame: 1 day

Results and safety

Results posted to the registry on 9 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo First, Then Nicotine 5 mg, Then Nicotine 10 mg	5	5
Placebo First, Then Nicotine 10 mg, Then Nicotine 5 mg	2	2
Nicotine 5 mg First, Then Nicotine 10 mg, Then Placebo	1	1
Nicotine 5 mg First, Then Placebo, Then Nicotine 10 mg	2	2
Nicotine 10 mg First, Then Nicotine 5 mg, Then Placebo	5	5
Nicotine 10 mg First, Then Placebo, Then Nicotine 5 mg	5	5

Primary outcome: Pain Score

Time frame: 1 day. Mean (Standard Deviation). Unit: Units on a scale

Measure	Placebo n = 20	Nicotine 5 mg n = 20	Nicotine 10 mg n = 19
Value	7.1 (3.1)	6.4 (3.0)	6.9 (3.2)

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 20 (0%)	0 of 20 (0%)	Not reported
Nicotine 5mg	0 of 20 (0%)	0 of 20 (0%)	Not reported
Nicotine 10mg	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Postpartum Pelvic Girdle Pain
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Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pamela Flood, MD principal investigator

Columbia University

Jessamyn Conell-Price, BA study director

Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nicotine (5 mg) and Nicotine (10 mg) in people with Pelvic Pain, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Score (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00440505.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.