Scorpion EnvenomationPhase 3NCT00753064
AScVS and/ or Prazosin for Scorpion Envenomation
A Phase 3 study testing Antiscorpion venom serum(AScVS)., T.Prazosin and AScVS + Prazosin in people with Scorpion Envenomation, run by Haffkine Bio-Pharmaceutical Corporation Ltd. at 5 sites in India.
Trial summary
The data available for the efficacy of AScVS and prazosin is generated through different trials done in different clinical setting. Hence it was felt worthwhile to confirm the documented efficacy of AScVS and prazosin in terms of time taken for clinical recovery in a clinical trial. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Scorpion Envenomation
- What is being tested?
- Antiscorpion venom serum(AScVS)., T.Prazosin and AScVS + Prazosin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 5 sitesIndia
- Study dates
- Sep 2006to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of both sexes, in the age range of 12-65 years
- reporting to the PHC/ hospital within 48 hours of scorpion sting and
- associated with s/s of scorpion envenomation having composite score between 5 and 21 (as computed based on the criteria below:)
- Criteria Grade Symptoms
- Sweating 0 Limited to the extremity of the sting site.
- Minimal sweating all over the body, slight nasal secretions
Show all 34Show fewer
- Generalized sweating with rigors and cold extremities.
- Gen.profuse sweating,wetting of clothes and cold clammy skin.
- Pulse rate 0 70- 90
- 91 - 100
- 101 - 120 or < 70
- 121 - 140 or < 60 or irreg pulse
- 141 - 160
- > 160
- Respiratory rate 0 < 20
- 20 - 30
- 31 - 40 without crepitations
- 31 - 40 with crepitations
- > 40 with crepitations
- > 40 with crepitations and cyanosis
- Blood pressure 0 120/80
- Systolic: 121 -140 and diastolic: 81 -90
- Systolic: 141 -160 and diastolic: 91-100
- Syst: 161 -180 and diast: 101-110 Or syst <100
- Syst: 181 -200 and diast: 111-120 Or syst <100
- Syst: > 200 and diast: >120 Or syst < 60
- CNS effects 0 No sensory involvement
- Minimal tingling numbness around mouth
- Tingling, numbness around mouth and giddiness
- Altered sensorium, patient roudy
- Patient semiconscious
- Patient unconscious
- Priapism 2 Slight erection 3 Strong erection
- To obtain a composite score, grades for individual criterion will be added. Maximum score: 25 and minimum score: 0
Who cannot join
- Composite score less than 5 and greater than 21.
- Grade of 5 in any of the criterion
- Severe Pulmonary edema with oxygen saturation below 80%.
- Severe scorpion envenomation with reporting time more than 2 days
- Any other serious medical disease which/treatment of which may confound the results e.g. cardiac diseases, diabetes, renal diseases etc.
- Severe anaphylactic reaction to any of the study drugs
- Patient (or relative in case of child) not willing to participate
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Kushte Hospital
Chiplūn, Maharashtra, 415605
Natu Hospital
Chiplūn, Maharashtra, 415605
Sane Hospital
Chiplūn, Maharashtra, 415605
Mangaon cottage hospital, Mangaon.
Dist. Raigad., Maharashtra, 402104
Vijayshree Hospital,At & Po.Umroli,Tal. Chiplun.
Dist. Ratnagiri., Maharashtra, 415702
About this study
Official title: Comparative Study of Efficacy of Antiscorpion Venom Serum(AScVS)vs Prazosin in the Management of Severe Scorpion(Mesobuthus Tamulus Concanesis Pocock)Envenomation and Evaluation of Effects of the Combination of AScVS + Prazosin Therapy.
The data available for the efficacy of AScVS and prazosin is generated through different trials done in different clinical setting. Hence it was felt worthwhile to confirm the documented efficacy of AScVS and prazosin in terms of time taken for clinical recovery in a clinical trial. Along with this, effects of both the therapies on various biochemical parameters will be recorded and compared with. It was also felt necessary to study the effect of combination on the clinical outcome.
Read the detailed description
Red Scorpion (Mesobuthus Tamulus Concanesis Pocock) sting is a common medical emergency in the coastal regions of India and is a cause for considerable morbidity and mortality.
Signs and symptoms show either cholinergic or adrenergic predominance. Cholinergic symptoms are profuse sweating, priapism, bradycardia, increased salivary and bronchial secretions and vomiting. Adrenergic symptoms are transient hypertension followed by hypotension, tachycardia, tachypnoea, pulmonary edema and circulatory failure in later stages. Scorpion venom blocks voltage dependent inactivation of sodium channels, resulting in intense persistent voltage depolarization of autonomic nerves with massive release of catecholamines from adrenal medulla and parasympathetic and sympathetic nerve endings.
Prazosin a selective alpha-1 blocker is used as the treatment for scorpion sting, which can only counteract the manifestations of sympathetic over-activity. Experimentally and clinically it is seen that scorpion venom stays in the body for 24-36 hours, as Prazosin does not neutralize the venom, 3 hourly round the clock doses of prazosin and continuous I.C.U. monitoring is necessary with alpha blocker therapy. However, ideal treatment modality remains neutralization of venom in the systemic circulation.
Since 1997 enzyme refined AScVS ( Monovalent Anti-scorpion venom serum against Mesobuthus tamulus concanesis Pocock.) has been made available by Haffkine Biopharmaceuticals, Mumbai for field use. Throughout the konkan(western coastal Maharashtra, India) area the same species of scorpions responsible for fatal envenomation is found.
From 1997-2002, 48 patients of serious scorpion envenomation were treated with AScVS(1). Based on this experience a clinical scoring system for dose requirement was evolved based on sweating, pulse rate, respiratory rate, blood pressure, CNS effects and presence of priapism. In our experience computed doses given as intravenous bolus are more effective and successfully ameliorated signs and symptoms in all patients. Subsequently 16 patients were given treatment with either AScVS (n=8), Prazosin (n=5) and a combination of both (n=3) so as to compare the effects of these available treatment modalities. It was found that the patients receiving either AScVs or a combination showed a complete recovery approximately within 4 hours of onset of therapy as against patients receiving Prazosin, who required 16 hours for recovery. There was no mortality in any of the group. There was not a single incidence of anaphylaxis after administration of AScVS. Release of adrenaline in the systemic circulation by scorpion sting itself appears to be protective against the danger of anaphylaxis. The label on the AScVS vials states that the maximum dose is 3 vials, which can be given either intramuscular or by intravenous route. However we used AScVS as slow bolus intravenously and dose was decided clinically depending upon the severity of the patient condition. (maximum 10-15vials.) Based on this experience, an open labeled, randomized controlled parallel group clinical trial has been initiated. Eighty-three patients have been recruited so far, 28 patients each, in AScVS and AScVS + prazosin group and 27 patients in Prazosin group, two patients out of 27 in Prazosin group were withdrawn as both the pediatric patients (around 12 years old) developed pulmonary edema after few hours, so AScVS had to be given. The onset of relief (based on composite score) with AScVS or combination of AScVS with prazosin was early and complete recovery occurred at 4.14+/- 1.6 hrs. and 3.46+/- 1.10hours. However, in patients receiving only prazosin, the clinical score was found to worsen initially, followed by a gradual improvement and subsequent complete recovery, at 19.28 +/- 5.03 hrs. (p<0.001 vs AScVS). Recovery time with AScVS is much shorter because after complete neutralization of venom, fresh secretion of catecholamines stop and adrenaline and nor-adrenaline which are already in circulation have action as short as 1 to 2 minutes. These findings appear consistent with our clinical experience and indicate that in the near future AScVS would evolve as a safe, efficacious and life saving treatment modality for patients with severe scorpion envenomation. Use of clinical scoring system can enable the clinician to select the optimum dose of AScVS to be administered.
Neutralization of venom is thus proved to be better than therapy for complications, akin to the dictum 'prevention is better than cure'.
References:
- Natu VS, Murthy RKK, Deodhar KP. Efficacy of species specific Antiscorpion venom serum (AScVS) against severe, serious scorpion stings (mesobuthus tamulus concanesis pocock.)-An experience from rural hospital in western Maharashtra. JAPI, 2006; 54: 283-7.
- Conditions
- Scorpion Envenomation
- Being tested
- Antiscorpion venom serum(AScVS)., T.Prazosin, AScVS + Prazosin
- Keywords
- Red Scorpion envenomation, Composite clinical scoring system, AScVS, Prazosin, Superiority
- Medical subject headings
- Scorpion Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiscorpion venom serum(AScVS).Drug
Also called AScVS(Haffkine)
AScVS therapy group
If the score is 5 and if the patient belongs to pediatric group(>12-14): 1 vial AScVS as i.v. slow bolus after test dose If the score is 5 and if the patient is adult: 2 vials of AScVS as i.v. slow bolus after test dose. For injection, 1 vial will be dissolved in 10 ml distilled water and given over a period of 4 to 5 minutes.
According to the scores 1 vial for pediatric and 2 vials for adult patient will be increased as shown below:
Vials of AScVS Composite score Child Adult 5-10 2 4 > 10-15 3 6 >15- 21 4 8
T.PrazosinDrug
Also called T.Prazosin (sun pharma)
Prazosin therapy Prazosin (30 micrograms/Kg/dose): 500 micrograms for pediatric patient, and 1mg for adult patients) will be given every 3 hourly orally till complete recovery.
AScVS + PrazosinDrug
Also called AScVS (Haffkine), T. Prazosin (sun pharma)
Combination AScVS and Prazosin therapy In this group, AScVS therapy will be given as mentioned in AScVS therapy group and in addition, prazosin(500 micrograms for pediatric patient and 1mg for adult patients,30 micrograms/Kg/dose) every 3 hourly will be given.
| Study group | Role | What they receive |
|---|---|---|
| AScVS | Active comparator | a clinical scoring system for dose requirement for AScVS is evolved based on sweating, pulse rate, respiratory rate, blood pressure, CNS effects and presence of priapism. Computed doses were given according to clinical grading as intravenous bolus slowly. Receives: Drug: Antiscorpion venom serum(AScVS). |
| Prazosin. | Active comparator | Prazosin therapy Prazosin (30 micrograms/Kg/dose): 500 micrograms for pediatric patient, and 1mg for adult patients) will be given every 3 hourly orally till complete recovery. Receives: Drug: T.Prazosin |
| AScVS + Prazosin | Active comparator | Combination AScVS and Prazosin therapy In this group, AScVS therapy will be given as mentioned in AScVS therapy group and in addition, prazosin (500 micrograms for pediatric patient and 1mg for adult patients,30 micrograms/Kg/dose) every 3 hourly will be given. Receives: Drug: AScVS + Prazosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority of AScVS and AScVS+Prazosin was confirmed over use of Prazosin alone.
Measured: 1year 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startSep 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scorpion EnvenomationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haffkine Bio-Pharmaceutical Corporation Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr Vivek S Natu, M.S., Principal investigator, Vijayshree Hospital, Umroli, Chiplun, Ratnagiri, Maharashtra, India.Dr. Santosh Kamerkar, M.S, Study chair, Cottage Hospital Mangaon,Raigad,Maharashtra, IndiaDr. Geeta Kadam, M.B.B.S., Study chair, Cottage Hospital Mangaon,Raigad,Maharashtra, IndiaDr. Vidya Kamble, M.B.B.S., Study chair, Cottage Hospital Mangaon,Raigad,Maharashtra, IndiaDr. Vikas Natu, MBBS DCH, Study chair, Natu Hospital Chiplun,Ratnagiri, Maharashtra,IndiaDr. Sanjeev Sane, MBBS DCH, Study chair, Sane Hospital Chiplun,Ratnagiri, Maharashtra,IndiaDr. Rajesh Kushte, MBBSDCH, Study chair, Kushte Hospital Chiplun,Ratnagiri, Maharashtra,IndiaDr. Sunil Thatte, M.D., Study chair, Attending physician at Natu, Sane & Kushte Hospital Chiplun,Ratnagiri, Maharashtra,India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753064
- Sponsor's protocol ID
- AScVS vs Prazosin
- Status last verified
- Sep 2008
- First submitted
- 14 Sep 2008
- Last updated
- 16 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Efficacy of Antiscorpion Venom Serum(AScVS)vs Prazosin in the Management of Severe Scorpion(Mesobuthus Tamulus Concanesis Pocock)Envenomation and Evaluation of Effects of the Combination of AScVS + Prazosin Therapy.
- ClinicalTrials.gov ID
- NCT00753064
- Acronym / sponsor ID
- AScVS vs Prazosin
- Conditions
- Scorpion Envenomation
- Keywords
- Red Scorpion envenomation, Composite clinical scoring system, AScVS, Prazosin, Superiority
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Haffkine Bio-Pharmaceutical Corporation Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 16 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The data available for the efficacy of AScVS and prazosin is generated through different trials done in different clinical setting. Hence it was felt worthwhile to confirm the documented efficacy of AScVS and prazosin in terms of time taken for clinical recovery in a clinical trial. Along with this, effects of both the therapies on various biochemical parameters will be recorded and compared with. It was also felt necessary to study the effect of combination on the clinical outcome.
Detailed description
Red Scorpion (Mesobuthus Tamulus Concanesis Pocock) sting is a common medical emergency in the coastal regions of India and is a cause for considerable morbidity and mortality.
Signs and symptoms show either cholinergic or adrenergic predominance. Cholinergic symptoms are profuse sweating, priapism, bradycardia, increased salivary and bronchial secretions and vomiting. Adrenergic symptoms are transient hypertension followed by hypotension, tachycardia, tachypnoea, pulmonary edema and circulatory failure in later stages. Scorpion venom blocks voltage dependent inactivation of sodium channels, resulting in intense persistent voltage depolarization of autonomic nerves with massive release of catecholamines from adrenal medulla and parasympathetic and sympathetic nerve endings.
Prazosin a selective alpha-1 blocker is used as the treatment for scorpion sting, which can only counteract the manifestations of sympathetic over-activity. Experimentally and clinically it is seen that scorpion venom stays in the body for 24-36 hours, as Prazosin does not neutralize the venom, 3 hourly round the clock doses of prazosin and continuous I.C.U. monitoring is necessary with alpha blocker therapy. However, ideal treatment modality remains neutralization of venom in the systemic circulation.
Since 1997 enzyme refined AScVS ( Monovalent Anti-scorpion venom serum against Mesobuthus tamulus concanesis Pocock.) has been made available by Haffkine Biopharmaceuticals, Mumbai for field use. Throughout the konkan(western coastal Maharashtra, India) area the same species of scorpions responsible for fatal envenomation is found.
From 1997-2002, 48 patients of serious scorpion envenomation were treated with AScVS(1). Based on this experience a clinical scoring system for dose requirement was evolved based on sweating, pulse rate, respiratory rate, blood pressure, CNS effects and presence of priapism. In our experience computed doses given as intravenous bolus are more effective and successfully ameliorated signs and symptoms in all patients. Subsequently 16 patients were given treatment with either AScVS (n=8), Prazosin (n=5) and a combination of both (n=3) so as to compare the effects of these available treatment modalities. It was found that the patients receiving either AScVs or a combination showed a complete recovery approximately within 4 hours of onset of therapy as against patients receiving Prazosin, who required 16 hours for recovery. There was no mortality in any of the group. There was not a single incidence of anaphylaxis after administration of AScVS. Release of adrenaline in the systemic circulation by scorpion sting itself appears to be protective against the danger of anaphylaxis. The label on the AScVS vials states that the maximum dose is 3 vials, which can be given either intramuscular or by intravenous route. However we used AScVS as slow bolus intravenously and dose was decided clinically depending upon the severity of the patient condition. (maximum 10-15vials.) Based on this experience, an open labeled, randomized controlled parallel group clinical trial has been initiated. Eighty-three patients have been recruited so far, 28 patients each, in AScVS and AScVS + prazosin group and 27 patients in Prazosin group, two patients out of 27 in Prazosin group were withdrawn as both the pediatric patients (around 12 years old) developed pulmonary edema after few hours, so AScVS had to be given. The onset of relief (based on composite score) with AScVS or combination of AScVS with prazosin was early and complete recovery occurred at 4.14+/- 1.6 hrs. and 3.46+/- 1.10hours. However, in patients receiving only prazosin, the clinical score was found to worsen initially, followed by a gradual improvement and subsequent complete recovery, at 19.28 +/- 5.03 hrs. (p<0.001 vs AScVS). Recovery time with AScVS is much shorter because after complete neutralization of venom, fresh secretion of catecholamines stop and adrenaline and nor-adrenaline which are already in circulation have action as short as 1 to 2 minutes. These findings appear consistent with our clinical experience and indicate that in the near future AScVS would evolve as a safe, efficacious and life saving treatment modality for patients with severe scorpion envenomation. Use of clinical scoring system can enable the clinician to select the optimum dose of AScVS to be administered.
Neutralization of venom is thus proved to be better than therapy for complications, akin to the dictum 'prevention is better than cure'.
References:
- Natu VS, Murthy RKK, Deodhar KP. Efficacy of species specific Antiscorpion venom serum (AScVS) against severe, serious scorpion stings (mesobuthus tamulus concanesis pocock.)-An experience from rural hospital in western Maharashtra. JAPI, 2006; 54: 283-7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AScVS | Active comparator | Drug: Antiscorpion venom serum(AScVS).a clinical scoring system for dose requirement for AScVS is evolved based on sweating, pulse rate, respiratory rate, blood pressure, CNS effects and presence of priapism. Computed doses were given according to clinical grading as intravenous bolus slowly. |
| Prazosin. | Active comparator | Drug: T.PrazosinPrazosin therapy Prazosin (30 micrograms/Kg/dose): 500 micrograms for pediatric patient, and 1mg for adult patients) will be given every 3 hourly orally till complete recovery. |
| AScVS + Prazosin | Active comparator | Drug: AScVS + PrazosinCombination AScVS and Prazosin therapy In this group, AScVS therapy will be given as mentioned in AScVS therapy group and in addition, prazosin (500 micrograms for pediatric patient and 1mg for adult patients,30 micrograms/Kg/dose) every 3 hourly will be given. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (34 listed)
- Patients of both sexes, in the age range of 12-65 years
- reporting to the PHC/ hospital within 48 hours of scorpion sting and
- associated with s/s of scorpion envenomation having composite score between 5 and 21 (as computed based on the criteria below:)
- Criteria Grade Symptoms
- Sweating 0 Limited to the extremity of the sting site.
Key exclusion criteria (7 listed)
- Composite score less than 5 and greater than 21.
- Grade of 5 in any of the criterion
- Severe Pulmonary edema with oxygen saturation below 80%.
- Severe scorpion envenomation with reporting time more than 2 days
- Any other serious medical disease which/treatment of which may confound the results e.g. cardiac diseases, diabetes, renal diseases etc.
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 |
|---|---|---|
| Antiscorpion venom serum(AScVS).Also: AScVS(Haffkine)AScVS therapy group If the score is 5 and if the patient belongs to pediatric group(>12-14): 1 vial AScVS as i.v. slow bolus after test dose If the score is 5 and if the patient is adult: 2 vials of AScVS as i.v. slow bolus after test dose. For injection, 1 vial will be dissolved in 10 ml distilled water and given over a period of 4 to 5 minutes. According to the scores 1 vial for pediatric and 2 vials for adult patient will be increased as shown below: Vials of AScVS Composite score Child Adult 5-10 2 4 > 10-15 3 6 >15- 21 4 8 | Drug | AScVS |
| T.PrazosinAlso: T.Prazosin (sun pharma)Prazosin therapy Prazosin (30 micrograms/Kg/dose): 500 micrograms for pediatric patient, and 1mg for adult patients) will be given every 3 hourly orally till complete recovery. | Drug | Prazosin. |
| AScVS + PrazosinAlso: AScVS (Haffkine), T. Prazosin (sun pharma)Combination AScVS and Prazosin therapy In this group, AScVS therapy will be given as mentioned in AScVS therapy group and in addition, prazosin(500 micrograms for pediatric patient and 1mg for adult patients,30 micrograms/Kg/dose) every 3 hourly will be given. | Drug | AScVS + Prazosin |
Primary outcome
Superiority of AScVS and AScVS+Prazosin was confirmed over use of Prazosin alone.
Time frame: 1year 4 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2008.
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.
Dr Vivek S Natu, M.S. principal investigator
Vijayshree Hospital, Umroli, Chiplun, Ratnagiri, Maharashtra, India.
Dr. Santosh Kamerkar, M.S study chair
Cottage Hospital Mangaon,Raigad,Maharashtra, India
Dr. Geeta Kadam, M.B.B.S. study chair
Cottage Hospital Mangaon,Raigad,Maharashtra, India
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antiscorpion venom serum(AScVS)., T.Prazosin and AScVS + Prazosin in people with Scorpion Envenomation, run by Haffkine Bio-Pharmaceutical Corporation Ltd. at 5 sites in India.
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 34 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: finished, as of the sponsor's last update on 16 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Superiority of AScVS and AScVS+Prazosin was confirmed over use of Prazosin alone. (time frame: 1year 4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2008.