Postoperative PainPhase 4FAUCOPNCT00725218
Flurbiprofen Axetil for Uterine Contraction Pain
A Phase 4 study testing Saline and Flurbiprofen Axetil in people with Postoperative Pain, run by Nanjing Medical University at 1 site in China.
Trial summary
Uterine contraction pain is a common problem after abortion. Optimal analgesic for such suffering is still needed to be guaranteed. Flurbiprofen Axetil is a target-distributable non-steroidal anti-inflammatory drug (NSAID) functioning via block the synthesis of prostaglandin E (PGE). Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Saline and Flurbiprofen Axetil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteChina
- Study dates
- May 2008to Aug 2008
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA status I-II
- Performing abortion operation (medical- or drug-induced
- Requiring painless abortion
Who cannot join
- < 19yrs, and >= 45yrs
- History of central active drugs administration
- Drug abuse
- Hypertension
- Diabetes
- Any other chronic diseases
Show all 10Show fewer
- Allergy to the study drugs
- Habit of over-volume alcohol drinking
- Records of history of centrally active drug use and psychiatry
- Any organic disorders
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Phase IV Study of Flurbiprofen Axetil for Uterine Contraction Pain After Abortion
Uterine contraction pain is a common problem after abortion. Optimal analgesic for such suffering is still needed to be guaranteed. Flurbiprofen Axetil is a target-distributable non-steroidal anti-inflammatory drug (NSAID) functioning via block the synthesis of prostaglandin E (PGE). The investigators hypothesized that Flurbiprofen Axetil could suppress the uterine contraction pain after abortion effectively.
- Conditions
- Postoperative Pain
- Being tested
- Saline, Flurbiprofen Axetil
- Keywords
- NSAIDs, Postoperative pain, Analgesia, Abortion
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Also called Ringer's solution
Saline 5 ml injection 10 min prior to propofol administration.
Flurbiprofen AxetilDrug
Also called KaiFen
Flurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Saline 5 ml injection 10 min prior to propofol administration. Receives: Drug: Saline |
| 2 | Experimental | Flurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration. Receives: Drug: Flurbiprofen Axetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain scorings
Measured: At the end of the operation, 0,5,15,30,60min after operation
Secondary outcomes (4)
Anesthetic consumptions
Measured: At the end of the operation
Overall VAS satisfaction scorings with analgesia
Measured: At the end of the study
Side effects
Measured: During the whole period of the study
Volume of bleeding
Measured: At the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725218
- Sponsor's protocol ID
- NMU-MZ203
- Other IDs
- M089732
- Acronym
- FAUCOP
- Status last verified
- May 2008
- First submitted
- 28 Jul 2008
- Last updated
- 6 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Flurbiprofen Axetil for Uterine Contraction Pain After Abortion
- ClinicalTrials.gov ID
- NCT00725218
- Acronym / sponsor ID
- FAUCOP / NMU-MZ203
- Conditions
- Postoperative Pain
- Keywords
- NSAIDs, Postoperative pain, Analgesia, Abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 30 Jul 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.
Uterine contraction pain is a common problem after abortion. Optimal analgesic for such suffering is still needed to be guaranteed. Flurbiprofen Axetil is a target-distributable non-steroidal anti-inflammatory drug (NSAID) functioning via block the synthesis of prostaglandin E (PGE). The investigators hypothesized that Flurbiprofen Axetil could suppress the uterine contraction pain after abortion effectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: SalineSaline 5 ml injection 10 min prior to propofol administration. |
| 2 | Experimental | Drug: Flurbiprofen AxetilFlurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA status I-II
- Performing abortion operation (medical- or drug-induced
- Requiring painless abortion
Key exclusion criteria (10 listed)
- < 19yrs, and >= 45yrs
- History of central active drugs administration
- Drug abuse
- Hypertension
- Diabetes
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 |
|---|---|---|
| SalineAlso: Ringer's solutionSaline 5 ml injection 10 min prior to propofol administration. | Drug | 1 |
| Flurbiprofen AxetilAlso: KaiFenFlurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration. | Drug | 2 |
Primary outcome
VAS pain scorings
Time frame: At the end of the operation, 0,5,15,30,60min after operation
4 secondary outcomes
Anesthetic consumptions
Time frame: At the end of the operation
Overall VAS satisfaction scorings with analgesia
Time frame: At the end of the study
Side effects
Time frame: During the whole period of the study
Volume of bleeding
Time frame: At the end of the study
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 6 Aug 2008.
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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.
XiaoFeng Shen, MD study director
Nanjing Medical University
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 Saline and Flurbiprofen Axetil in people with Postoperative Pain, run by Nanjing Medical University at 1 site in China.
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 3 inclusion and 10 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 6 Aug 2008. 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 China. 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?
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?
VAS pain scorings (time frame: At the end of the operation, 0,5,15,30,60min after operation). 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 6 Aug 2008.