HealthyPhase 4NCT01094808
Pregabalin and Colonic Function
A Phase 4 study testing Pregabalin and Bowel preparation in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to evaluate the effects of pregabalin, a drug approved for anticonvulsive therapy and for neuropathic pain, on colonic and sensory functions in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pregabalin and Bowel preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Feb 2011
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males or females
Who cannot join
- Abdominal surgery other than appendectomy, laparoscopic cholecystectomy, cesarean section, vaginal or laparoscopic hysterectomy or tubal ligation
- A history of chronic gastrointestinal or systemic illnesses that could affect gastrointestinal motility
- Any history of hypertension
- Use of medications that may alter gastrointestinal motility or interact with the study medications
- Use of any of the study medications within the past 30 days
- Pregnancy
- Chronic renal insufficiency (serum creatinine >1.5 mg/dL)
- Psychiatric or psychologic dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pregabalin on Colonic Sensorimotor Function in Healthy Adults.
This study is being done to evaluate the effects of pregabalin, a drug approved for anticonvulsive therapy and for neuropathic pain, on colonic and sensory functions in healthy individuals.
The specific study hypotheses were as follows: 1) pregabalin increases sensation thresholds, decreases sensation ratings, and increases compliance in response to balloon distension in the colon; 2) pregabalin reduces colonic phasic and tonic motility in response to a standardized meal; and 3) sensation ratings are lower with higher colonic compliance.
Read the detailed description
The treatment of patients with irritable bowel syndrome and chronic abdominal pain is advancing with several effective options for symptoms related to bowel dysfunction and bloating/distension. However, there are no approved or effective centrally or peripherally acting visceral analgesics. Pregabalin has been proposed as a treatment for visceral pain, based on the pharmacological actions, and efficacy in neuropathic pain.
This was a trial of healthy adults to compare the effects of oral pregabalin, 75 mg and 200 mg versus placebo on sensation and contraction of the colon using validated methods.
All participants presented on the study day after an overnight bowel preparation with an oral colonic lavage solution and a 12-hour fast. Flexible colonoscopy to the splenic flexure was performed without sedation by one investigator. The barostat catheter (constructed at Mayo Clinic, Rochester, MN) incorporating six manometric point sensors 5 cm apart was introduced into the colon over a guidewire, and the polyethylene balloon (10 cm long, cylindrical shape with a maximum volume of 600 ml) was placed in the mid-descending or junction of the sigmoid and descending colon. A rigid-piston barostat was used to measure intraballoon pressure and volume throughout the study. After an initial inflation to a volume of 75 ml to ensure unfolding of the balloon, the operating pressure was identified as the distension pressure at which respiratory excursions were recorded clearly from the barostat tracing, and the intraballoon pressure was set 2 mm Hg above the minimal distension pressure. A conditioning distention from 0 to 36 mm Hg in increments of 4 mm Hg every 15 seconds was performed over a period of 3 minutes.
After an equilibration period of 10 minutes, colonic compliance was assessed by the ascending methods of limit (ramp-like increases of 4 mm Hg at 30 section intervals). During the assessment of colonic compliance, participants reported their thresholds for first perception, gas and pain. After another 10 minute equilibration period, fasting colonic tone was measured at operating pressure for a period of 10 minutes.
Randomized-order phasic distentions were then applied at 16, 24, 30, and 36 mm Hg above the operating pressure to measure the sensations of gas and pain. Each distention lasted 1 minute and was followed by an equilibration period at the operating pressure for 2 minutes. A 100-mm visual analog scale (VAS) was used to assess the rating of arousal and stress experienced by each participant before performing the phasic distentions. During the distentions, participants also used the 100-mm VAS to rate the intensity of gas and pain perception at 30 seconds from the start of the distention.
Colonic compliance, fasting tone, pressure thresholds for first perception, gas, and pain, and VAS scores of gas and pain during the phasic distentions were measured before administering the study medication and 1 hour after drug administration. After the postdrug assessment of sensation with phasic distentions, a 30-min assessment of fasting colonic tone was measured in each participant; this provided a baseline to compare the effect of a standard 750-ml chocolate milkshake meal across treatment groups. Postprandial tone was measured over 60 minutes, with the main focus on the first 30 minutes. When the recording was completed, the balloon was deflated and the tube removed by gentle traction.
- Conditions
- Healthy
- Being tested
- Pregabalin, Placebo, Bowel preparation
- Keywords
- pregabalin, motor, sensation, colon, pain, gas
- Medical subject headings
- Pain, Mucopolysaccharidosis IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
FDA approved medication (capsules) at 75 mg and 200 mg doses
PlaceboDrug
Placebo capsules
Bowel preparationOther
Also called GoLYTELY
Polyethylene glycol electrolyte solution bowel preparation
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin 75 mg | Experimental | Subjects randomized to this arm received a single dose of pregabalin 75 mg orally Receives: Drug: Pregabalin; Other: Bowel preparation |
| Pregabalin 200 mg | Experimental | Subjects randomized to this arm received a single dose of pregabalin 200 mg orally Receives: Drug: Pregabalin; Other: Bowel preparation |
| Placebo | Placebo comparator | Subjects randomized to this arm received a single dose of placebo medication orally Receives: Drug: Placebo; Other: Bowel preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Threshold for Pain
The sensory threshold for first perception of pain was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.
Measured: approximately 60 minutes after drug administration
Sensation Ratings for Pain and Gas at 30 mm Hg Distension Above Baseline Operating Pressure
The 30 mm Hg distension refers to inflation of the balloon placed in placed in the mid-descending or junction of the sigmoid and descending colon. Pain and gas were individually measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of either pain or gas.
Measured: Approximately 60 minutes after drug administration
Colonic Compliance
Colonic compliance is a measure of the "stiffness" of the colon, that is, what pressure was needed to reach half the maximum value of the colon. After the barostat balloon catheter was inserted in the mid-descending or junction of the sigmoid and descending colon, the balloon was inflated. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance.
Measured: Approximately 60 minutes after drug administration
Postprandial Colonic Tone [Reported] as the Symmetric Percent [Change]in Baseline Colonic Barostat Balloon Volume
The symmetric percent reduction in baseline colonic barostat balloon volume during the first 30 minutes postprandially (PP) corrected for the preprandial (30 min) tone, (symmetric percent change= 100*log_e[fasting/PP]). A positive symmetric percent change reflects a decrease in barostat balloon volume indicating a reduction in colonic tone. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.)
Measured: The first 30 minutes postprandially, and preprandial (30 minutes)
Postprandial Motility Index Over 30 Minutes
The first 30 minute postprandial motility index (MI), MI = log_e [(number of contractions * sum of amplitudes)+1]
Measured: 30 minutes after the meal
Secondary outcomes (5)
Sensory Threshold for Gas
The sensory threshold for first perception of gas was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.) During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation.
Measured: Approximately 60 minutes after drug administration
Sensation Ratings for Pain at 16, 24, and 36 mm Hg Distension
The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.
Measured: Approximately 60 minutes after drug administration
Sensation Ratings for Gas at 16, 24, and 36 mm Hg Distension
The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of either pain or gas.
Measured: Approximately 60 minutes after drug administration
Gas Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg)
The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of gas. The values across the 4 distension pressures were averaged for this outcome measure.
Measured: Approximately 60 minutes after drug administration
Pain Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg)
The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. The values across the 4 distension pressures were averaged for this outcome measure.
Measured: Approximately 60 minutes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2011
- Study completionFeb 2011
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 (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR)
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094808
- Sponsor's protocol ID
- 09-008469
- Other IDs
- 1RC1DK086182, R01DK079866, R01DK067071, UL1RR024150
- Status last verified
- Mar 2012
- First submitted
- 24 Mar 2010
- Last updated
- 7 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Iturrino J, Camilleri M, Busciglio I, Burton D, Zinsmeister AR. Effect of the alpha2delta ligand, pregabalin, on colonic sensory and motor functions in healthy adults. Am J Physiol Gastrointest Liver Physiol. 2011 Aug;301(2):G377-84. doi: 10.1152/ajpgi.00085.2011. Epub 2011 May 19.
PubMed 21596994Iturrino J, Camilleri M, Busciglio I, Burton D, Zinsmeister AR. Sensations of gas and pain and their relationship with compliance during distension in human colon. Neurogastroenterol Motil. 2012 Jul;24(7):646-51, e275. doi: 10.1111/j.1365-2982.2012.01901.x. Epub 2012 Mar 6.
PubMed 22393902
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pregabalin on Colonic Sensorimotor Function in Healthy Adults.
- ClinicalTrials.gov ID
- NCT01094808
- Acronym / sponsor ID
- 09-008469
- Conditions
- Healthy
- Keywords
- pregabalin, motor, sensation, colon, pain, gas
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR)
- Study start
- Mar 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 29 Mar 2010 (estimated)
- Results
- Posted 6 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to evaluate the effects of pregabalin, a drug approved for anticonvulsive therapy and for neuropathic pain, on colonic and sensory functions in healthy individuals.
The specific study hypotheses were as follows: 1) pregabalin increases sensation thresholds, decreases sensation ratings, and increases compliance in response to balloon distension in the colon; 2) pregabalin reduces colonic phasic and tonic motility in response to a standardized meal; and 3) sensation ratings are lower with higher colonic compliance.
Detailed description
The treatment of patients with irritable bowel syndrome and chronic abdominal pain is advancing with several effective options for symptoms related to bowel dysfunction and bloating/distension. However, there are no approved or effective centrally or peripherally acting visceral analgesics. Pregabalin has been proposed as a treatment for visceral pain, based on the pharmacological actions, and efficacy in neuropathic pain.
This was a trial of healthy adults to compare the effects of oral pregabalin, 75 mg and 200 mg versus placebo on sensation and contraction of the colon using validated methods.
All participants presented on the study day after an overnight bowel preparation with an oral colonic lavage solution and a 12-hour fast. Flexible colonoscopy to the splenic flexure was performed without sedation by one investigator. The barostat catheter (constructed at Mayo Clinic, Rochester, MN) incorporating six manometric point sensors 5 cm apart was introduced into the colon over a guidewire, and the polyethylene balloon (10 cm long, cylindrical shape with a maximum volume of 600 ml) was placed in the mid-descending or junction of the sigmoid and descending colon. A rigid-piston barostat was used to measure intraballoon pressure and volume throughout the study. After an initial inflation to a volume of 75 ml to ensure unfolding of the balloon, the operating pressure was identified as the distension pressure at which respiratory excursions were recorded clearly from the barostat tracing, and the intraballoon pressure was set 2 mm Hg above the minimal distension pressure. A conditioning distention from 0 to 36 mm Hg in increments of 4 mm Hg every 15 seconds was performed over a period of 3 minutes.
After an equilibration period of 10 minutes, colonic compliance was assessed by the ascending methods of limit (ramp-like increases of 4 mm Hg at 30 section intervals). During the assessment of colonic compliance, participants reported their thresholds for first perception, gas and pain. After another 10 minute equilibration period, fasting colonic tone was measured at operating pressure for a period of 10 minutes.
Randomized-order phasic distentions were then applied at 16, 24, 30, and 36 mm Hg above the operating pressure to measure the sensations of gas and pain. Each distention lasted 1 minute and was followed by an equilibration period at the operating pressure for 2 minutes. A 100-mm visual analog scale (VAS) was used to assess the rating of arousal and stress experienced by each participant before performing the phasic distentions. During the distentions, participants also used the 100-mm VAS to rate the intensity of gas and pain perception at 30 seconds from the start of the distention.
Colonic compliance, fasting tone, pressure thresholds for first perception, gas, and pain, and VAS scores of gas and pain during the phasic distentions were measured before administering the study medication and 1 hour after drug administration. After the postdrug assessment of sensation with phasic distentions, a 30-min assessment of fasting colonic tone was measured in each participant; this provided a baseline to compare the effect of a standard 750-ml chocolate milkshake meal across treatment groups. Postprandial tone was measured over 60 minutes, with the main focus on the first 30 minutes. When the recording was completed, the balloon was deflated and the tube removed by gentle traction.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregabalin 75 mg | Experimental | Drug: Pregabalin, Other: Bowel preparationSubjects randomized to this arm received a single dose of pregabalin 75 mg orally |
| Pregabalin 200 mg | Experimental | Drug: Pregabalin, Other: Bowel preparationSubjects randomized to this arm received a single dose of pregabalin 200 mg orally |
| Placebo | Placebo comparator | Drug: Placebo, Other: Bowel preparationSubjects randomized to this arm received a single dose of placebo medication orally |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy males or females
Key exclusion criteria (8 listed)
- Abdominal surgery other than appendectomy, laparoscopic cholecystectomy, cesarean section, vaginal or laparoscopic hysterectomy or tubal ligation
- A history of chronic gastrointestinal or systemic illnesses that could affect gastrointestinal motility
- Any history of hypertension
- Use of medications that may alter gastrointestinal motility or interact with the study medications
- Use of any of the study medications within the past 30 days
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 |
|---|---|---|
| PregabalinAlso: LyricaFDA approved medication (capsules) at 75 mg and 200 mg doses | Drug | Pregabalin 200 mg, Pregabalin 75 mg |
| PlaceboPlacebo capsules | Drug | Placebo |
| Bowel preparationAlso: GoLYTELYPolyethylene glycol electrolyte solution bowel preparation | Other | Placebo, Pregabalin 200 mg, Pregabalin 75 mg |
Primary outcome
Sensory Threshold for Pain
Time frame: approximately 60 minutes after drug administration
The sensory threshold for first perception of pain was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.
Sensation Ratings for Pain and Gas at 30 mm Hg Distension Above Baseline Operating Pressure
Time frame: Approximately 60 minutes after drug administration
The 30 mm Hg distension refers to inflation of the balloon placed in placed in the mid-descending or junction of the sigmoid and descending colon. Pain and gas were individually measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of either pain or gas.
Colonic Compliance
Time frame: Approximately 60 minutes after drug administration
Colonic compliance is a measure of the "stiffness" of the colon, that is, what pressure was needed to reach half the maximum value of the colon. After the barostat balloon catheter was inserted in the mid-descending or junction of the sigmoid and descending colon, the balloon was inflated. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance.
Postprandial Colonic Tone [Reported] as the Symmetric Percent [Change]in Baseline Colonic Barostat Balloon Volume
Time frame: The first 30 minutes postprandially, and preprandial (30 minutes)
The symmetric percent reduction in baseline colonic barostat balloon volume during the first 30 minutes postprandially (PP) corrected for the preprandial (30 min) tone, (symmetric percent change= 100*log_e[fasting/PP]). A positive symmetric percent change reflects a decrease in barostat balloon volume indicating a reduction in colonic tone. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.)
Postprandial Motility Index Over 30 Minutes
Time frame: 30 minutes after the meal
The first 30 minute postprandial motility index (MI), MI = log_e [(number of contractions * sum of amplitudes)+1]
5 secondary outcomes
Sensory Threshold for Gas
Time frame: Approximately 60 minutes after drug administration
Sensation Ratings for Pain at 16, 24, and 36 mm Hg Distension
Time frame: Approximately 60 minutes after drug administration
Sensation Ratings for Gas at 16, 24, and 36 mm Hg Distension
Time frame: Approximately 60 minutes after drug administration
Gas Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg)
Time frame: Approximately 60 minutes after drug administration
Pain Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg)
Time frame: Approximately 60 minutes after drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21596994Iturrino J, Camilleri M, Busciglio I, Burton D, Zinsmeister AR. Effect of the alpha2delta ligand, pregabalin, on colonic sensory and motor functions in healthy adults. Am J Physiol Gastrointest Liver Physiol. 2011 Aug;301(2):G377-84. doi: 10.1152/ajpgi.00085.2011. Epub 2011 May 19.
- Derived from this study: PubMed 22393902Iturrino J, Camilleri M, Busciglio I, Burton D, Zinsmeister AR. Sensations of gas and pain and their relationship with compliance during distension in human colon. Neurogastroenterol Motil. 2012 Jul;24(7):646-51, e275. doi: 10.1111/j.1365-2982.2012.01901.x. Epub 2012 Mar 6.
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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.
Michael Camilleri, MD principal investigator
Mayo Clinic
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 Pregabalin and Bowel preparation in people with Healthy, run by Mayo Clinic 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 1 inclusion and 8 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 7 Mar 2012. 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 6 Mar 2012). 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?
Sensory Threshold for Pain (time frame: approximately 60 minutes after drug administration). The study lists 5 primary outcomes in all. 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 NCT01094808, which also lists 2 linked publications.
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 7 Mar 2012.