Evaluation of Abuse Potential of SativexPhase 1NCT01323569
Abuse Potential of Sativex
A Phase 1 study testing Sativex and Marinol in people with Evaluation of Abuse Potential of Sativex, run by Jazz Pharmaceuticals at 1 site in Canada.
Trial summary
This crossover study with six treatment sessions is to evaluate the abuse potential of three doses of Sativex as compared to Marinol and placebo, in subjects with a history of recreational marijuana use. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluation of Abuse Potential of Sativex
- What is being tested?
- Sativex and Marinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to Jun 2008
- Phase
- Phase 1
- 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects, 19 to 45 years of age, inclusive.
- Current recreational marijuana users, defined as the use of smoked marijuana, hashish, or oral THC, at least once a week for the 3 months prior to screening and, on at least one occasion, four times in a given week in the 3 months prior to screening.
- Body mass index within the range of 19 to 30 kg/m2 inclusive and a minimum weight of at least 50 kg at screening.
- Free of any clinically significant abnormality, assessed at screening, on the basis of medical history, vital signs, physical examination, 12-lead ECG, and clinical laboratory tests, including haematology, clinical chemistry, urinalysis, and serology, as judged by the investigator or designee.
- A positive urine THC drug screen at screening and qualification, which was confirmed by quantitative analysis; the level must have been at least 50 ng of THC/mL.
- A negative urine drug screen for cocaine, opiates, amphetamine, and benzodiazepines upon admission to the screening, qualification session, or treatment sessions. Subjects who had a positive urine drug screen upon presentation to a study visit could have been rescheduled for another session at the discretion of the investigator.
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- All female subjects were required to have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to the qualification session and to each drug treatment session.
- Subjects with reproductive potential could be entered into the study if they had been using and were willing to continue to use two methods of contraception for the duration of the study. These methods included male condom for men in addition to an oral contraceptive, contraceptive implant or injection, intrauterine device, diaphragm, or a contraceptive sponge for women. Adequate protection, as defined above, had to have been used for at least 1 month prior to screening for all, with the exception of oral contraceptives, which should have been used for at least 3 months prior to screening. These methods had to be continually used for 30 days after the end of the study. Subjects that had been surgically sterilized (tubal ligation, hysterectomy, or vasectomy) or had been post-menopausal for at least 2 years (by history) were not considered to be of reproductive potential.
- Subjects had to pass a qualification session.
- Must have understood and provided written informed consent, prior to initiation of any protocol-specific procedures.
- Subjects were able to comply with study procedures.
- Negative breath alcohol test. Subjects who had a positive breath alcohol test could have been rescheduled at the discretion of the investigator.
Who cannot join
- History or presence of drug or alcohol dependence (excluding nicotine and caffeine), including subjects who had ever been in a drug rehabilitation program.
- Clinically important impairment or dysfunction of any body system, including, but not limited to, the following: cardiovascular, haematological, hepatic, gastrointestinal, renal, pulmonary, or neurological, as judged by the investigator or designee.
- Any known or suspected history (including family history) of schizophrenia or other psychotic illness. Presence or history of a psychiatric disorder, organic brain disorder, or seizure disorder that was deemed clinically significant by the investigator.
- History of hypersensitivity or allergy to cannabinoids, cannabis and/or its metabolites, to the study drug excipients, or to similar compounds (propylene glycol, ethanol, peppermint, and sesame oils) or allergic reactions to any other medication.
- Consumed caffeine-containing beverages in excess of 450 mg of caffeine (e.g. 5 cups of tea or 3 cups of regular coffee or 8 cans of cola) per day in the 6 months prior to screening.
- Consumed greater than 20 cigarettes per day.
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- Treatment with another investigational or non-approved drug, within 4 weeks prior to the start of qualification session dosing (Day 1).
- Donated or lost blood (>100 mL) within the 30 days prior to screening.
- Female subjects who were pregnant or lactating or who were planning to become pregnant within 60 days of last study drug administration.
- Used prescription drugs (except oral contraceptives or sex hormone replacement), including smoked THC for medicinal purposes, within 14 days of the qualification session and for the duration of the study, unless in the opinion of the investigator (or designee), the medication received would not interfere with the study procedures or data integrity or compromise the safety of the subject.
- Used non-prescription drugs or natural health products other than acetaminophen up to 2 g per day or vitamin or mineral supplements (including mega dose vitamin therapy), within 7 days prior to the qualification session, and for the duration of the study, unless in the opinion of the investigator (or designee), the medication received would not interfere with the study procedures or data integrity or compromise the safety of the subject.
- Uncontrolled hypertension at screening that was judged as clinically significant by the investigator (or designee).
- Subjects who, in the opinion of the investigator (or designee). were not willing, able or capable of following the study schedule for any reason.
- Subjects who were positive for or were being treated for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
- Subjects facing current or pending legal charges.
Trial locations and contacts
1 site in 1 country.
Canada1 site
DecisionLine Clinical Research Corporation
Toronto, Ontario, M5V 2T3
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Abuse Potential of Sativex in Subjects With a History of Recreational Marijuana Use
This crossover study with six treatment sessions is to evaluate the abuse potential of three doses of Sativex as compared to Marinol and placebo, in subjects with a history of recreational marijuana use.
Read the detailed description
Subjects attended a two-session, randomized, double-blind, crossover qualification in which they received the positive control drug (Marinol 30 mg) and matching placebo 48 hours apart in a randomized fashion. To qualify, subjects must have discriminated between Marinol and placebo.
Eligible subjects then went on to the main study divided into six treatment sessions each separated by 7-21 days.
Serial pharmacodynamic evaluations were taken at each treatment session as well as occasional pharmacokinetic blood samples to verify proof of exposure. In addition, safety monitoring included regular assessments of vital signs, telemetry, 12-lead ECG, clinical laboratory tests and adverse events (AEs).
- Conditions
- Evaluation of Abuse Potential of Sativex
- Being tested
- Sativex, Placebo, Marinol
- Keywords
- Sativex, Cannabinoids, Abuse potential, Addiction
- Medical subject headings
- Marijuana Abuse, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SativexDrug
Sativex dose level 1: 10.8 mg THC/10 mg CBD (4 sprays) + 12 placebo sprays + 4 placebo capsules.
SativexDrug
Sativex dose level 2: 21.6 mg THC/20 mg CBD (8 sprays) + 8 placebo sprays + 4 placebo capsules
SativexDrug
Sativex dose level 3: 43.2 mg THC/40 mg CBD (16 sprays) + 4 placebo capsules
PlaceboDrug
16 placebo sprays and 4 placebo capsules
MarinolDrug
Marinol dose level 1: 20 mg THC (2 marinol capsules) + 2 placebo capsules + 16 placebo sprays
MarinolDrug
Marinol dose level 2: 40 mg THC (4 marinol capsules) + 16 placebo sprays
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Sativex 4 sprays | Experimental | Not described Receives: Drug: Sativex |
| Sativex 8 sprays | Experimental | Not described Receives: Drug: Sativex |
| Sativex 16 sprays | Experimental | Not described Receives: Drug: Sativex |
| Marinol low dose | Active comparator | Not described Receives: Drug: Marinol |
| Marinol high dose | Active comparator | Not described Receives: Drug: Marinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Subjective Drug Value (SDV)(Balance of effects) between Marinol and Sativex
Mean difference in Mean peak effect (Emax) between:
Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg.
Measured: Recorded at 6, 12 and 24 hours during each study arm
Comparison of Bipolar Drug Liking VAS (Balance of effects) between Marinol and Sativex
Mean difference in Mean peak effect (Emax) between:
Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg.
Measured: Recorded at 12 and 24 hours during each study arm
Comparison of Addiction Research Centre Inventory (ARCI) MBG (Positive effects) between Marinol and Sativex
Mean difference in Mean peak effect (Emax) between:
Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg.
Measured: Recorded at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours during each study arm
Secondary outcomes (7)
Comparison of Balance of Effects VASs between Marinol and Sativex
Mean difference in Mean peak effect (Emax) between:
Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg. for each of Overall Drug Liking VAS, Take Drug Again VAS, Pleasant Mental state VAS, and Pleasant Physical state VAS.
Measured: Recorded at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study arm
Comparison of Positive Effects VASs between Marinol and Sativex
Mean difference in Mean peak effect (Emax) between:
Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg; for each of Good effects VAS and High VAS.
Measured: Recorded at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study arm
Comparison of Cannabinoid Effects between Marinol and Sativex
Mean difference in Mean peak effect (Emax) between:
Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg; for each of ARCI Marijuana, Stoned VAS, Mellow VAS, Clarity VAS, and Hungry VAS.
Measured: Recorded at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study arm
Comparison of Negative Effects Scores between Marinol and Sativex
Mean difference in Mean peak effect (Emax) between:
Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg; for each of ARCI Lysergic Acid Diethylamide, Bad Effects VAS, Nausea VAS, Feeling Sick VAS, and Room Spinning VAS.
Measured: Recordedat 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study arm
Comparison of Other Effects Scores between Marinol and Sativex
Mean difference in Mean peak effect (Emax) between:
Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg; for each of: Any effects VAS, Dizziness VAS, ARCI Pentobarbital-Chlorpromazine-Alcohol Group, Drowsiness VAS, ARCI Benzedrine Group, and ARCI Amphetamine, Drug similarity VASs, Choice Reaction Time, Divided Attention, Sternberg short-term memory tests.
Measured: Recorded pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study arm
Area under the concentration-time curve from 0 to 8.5 hours post-dose for plasma THC, CBD, and 11-hydroxy-THC.
Measured: Pre-dose and at 1, 4, and 8 hours during each study visit
Adverse Events
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Recorded pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startFeb 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Evaluation of Abuse Potential of SativexStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323569
- Sponsor's protocol ID
- GWCP0605
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2011
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Schoedel KA, Chen N, Hilliard A, White L, Stott C, Russo E, Wright S, Guy G, Romach MK, Sellers EM. A randomized, double-blind, placebo-controlled, crossover study to evaluate the subjective abuse potential and cognitive effects of nabiximols oromucosal spray in subjects with a history of recreational cannabis use. Hum Psychopharmacol. 2011 Apr;26(3):224-36. doi: 10.1002/hup.1196.
PubMed 21671456
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Abuse Potential of Sativex in Subjects With a History of Recreational Marijuana Use
- ClinicalTrials.gov ID
- NCT01323569
- Acronym / sponsor ID
- GWCP0605
- Conditions
- Evaluation of Abuse Potential of Sativex
- Keywords
- Sativex, Cannabinoids, Abuse potential, Addiction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 25 Mar 2011 (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.
This crossover study with six treatment sessions is to evaluate the abuse potential of three doses of Sativex as compared to Marinol and placebo, in subjects with a history of recreational marijuana use.
Detailed description
Subjects attended a two-session, randomized, double-blind, crossover qualification in which they received the positive control drug (Marinol 30 mg) and matching placebo 48 hours apart in a randomized fashion. To qualify, subjects must have discriminated between Marinol and placebo.
Eligible subjects then went on to the main study divided into six treatment sessions each separated by 7-21 days.
Serial pharmacodynamic evaluations were taken at each treatment session as well as occasional pharmacokinetic blood samples to verify proof of exposure. In addition, safety monitoring included regular assessments of vital signs, telemetry, 12-lead ECG, clinical laboratory tests and adverse events (AEs).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Sativex 4 sprays | Experimental | Drug: Sativex |
| Sativex 8 sprays | Experimental | Drug: Sativex |
| Sativex 16 sprays | Experimental | Drug: Sativex |
| Marinol low dose | Active comparator | Drug: Marinol |
| Marinol high dose | Active comparator | Drug: Marinol |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy male and female subjects, 19 to 45 years of age, inclusive.
- Current recreational marijuana users, defined as the use of smoked marijuana, hashish, or oral THC, at least once a week for the 3 months prior to screening and, on at least one occasion, four times in a given week in the 3 months prior to screening.
- Body mass index within the range of 19 to 30 kg/m2 inclusive and a minimum weight of at least 50 kg at screening.
- Free of any clinically significant abnormality, assessed at screening, on the basis of medical history, vital signs, physical examination, 12-lead ECG, and clinical laboratory tests, including haematology, clinical chemistry, urinalysis, and serology, as judged by the investigator or designee.
- A positive urine THC drug screen at screening and qualification, which was confirmed by quantitative analysis; the level must have been at least 50 ng of THC/mL.
Key exclusion criteria (15 listed)
- History or presence of drug or alcohol dependence (excluding nicotine and caffeine), including subjects who had ever been in a drug rehabilitation program.
- Clinically important impairment or dysfunction of any body system, including, but not limited to, the following: cardiovascular, haematological, hepatic, gastrointestinal, renal, pulmonary, or neurological, as judged by the investigator or designee.
- Any known or suspected history (including family history) of schizophrenia or other psychotic illness. Presence or history of a psychiatric disorder, organic brain disorder, or seizure disorder that was deemed clinically significant by the investigator.
- History of hypersensitivity or allergy to cannabinoids, cannabis and/or its metabolites, to the study drug excipients, or to similar compounds (propylene glycol, ethanol, peppermint, and sesame oils) or allergic reactions to any other medication.
- Consumed caffeine-containing beverages in excess of 450 mg of caffeine (e.g. 5 cups of tea or 3 cups of regular coffee or 8 cans of cola) per day in the 6 months prior to screening.
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 |
|---|---|---|
| SativexSativex dose level 1: 10.8 mg THC/10 mg CBD (4 sprays) + 12 placebo sprays + 4 placebo capsules. | Drug | Sativex 4 sprays |
| SativexSativex dose level 2: 21.6 mg THC/20 mg CBD (8 sprays) + 8 placebo sprays + 4 placebo capsules | Drug | Sativex 8 sprays |
| SativexSativex dose level 3: 43.2 mg THC/40 mg CBD (16 sprays) + 4 placebo capsules | Drug | Sativex 16 sprays |
| Placebo16 placebo sprays and 4 placebo capsules | Drug | Placebo |
| MarinolMarinol dose level 1: 20 mg THC (2 marinol capsules) + 2 placebo capsules + 16 placebo sprays | Drug | Marinol low dose |
| MarinolMarinol dose level 2: 40 mg THC (4 marinol capsules) + 16 placebo sprays | Drug | Marinol high dose |
Primary outcome
Comparison of Subjective Drug Value (SDV)(Balance of effects) between Marinol and Sativex
Time frame: Recorded at 6, 12 and 24 hours during each study arm
Mean difference in Mean peak effect (Emax) between: Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg.
Comparison of Bipolar Drug Liking VAS (Balance of effects) between Marinol and Sativex
Time frame: Recorded at 12 and 24 hours during each study arm
Mean difference in Mean peak effect (Emax) between: Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg.
Comparison of Addiction Research Centre Inventory (ARCI) MBG (Positive effects) between Marinol and Sativex
Time frame: Recorded at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours during each study arm
Mean difference in Mean peak effect (Emax) between: Marinol 20 mg vs Sativex 21.6 mg; Marinol 20 mg vs Sativex 43.2 mg; Marinol 40 mg vs Sativex 43.2 mg.
7 secondary outcomes
Comparison of Balance of Effects VASs between Marinol and Sativex
Time frame: Recorded at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study arm
Comparison of Positive Effects VASs between Marinol and Sativex
Time frame: Recorded at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study arm
Comparison of Cannabinoid Effects between Marinol and Sativex
Time frame: Recorded at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study arm
Comparison of Negative Effects Scores between Marinol and Sativex
Time frame: Recordedat 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study arm
Comparison of Other Effects Scores between Marinol and Sativex
Time frame: Recorded pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study arm
Area under the concentration-time curve from 0 to 8.5 hours post-dose for plasma THC, CBD, and 11-hydroxy-THC.
Time frame: Pre-dose and at 1, 4, and 8 hours during each study visit
Adverse Events
Time frame: Recorded pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours during each study visit
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 10 Apr 2023.
- Results publication: PubMed 21671456Schoedel KA, Chen N, Hilliard A, White L, Stott C, Russo E, Wright S, Guy G, Romach MK, Sellers EM. A randomized, double-blind, placebo-controlled, crossover study to evaluate the subjective abuse potential and cognitive effects of nabiximols oromucosal spray in subjects with a history of recreational cannabis use. Hum Psychopharmacol. 2011 Apr;26(3):224-36. doi: 10.1002/hup.1196.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sativex and Marinol in people with Evaluation of Abuse Potential of Sativex, run by Jazz Pharmaceuticals at 1 site in Canada.
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 12 inclusion and 15 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 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Comparison of Subjective Drug Value (SDV)(Balance of effects) between Marinol and Sativex (time frame: Recorded at 6, 12 and 24 hours during each study arm). The study lists 3 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 NCT01323569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.