Irritable Bowel Syndrome
Conditions
Brief summary
This study is being done to see if Lyrica helps people with irritable bowel syndrome.
Detailed description
Lyrica is the trade name for pregabalin, which was first approved by the FDA in June 2005 and has been available through prescription since fall 2005, and is marketed by Pfizer. Lyrica is known to have clinical efficacy treating pain disorders including irritable bowel syndrome-related conditions such as fibromyalgia.
Interventions
DRUGPregabalin
Dose: 75 mg twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.
DRUGPlacebo
A matching placebo will be administered twice a day
Sponsors
Pfizer
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Established diagnosis of Irritable Bowel Syndrome (IBS) * Experience pain with relief with defecation * 50/100 or greater of pain or discomfort scores during the two-week baseline period * At least three pain attacks in a month, with at least three episodes of pain intensity equal to or exceeding 50/100 * U.S. resident * English-speaking (able to provide consent and complete questionnaires) * Able to participate in all aspects of the study
Exclusion criteria
* Known alternative/concurrent gastrointestinal diagnosis (e.g. Crohn's disease, ulcerative colitis, microscopic colitis, active celiac sprue, chronic pancreatitis or pancreatic insufficiency, scleroderma, chronic intestinal pseudo-obstruction, bacterial overgrowth, recent (\<6 months) intestinal bacterial/protozoal/ parasitic infections, HIV, active pelvic floor dysfunction, paraplegia or quadriplegia); * Current symptoms of severe depression, as measured by Hospital Anxiety and Depression Scale (HADS) score (greater or less than 15); * Mental retardation or any condition requiring a legal guardian; * Current or past history of psychotic disorder (schizophrenia, bipolar disorder) * Recent or current use (within past 30 days) of drugs that interact with Pregabalin: * Rosiglitazone (Avandia) or Pioglitazone (Actos) * Narcotic anti-pain medications (e.g. oxycodone, morphine) * Anti-anxiety medications (e.g. lorazepam, alprazolam, diazepam) * Unable to withdraw medications at least 72 hours prior to the study, because we will evaluate patient's response to pregabalin therapy for relief of IBS-associated pain and disturbed sleep. 1. Non-narcotic anti-pain medications (e.g. nonsteroidal antiinflammatory drug (NSAIDs), ultram, neurontin, etc.) 2. Mexiletine, steroids, dextromethorphan. 3. Insomnia medications (e.g. benzodiazepines, zolpidem, diphenhydramine, melatonin, etc.) * Planned surgery (especially transplant) or anesthesia exposure during trial * Are pregnant, lactating, likely to become pregnant during medication phase and not willing to use a reliable form of contraception (barrier contraceptives, diaphragm, injections, intrauterine device, surgical sterilization, or abstinence) * Recent or current use (within 30 days) of Pregabalin * Known allergy to Pregabalin * Significant acute or chronic progressive neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease * Recent history of alcohol or substance dependence use or abuse * Another household member or relative participating in the study * Professional drivers or operators of heavy machinery * Major cardiovascular events in the last 6 months * Use of IBS-specific drugs such as tegaserod (Zelnorm) and Lotronex (Alosetron) (within 30 days) * Participation in another clinical trial (within 30 days)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12) | weeks 9-12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12) | Weeks 9-12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. |
| Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) | Weeks 9-12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. |
| Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) | Weeks 9-12) | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. |
| Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy | Weeks 9-12 | One of the weekly questions asked of subjects was, Did you have adequate relief of your IBS symptoms over the last week? Possible answers were Yes or No. |
| Mean Pain BSS Score at Week 12 | Week 12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. |
| Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12) | weeks 9-12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. |
| Mean Constipation BSS Score at Week 12 | Week 12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. |
| Mean Diarrhea BSS Score at Week 12 | Week 12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. |
| Mean Bloating BSS Score at Week 12 | Week 12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. |
| Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score | baseline, week 12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. |
| Mean Overall Severity BSS Score at Week 12 | Week 12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Subjects randomized to this arm will receive the following dosage:
75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study. | 41 |
| Placebo Subjects randomized to this arm will receive placebo matching the study drug. | 44 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Nonadherence | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Pregabalin | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 40 Participants | 78 Participants |
| Number of Subjects with Fibromyalgia at Baseline Fibromyalgia - No | 31 participants | 37 participants | 68 participants |
| Number of Subjects with Fibromyalgia at Baseline Fibromyalgia - Yes | 10 participants | 7 participants | 17 participants |
| Region of Enrollment United States | 41 participants | 44 participants | 85 participants |
| Sex: Female, Male Female | 36 Participants | 37 Participants | 73 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / 41 | 24 / 44 |
| serious Total, serious adverse events | 1 / 41 | 0 / 44 |
Outcome results
Primary
Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12)
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time frame: weeks 9-12
Population: Intent to treat analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12) | 25.3 units on a scale | Standard Deviation 16 |
| Placebo | Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12) | 42.0 units on a scale | Standard Deviation 26.6 |
p-value: 0.008ANCOVA
Secondary
Mean Bloating BSS Score at Week 12
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time frame: Week 12
Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Bloating BSS Score at Week 12 | 26.3 units on a scale | Standard Deviation 24.4 |
| Placebo | Mean Bloating BSS Score at Week 12 | 45.0 units on a scale | Standard Deviation 32 |
p-value: 0.016ANCOVA
Secondary
Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time frame: Weeks 9-12)
Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) | 29.3 units on a scale | Standard Deviation 23.3 |
| Placebo | Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) | 43.6 units on a scale | Standard Deviation 29 |
p-value: 0.044ANCOVA
Secondary
Mean Constipation BSS Score at Week 12
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time frame: Week 12
Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Constipation BSS Score at Week 12 | 26.1 units on a scale | Standard Deviation 30.4 |
| Placebo | Mean Constipation BSS Score at Week 12 | 23.6 units on a scale | Standard Deviation 26.7 |
p-value: 0.417ANCOVA
Secondary
Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12)
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time frame: Weeks 9-12
Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12) | 25.8 units on a scale | Standard Deviation 26.8 |
| Placebo | Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12) | 22.4 units on a scale | Standard Deviation 24.8 |
p-value: 0.389ANCOVA
Secondary
Mean Diarrhea BSS Score at Week 12
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time frame: Week 12
Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Diarrhea BSS Score at Week 12 | 15.6 units on a scale | Standard Deviation 19.8 |
| Placebo | Mean Diarrhea BSS Score at Week 12 | 34.4 units on a scale | Standard Deviation 29.7 |
p-value: 0.03ANCOVA
Secondary
Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time frame: Weeks 9-12
Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) | 16.9 units on a scale | Standard Deviation 18.4 |
| Placebo | Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) | 31.8 units on a scale | Standard Deviation 25.8 |
p-value: 0.049ANCOVA
Secondary
Mean Overall Severity BSS Score at Week 12
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time frame: Week 12
Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Overall Severity BSS Score at Week 12 | 28.5 units on a scale | Standard Deviation 20.2 |
| Placebo | Mean Overall Severity BSS Score at Week 12 | 44.2 units on a scale | Standard Deviation 28.8 |
p-value: 0.024ANCOVA
Secondary
Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12)
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time frame: weeks 9-12
Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12) | 26.5 units on a scale | Standard Deviation 15.2 |
| Placebo | Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12) | 42.2 units on a scale | Standard Deviation 25.7 |
p-value: 0.009ANCOVA
Secondary
Mean Pain BSS Score at Week 12
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time frame: Week 12
Population: The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Mean Pain BSS Score at Week 12 | 26.1 units on a scale | Standard Deviation 18.8 |
| Placebo | Mean Pain BSS Score at Week 12 | 43.3 units on a scale | Standard Deviation 30 |
p-value: 0.02ANCOVA
Secondary
Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy
One of the weekly questions asked of subjects was, Did you have adequate relief of your IBS symptoms over the last week? Possible answers were Yes or No.
Time frame: Weeks 9-12
Population: Intent to treat analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy | Adequate Relief (Yes) | 19 participants |
| Pregabalin | Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy | Inadequate Relief (No) | 22 participants |
| Placebo | Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy | Inadequate Relief (No) | 28 participants |
| Placebo | Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy | Adequate Relief (Yes) | 16 participants |
p-value: 0.35Chi-squared
Secondary
Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.
Time frame: baseline, week 12
Population: Intent to Treat analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score | Yes, >= 30 point change | 26 participants |
| Pregabalin | Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score | No, >= 30 point change | 15 participants |
| Placebo | Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score | Yes, >= 30 point change | 20 participants |
| Placebo | Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score | No, >= 30 point change | 24 participants |
p-value: 0.097Chi-squared