DysmenorrheaPhase 3NCT01462370
Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1)
A Phase 3 study testing Etoricoxib, Ibuprofen and Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg in people with Dysmenorrhea, run by Organon and Co.
Trial summary
This is a study to determine the overall analgesic effect of a single oral dose of etoricoxib compared to ibuprofen in participants with moderate-to-severe primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Etoricoxib, Ibuprofen and Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Jun 2012
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agree to remain abstinent or use double-barrier contraception throughout the study. Participants who are status post tubal ligation are exempt from this requirement.
- Moderate or severe primary dysmenorrhea during a minimum of 4 of the previous 6 menstrual cycles. Moderate: Over-the-counter analgesics provide significant relief in most menstrual cycles; discomfort interferes with usual activity. Severe: Over-the-counter analgesics not consistently effective, or prescription analgesics required in at least some menstrual cycles; discomfort is incapacitating causing an inability to work or do usual activity.
- Willing to limit alcohol intake to 2 drinks or equivalent per day for the duration of the study and follow-up period as well as to avoid exercise during the first 24 hours postdose in each menstrual cycle.
- Able to read, understand, and complete diary.
Who cannot join
- Use of an intrauterine device. Pregnant, breast feeding, or <6 weeks postpartum.
- Active gastric ulcer or history of inflammatory bowel disease.
- Uncontrolled hypertension.
- Uncontrolled diabetes mellitus or renal disease.
- Class II-IV congestive heart failure.
- Coronary artery bypass graft surgery, angioplasty, myocardial infarction, cerebrovascular accident or transient ischemic attack within the past 6 months.
Show all 16Show fewer
- Unstable angina.
- Mild, moderate, or severe hepatic insufficiency.
- Any personal or family history of an inherited or acquired bleeding disorder.
- History of neoplastic disease; Exceptions: 1)adequately treated basal cell carcinoma or carcinoma in situ of the cervix; 2) other malignancies which have been successfully treated > or equal to 5 years prior to screening. Participants with a history of leukemia, lymphoma, malignant melanoma, and myeloproliferative disease are ineligible for the study regardless of the time since treatment.
- Allergic to etoricoxib, ibuprofen, acetaminophen, indomethacin, or other nonsteroidal anti-inflammatory drugs (NSAIDs), or cyclooxygenase (COX)-2 inhibitors, or to components in Saridon (propyphenazone/paracetamol/caffeine).
- Recent history of chronic analgesic or tranquilizer use or dependence.
- Morbidly obese and demonstrates significant health problems stemming from the obesity.
- Current user of recreational or illicit drugs or had a recent history of drug or alcohol abuse or dependence.
- Participated in another clinical study within the last 4 weeks.
- Not able to swallow oral medications: surgical or anatomical conditions that will preclude from swallowing and absorbing oral medications on an ongoing basis.
About this study
Official title: A Phase III, Randomized, Active-Comparator-Controlled, 2-period, Crossover, Double-Blind Study in China to Assess the Safety and Efficacy of Etoricoxib 120 mg Versus Ibuprofen up to 2400 mg (600 mg Q6h) in the Treatment of Patients With Primary Dysmenorrhea
This is a study to determine the overall analgesic effect of a single oral dose of etoricoxib compared to ibuprofen in participants with moderate-to-severe primary dysmenorrhea.
Read the detailed description
Participants who meet all the study entry criteria will be randomly allocated to 2 possible sequences of the 2 treatment regimens over the course of 2 menstrual cycles.
In treatment sequence 1, participants will receive etoricoxib 120 mg daily in menstrual cycle 1, and ibuprofen up to 2400 mg/daily in menstrual cycle 2. In treatment sequence 2, participants will receive ibuprofen up to 2400 mg/daily in menstrual cycle 1 and etoricoxib 120 mg daily in menstrual cycle 2.
- Conditions
- Dysmenorrhea
- Being tested
- Etoricoxib, Ibuprofen, Placebo to etoricoxib, Placebo to ibuprofen, Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoricoxibDrug
Etoricoxib 120 mg tablet given orally for one dose.
IbuprofenDrug
Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
Placebo to etoricoxibDrug
Placebo to etoricoxib, one tablet.
Placebo to ibuprofenDrug
Placebo to ibuprofen, up to four 3-capsule doses.
Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mgDrug
Also called Saridon
Provided to participants as rescue medication. Participants may take 2 tablets at a time and up to 3 doses within 24 hours for rescue purposes.
| Study group | Role | What they receive |
|---|---|---|
| Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen | Experimental | Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2. Receives: Drug: Etoricoxib; Drug: Ibuprofen; Drug: Placebo to etoricoxib; Drug: Placebo to ibuprofen; Drug: Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg |
| Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen | Experimental | Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2. Receives: Drug: Etoricoxib; Drug: Ibuprofen; Drug: Placebo to etoricoxib; Drug: Placebo to ibuprofen; Drug: Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose
TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24, with increasing scores indicating greater pain relief.
Measured: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours
Secondary outcomes (13)
Sum of Pain Intensity Difference Scores Over the 6-Hour Time Period (SPID6)
The Pain Intensity Difference (PID) score is the difference between the baseline pain intensity (PI) score and the PI score recorded at each time point post initial dose, as calculated by subtracting the pain intensity at each of the subsequent time points from the baseline pain intensity score; therefore, it is on a -1 to 3 scale, with a large value representing a greater treatment effect. SPID6 is derived by multiplying the PID score at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours and it is on a scale of -6 to 18.
Measured: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours
Mean Participant Global Evaluation of Pain at 6 Hours After the Initial Dose (GLOBAL6)
The GLOBAL6 was recorded by the participant at 6 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL6 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief.
Measured: 6 hours
Mean Participant Global Evaluation of Pain at 24 Hours After the Initial Dose (GLOBAL24)
The GLOBAL24 was recorded by the participant at 24 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL24 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief.
Measured: 24 hours
Mean Time to >=1 Unit Improvement From Baseline in Pain Intensity During the 6 Hours After the Initial Dose
The time to a change from baseline in pain intensity score of >=1 unit on the pain intensity scale was calculated. The pain intensity scale rates participant pain on a scale of -1 to 3, with larger values associated with greater treatment effect.
Measured: Baseline and 6 hours
Peak Pain Intensity Difference (PID) During the 6 Hours After the Initial Dose
Peak PID during the 6 hours post initial dose is defined as the maximum PID score recorded during first 6 hours after the initial dose of study medication. PID is evaluated on a scale of -1 to 3, with larger values representing a greater treatment effect.
Measured: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours
Peak Pain Relief (Peak PR) During the 6 Hours After the Initial Dose
Peak PR during the 6 hours post initial dose is defined as the maximum PR score
recorded during the first 6 hours after the initial dose of study medication. PR is recorded on a scale of 0 to 4, with 0 = no pain relief, 1 = little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.
Measured: Up to 6 hours
Number of Participants Using Rescue Medication 24 Hours After the Initial Dose
Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg (Saridon) was provided to each participant as rescue medication. Participants were permitted to take 2 tablets at a time and up to 3 doses within 24 hours of dosing of study drug for rescue purposes.
Measured: 24 Hours
PID at Up to 12 Hours Following the Initial Dose
PID during the 12 hours following the initial dose is defined as the maximum PID score recorded during first 12 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain.
Measured: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 and 12 hours
PR at Up to 12 Hours Following the Initial Dose
PR during the 12 hours following the initial dose is defined as the maximum PR score recorded during the first 12 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.
Measured: Up to 12 hours
PID at Up to 24 Hours Following the Initial Dose
PID during the 24 hours following the initial dose is defined as the maximum PID score recorded during first 24 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain.
Measured: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 20 and 24 hours
PR at Up to 24 Hours Following the Initial Dose
PR during the 24 hours following the initial dose is defined as the maximum PR score recorded during the first 24 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.
Measured: Up to 24 hours
Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 6 Hours After the Initial Dose
At 6 hours following the initial dose. participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 6 hours post initial dose were summed.
Measured: 6 hours
Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 24 Hours After the Initial Dose
At 24 hours following the initial dose of study medication, participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 24 hours post initial dose were summed.
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2012
- Study completionJun 2012
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 (1)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462370
- Sponsor's protocol ID
- 0663-145
- Status last verified
- Feb 2022
- First submitted
- 27 Oct 2011
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Yu Q, Zhu X, Zhang X, Zhang Y, Li X, Hua Q, Chang Q, Zou Q, Di W, Yao Y, Yu W, Liu J, Mehta A, Yan L. Etoricoxib in the treatment of primary dysmenorrhea in Chinese patients: a randomized controlled trial. Curr Med Res Opin. 2014 Sep;30(9):1863-70. doi: 10.1185/03007995.2014.925437. Epub 2014 Jun 30.
PubMed 24960147
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Active-Comparator-Controlled, 2-period, Crossover, Double-Blind Study in China to Assess the Safety and Efficacy of Etoricoxib 120 mg Versus Ibuprofen up to 2400 mg (600 mg Q6h) in the Treatment of Patients With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT01462370
- Acronym / sponsor ID
- 0663-145
- Conditions
- Dysmenorrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 31 Oct 2011 (estimated)
- Results
- Posted 10 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to determine the overall analgesic effect of a single oral dose of etoricoxib compared to ibuprofen in participants with moderate-to-severe primary dysmenorrhea.
Detailed description
Participants who meet all the study entry criteria will be randomly allocated to 2 possible sequences of the 2 treatment regimens over the course of 2 menstrual cycles.
In treatment sequence 1, participants will receive etoricoxib 120 mg daily in menstrual cycle 1, and ibuprofen up to 2400 mg/daily in menstrual cycle 2. In treatment sequence 2, participants will receive ibuprofen up to 2400 mg/daily in menstrual cycle 1 and etoricoxib 120 mg daily in menstrual cycle 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen | Experimental | Drug: Etoricoxib, Drug: Ibuprofen, Drug: Placebo to etoricoxib, Drug: Placebo to ibuprofen, Drug: Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mgParticipants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2. |
| Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen | Experimental | Drug: Etoricoxib, Drug: Ibuprofen, Drug: Placebo to etoricoxib, Drug: Placebo to ibuprofen, Drug: Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mgParticipants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Agree to remain abstinent or use double-barrier contraception throughout the study. Participants who are status post tubal ligation are exempt from this requirement.
- Moderate or severe primary dysmenorrhea during a minimum of 4 of the previous 6 menstrual cycles. Moderate: Over-the-counter analgesics provide significant relief in most menstrual cycles; discomfort interferes with usual activity. Severe: Over-the-counter analgesics not consistently effective, or prescription analgesics required in at least some menstrual cycles; discomfort is incapacitating causing an inability to work or do usual activity.
- Willing to limit alcohol intake to 2 drinks or equivalent per day for the duration of the study and follow-up period as well as to avoid exercise during the first 24 hours postdose in each menstrual cycle.
- Able to read, understand, and complete diary.
Key exclusion criteria (16 listed)
- Use of an intrauterine device. Pregnant, breast feeding, or <6 weeks postpartum.
- Active gastric ulcer or history of inflammatory bowel disease.
- Uncontrolled hypertension.
- Uncontrolled diabetes mellitus or renal disease.
- Class II-IV congestive heart failure.
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 |
|---|---|---|
| EtoricoxibEtoricoxib 120 mg tablet given orally for one dose. | Drug | Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen, Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen |
| IbuprofenIbuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day. | Drug | Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen, Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen |
| Placebo to etoricoxibPlacebo to etoricoxib, one tablet. | Drug | Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen, Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen |
| Placebo to ibuprofenPlacebo to ibuprofen, up to four 3-capsule doses. | Drug | Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen, Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen |
| Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mgAlso: SaridonProvided to participants as rescue medication. Participants may take 2 tablets at a time and up to 3 doses within 24 hours for rescue purposes. | Drug | Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen, Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen |
Primary outcome
Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose
Time frame: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours
TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24, with increasing scores indicating greater pain relief.
13 secondary outcomes
Sum of Pain Intensity Difference Scores Over the 6-Hour Time Period (SPID6)
Time frame: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours
Mean Participant Global Evaluation of Pain at 6 Hours After the Initial Dose (GLOBAL6)
Time frame: 6 hours
Mean Participant Global Evaluation of Pain at 24 Hours After the Initial Dose (GLOBAL24)
Time frame: 24 hours
Mean Time to >=1 Unit Improvement From Baseline in Pain Intensity During the 6 Hours After the Initial Dose
Time frame: Baseline and 6 hours
Peak Pain Intensity Difference (PID) During the 6 Hours After the Initial Dose
Time frame: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours
Peak Pain Relief (Peak PR) During the 6 Hours After the Initial Dose
Time frame: Up to 6 hours
Number of Participants Using Rescue Medication 24 Hours After the Initial Dose
Time frame: 24 Hours
PID at Up to 12 Hours Following the Initial Dose
Time frame: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 and 12 hours
PR at Up to 12 Hours Following the Initial Dose
Time frame: Up to 12 hours
PID at Up to 24 Hours Following the Initial Dose
Time frame: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 20 and 24 hours
PR at Up to 24 Hours Following the Initial Dose
Time frame: Up to 24 hours
Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 6 Hours After the Initial Dose
Time frame: 6 hours
Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 24 Hours After the Initial Dose
Time frame: 24 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24960147Yu Q, Zhu X, Zhang X, Zhang Y, Li X, Hua Q, Chang Q, Zou Q, Di W, Yao Y, Yu W, Liu J, Mehta A, Yan L. Etoricoxib in the treatment of primary dysmenorrhea in Chinese patients: a randomized controlled trial. Curr Med Res Opin. 2014 Sep;30(9):1863-70. doi: 10.1185/03007995.2014.925437. Epub 2014 Jun 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etoricoxib, Ibuprofen and Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg in people with Dysmenorrhea, run by Organon and Co.
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 4 inclusion and 16 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 10 Jul 2013). 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?
Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose (time frame: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours). 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 NCT01462370, 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 9 Feb 2022.