Abdominal PainPhase 4NCT00310765

Pregabalin for Abdominal Pain From Adhesions

A Phase 4 study testing Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks in people with Abdominal Pain and Surgical Adhesions, run by Henry Ford Health System at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Abdominal Pain, Surgical Adhesions
What is being tested?: Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Mar 2006to Aug 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must have history of prior surgery and documented adhesions during laparoscopy or open laparotomy within 5 years
Must have undergone an evaluation to exclude other causes of abdominal pain
Abdominal pain must be present for greater than three months duration

Who cannot join

Patients that are pregnant or breast feeding
Prior treatment with gabapentin, pregabalin or demonstrated sensitivity to these drugs
Patients who are immunocompromised
Patients with significant hepatic or renal insufficiency, or any significant hematologic disorder
History of illicit alcohol or drug abuse within one year
Documented serious or unstable medical or psychological condition
Malignancy within the past 5 years other than in situ squamous cell carcinoma of the skin

Trial locations and contacts

1 site in 1 country.

United States1 site

Henry Ford Health System
West Bloomfield, Michigan, 48322

Other trials in United States

About this study

Official title: Pregabalin for the Treatment of Abdominal Pain From Adhesions: Placebo Controlled Trial

The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.

Read the detailed description

The study will be prospective, double-blinded and randomized. The study will run for 12 weeks. During the first 7 weeks there will be 2 groups in the study with subjects receiving a placebo or the study drug. During the last 4 weeks of the study, all subjects will be offered the study medication, pregabalin. The primary outcome measure will be pain relief documented by a 2-point change on the Likert pain scale with a secondary pain measure of sleep interruption.

Conditions: Abdominal Pain, Surgical Adhesions
Being tested: Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks, Placebo first followed by open label pregabalin
Keywords: abdominal pain, surgical adhesions
Medical subject headings: Abdominal Pain, Tissue Adhesions

What participants receive

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

Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeksDrug
Also called Lyrica
First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days and treat for 7 weeks. Followed by open label pregabalin for 4 weeks at 150 mg BID
Placebo first followed by open label pregabalinDrug
Also called Look alike placebo followed by open label pregabalin, Lyrica
Look alike placebo 75 mg po BID and increase to 150 mg BID after 3 days if no improvement for 7 weeks. Open label pregabalin 150 mg BID for last 4 weeks of study.

Study groups in NCT00310765
Study group	Role	What they receive
Pregabalin 150 or 300 mg daily for severe abdominal pain from adhesions	Active comparator	Patients were randomly assigned to active drug 75-150 mg of pregabalin po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study. Receives: Drug: Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks
Look alike placebo 150 or 300 mg daily for severe abdominal pain from adhesions	Placebo comparator	Patients were randomly assigned to look alike placebo 75 or 150 mg po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study. Receives: Drug: Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks; Drug: Placebo first followed by open label pregabalin

What is being measured

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

Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo
Patients were randomized to pregabalin or placebo 75 mg twice a day. Patients were allowed to double the dose on day 3 if adequate pain relief was not obtained. Abdominal pain reduction was measured on a Likert scale. A Likert scale assumes the intensity of pain is linear on a continuum from no pain at level 0 to severe pain at level 10. Patients were required to complete a daily dairy recording pain using the Likert 11-point numeric scale. The primary end point was a positive change in the daily pain diary of 2 points from each patient's baseline at weeks 8 after the completion of the blinded study and at week 12 during the open label portion of the study. After 7 weeks all patients are randomized to study drug pregabalin 150 to 300 mg daily for 4 additional weeks after a one week wash out with no medication.
Measured: Baseline and week 2 through week 12

Secondary outcomes (1)

Improved Sleep Scores
Absolute Improvement in Sleep by assessing Mean Daily sleep interference scores as measured weekly starting at baseline and reported weekly through week 12 excluding the first week. This score is an 11 point scale the documents the pain interference in sleep in the preceding 24 hours. 0 is no interference and 10 is pain completely disrupted sleep in the previous 24 hours. During the study patients recorded a daily sleep interference score based on 11 point scale (0-10) with the higher number being the most sleep interference
Measured: Baseline and week 2 through week 12

Timeline

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

Mar 2006Aug 2008

First posted4 Apr 2006 (estimated)
Study startMar 2006
Primary completionAug 2008
Study completionAug 2008

Why it stopped: Study was terminated by the sponsor due to low accrual.

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Abdominal PainStudies of the same condition, open and under way.
More trials run by Henry Ford Health SystemThe 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
Model description: Patients were evaluated for the study and were entered into the study if they had documented abdominal adhesions and a daily pain score of 40 mm on a visual assessment scale and 4 on an eleven point Likert scale (0 none and 10 most pain). Patients were randomly assigned to active drug or look alike placebo for 7 weeks followed by an open label phase in which all patients received active drug pregabalin 300 mg daily for 4 weeks measuring pain and sleep scores during each phase of the study.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00310765
Sponsor's protocol ID: 3727
Status last verified: Sep 2023
First submitted: 31 Mar 2006
Last updated: 23 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Silverman A, Samuels Q, Gikas H, Nawras A. Pregabalin for the treatment of abdominal adhesion pain: a randomized, double-blind, placebo-controlled trial. Am J Ther. 2012 Nov;19(6):419-28. doi: 10.1097/MJT.0b013e318217a5f5.
PubMed 22020082

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?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pregabalin for the Treatment of Abdominal Pain From Adhesions: Placebo Controlled Trial
ClinicalTrials.gov ID: NCT00310765
Acronym / sponsor ID: 3727
Conditions: Abdominal Pain, Surgical Adhesions
Keywords: abdominal pain, surgical adhesions
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated by the sponsor due to low accrual.
Enrolment: 18 participants (actual)
Lead sponsor: Henry Ford Health SystemUniversity, hospital or other
Collaborators: Pfizer
Study start: Mar 2006
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 4 Apr 2006 (estimated)
Results: Posted 23 Oct 2023

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 evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Patients were evaluated for the study and were entered into the study if they had documented abdominal adhesions and a daily pain score of 40 mm on a visual assessment scale and 4 on an eleven point Likert scale (0 none and 10 most pain). Patients were randomly assigned to active drug or look alike placebo for 7 weeks followed by an open label phase in which all patients received active drug pregabalin 300 mg daily for 4 weeks measuring pain and sleep scores during each phase of the study.

Arm	Type	Receives
Pregabalin 150 or 300 mg daily for severe abdominal pain from adhesions	Active comparator	Drug: Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeksPatients were randomly assigned to active drug 75-150 mg of pregabalin po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study.
Look alike placebo 150 or 300 mg daily for severe abdominal pain from adhesions	Placebo comparator	Drug: Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks, Drug: Placebo first followed by open label pregabalinPatients were randomly assigned to look alike placebo 75 or 150 mg po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Must have history of prior surgery and documented adhesions during laparoscopy or open laparotomy within 5 years
Must have undergone an evaluation to exclude other causes of abdominal pain
Abdominal pain must be present for greater than three months duration

Key exclusion criteria (7 listed)

Patients that are pregnant or breast feeding
Prior treatment with gabapentin, pregabalin or demonstrated sensitivity to these drugs
Patients who are immunocompromised
Patients with significant hepatic or renal insufficiency, or any significant hematologic disorder
History of illicit alcohol or drug abuse within one year

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
Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeksAlso: LyricaFirst 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days and treat for 7 weeks. Followed by open label pregabalin for 4 weeks at 150 mg BID	Drug	Look alike placebo 150 or 300 mg daily for severe abdominal pain from adhesions, Pregabalin 150 or 300 mg daily for severe abdominal pain from adhesions
Placebo first followed by open label pregabalinAlso: Look alike placebo followed by open label pregabalin, LyricaLook alike placebo 75 mg po BID and increase to 150 mg BID after 3 days if no improvement for 7 weeks. Open label pregabalin 150 mg BID for last 4 weeks of study.	Drug	Look alike placebo 150 or 300 mg daily for severe abdominal pain from adhesions

Primary outcome

Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo
Time frame: Baseline and week 2 through week 12
Patients were randomized to pregabalin or placebo 75 mg twice a day. Patients were allowed to double the dose on day 3 if adequate pain relief was not obtained. Abdominal pain reduction was measured on a Likert scale. A Likert scale assumes the intensity of pain is linear on a continuum from no pain at level 0 to severe pain at level 10. Patients were required to complete a daily dairy recording pain using the Likert 11-point numeric scale. The primary end point was a positive change in the daily pain diary of 2 points from each patient's baseline at weeks 8 after the completion of the blinded study and at week 12 during the open label portion of the study. After 7 weeks all patients are randomized to study drug pregabalin 150 to 300 mg daily for 4 additional weeks after a one week wash out with no medication.

1 secondary outcome

Improved Sleep Scores
Time frame: Baseline and week 2 through week 12

Results and safety

Results posted to the registry on 23 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Drug	11	8
Placebo	7	5

Primary outcome: Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo

Time frame: Baseline and week 2 through week 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Patients Treated With Placebo n = 7	Patients Treated With Pregabalin n = 11
baseline pain score	5.8 (0.96)	6.15 (0.72)
week 2	5.22 (2.29)	2.87 (2.28)
week 3	4.64 (1.66)	1.88 (1.0)
week 4	4.84 (1.28)	3.31 (2.60)
week 5	4.32 (1.57)	2.72 (2.05)
week 6	3.88 (1.82)	2.49 (1.7)
week 7	3.92 (1.76)	2.53 (2.19)
week 8 open label with no study medication	4.13 (0.51)	2.46 (2.36)

Patients Treated With Placebo vs Patients Treated With Pregabalin: Mean Difference (Net): 2.0 (95% CI 0.0 to 4.0), p <0.05, ANOVA

Population analysed: The number of patients required per treatment group to achieve greater tha 80% power with alpha=0.05 were based on rates from published articles. The study was terminated early due to low enrollment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Drug 150 mg Double-blind and 300 mg Open-label	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Active Drug 300mg Double-blind and 300mg Open-label	1 of 6 (16.7%)	3 of 6 (50%)	0 of 6
Placebo (150 mg or 300mg): Double-Blind	0 of 7 (0%)	2 of 7 (28.6%)	0 of 7
Placebo (300 mg Active Drug): Open-label Only	0 of 5 (0%)	1 of 5 (20%)	0 of 5

Limitations and caveats (from the sponsor): Difficult to find patients that met criteria for study entry. Study terminated due to low enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22020082Silverman A, Samuels Q, Gikas H, Nawras A. Pregabalin for the treatment of abdominal adhesion pain: a randomized, double-blind, placebo-controlled trial. Am J Ther. 2012 Nov;19(6):419-28. doi: 10.1097/MJT.0b013e318217a5f5.

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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.

Ann L Silverman, MD principal investigator

Henry Ford Health System

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

Questions about this trial

What is this clinical trial studying?

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 7 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: stopped early, as of the sponsor's last update on 23 Oct 2023. 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 23 Oct 2023). 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?

Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo (time frame: Baseline and week 2 through week 12). 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 NCT00310765, which also lists 1 linked publication.

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 23 Oct 2023.