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Study was terminated by the sponsor due to low accrual.
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and week 2 through week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann L Silverman, MD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | West Bloomfield | Michigan | 48322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22020082 | Result | 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. |
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After signing consent patients completed a one week baseline pain and sleep evaluation. Patients completed a Short-Form McGill Pain Questionaire during screening and at randomization. Patients had an average daily diary score of at least 4 on the the Likert scale during the baseline week and 5 diary recordings with stable pain medication doses.
Study was performed between December 2005 and August 2008. Patients were referred to the gastroenterology clinic if they had documented adhesions in the last 5 years, negative pain evaluation and pain that was thought to be from adhesions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Drug | 75-150 mg of pregabalin po BID Pregabalin : First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg pregabalin and increase to 150 mg po BID if no improvement after 3 days |
| FG001 | Placebo | Placebo 75 or 150 mg po BID Pregabalin : 75 mg po BID Pregabalin : First 7 weeks 75 or 150 mg of placebo pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo Controlled Double Blind |
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| Open Label |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Drug | 75-150 mg of pregabalin po BID Pregabalin : 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and week 2 through week 12 |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Drug 150 mg Double-blind and 300 mg Open-label | Double-Blind: 75 mg of pregabalin po BID (Weeks1-7) Open-label:150 mg of pregabalin BID (Weeks 8-11) Pregabalin : 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | Non-systematic Assessment | 60 yo woman did not disclose a history of alcohol abuse. She attempted suicide with an overdose of pregabalin. History available from emergency Psychiatrist. Patient was hospitalized and refused further follow up. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache and hyperactivity | Nervous system disorders | Non-systematic Assessment |
Difficult to find patients that met criteria for study entry. Study terminated due to low enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ann Silverman | retired | anngimd@icloud.com |
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| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C494814 | BID protein, human |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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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.
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Double blinding was done to ensure minimum bias. Clinicians were not involved in the randomization process. Patients and clinicians were blinded to the identity of the drug as a look alike placebo was used. The randomization code was was maintained by the research assistant and kept in a locked file cabinet. Separated individuals generated the allocation sequence. The blind was maintained until all the decisions regarding data evaluability were made or in the event of a serious adverse event.
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| Placebo first followed by open label pregabalin | Drug | 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. |
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| Baseline and week 2 through week 12 |
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Placebo 75 or 150 mg po BID
Pregabalin : 75 mg po BID
Pregabalin : 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
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| ID | Title | Description |
|---|---|---|
| OG000 | Patients Treated With Placebo | Patients treated with look alike pregabalin placebo 75 or 150 mg BID for seven weeks followed by a week wash out and 150 mg BID of pregabalin |
| OG001 | Patients Treated With Pregabalin | Patients treated with pregabalin 75 or 150 mg po BID |
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| Secondary | 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 | Pregabalin patients received 150mg or 300 mg for seven weeks and placebo patients received a look alike placebo for seven weeks. All patients received open label 300 mg of placebo for 4 weeks after a one week wash out phase at week 8. | Posted | Mean | Standard Deviation | units on a scale | Baseline and week 2 through week 12 |
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| 0 |
| 5 |
| 0 |
| 5 |
| 3 |
| 5 |
| EG001 | Active Drug 300mg Double-blind and 300mg Open-label | Double blink:150 mg of pregabalin BID (Weeks 1-7) Open-label: 150 mg of pregabalin BID (Weeks 8-11) Pregabalin : 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 | 0 | 6 | 1 | 6 | 3 | 6 |
| EG002 | Placebo (150 mg or 300mg): Double-Blind | Double-blind: Placebo (150 or 300 mg) for weeks 1-7 only. | 0 | 7 | 0 | 7 | 2 | 7 |
| EG003 | Placebo (300 mg Active Drug): Open-label Only | Participants who received placebo during the Double-blind phase had the option to receive pregabalin 150 mg BID during the open-label phase for 4 weeks (Weeks 8-11 only). | 0 | 5 | 0 | 5 | 1 | 5 |
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| night sweats | Blood and lymphatic system disorders | Non-systematic Assessment |
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| dizziness | Ear and labyrinth disorders | Non-systematic Assessment |
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| drowsiness | General disorders | Non-systematic Assessment |
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| dizziness and blurred vision | Nervous system disorders | Non-systematic Assessment |
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| hand numbness | Nervous system disorders | Non-systematic Assessment |
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| gastroenteritis and dizziness | Metabolism and nutrition disorders | Non-systematic Assessment |
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| pedal edema | Blood and lymphatic system disorders | Non-systematic Assessment |
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| D012817 | Signs and Symptoms, Digestive |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| week 3 |
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| week 4 |
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| week 5 |
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| week 6 |
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| week 7 |
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| week 8 open label no study medication |
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| week 9 open label |
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| week 10 open label |
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| week 11 open label |
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| week 12 open label |
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