Hemorrhoids Second DegreePhase 3NCT07909902
A Clinical Trial of Local Infiltration With Injection CZ1S for Postoperative Analgesia After Hemorrhoidectomy
A Phase 3 study testing CZ1S for injection, ropivacaine and Normal Saline (0.9% NaCl) in people with Hemorrhoids Second Degree and Hemorrhoids Third Degree, run by Zhejiang Cuize Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, active-controlled and placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of intravenous injection of CZ1S for local infiltration after hemorrhoidectomy in terms of pain relief. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemorrhoids Second Degree, Hemorrhoids Third Degree, Analgesia
- What is being tested?
- CZ1S for injection, ropivacaine and Normal Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2025to 11 Oct 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects can understand the procedures and methods of this clinical trial, have given full informed consent, and voluntarily participate and sign the informed consent form.
- Male or female individuals aged 18 to 65 years old; with a body mass index (BMI) within the range of [18.0 - 30.0] kg/m2 (including the critical value).
- Those who plan to undergo external dissection and internal ligation under general anesthesia.
- American Society of Anesthesiologists (ASA) classification levels I-II.
- The subjects must agree to take effective contraceptive measures from after signing the informed consent to 30 days after medication administration.
Who cannot join
- The subjects had pain unrelated to hemorrhoid diseases, and the researchers judged that it might confuse the postoperative assessors.
- Those who planned to undergo surgeries in other parts at the same time.
- Those with any of the following clinical severe disease histories or current severe diseases: ① respiratory system diseases ② neurological and mental disorders ③ circulatory system diseases ④ blood system diseases ⑤ tumors ⑥ digestive system diseases ⑥ having other diseases that might significantly affect the efficacy evaluation or in vivo metabolism of the test drug.
- Those who have undergone hemorrhoid resection surgery before.
- Those with fecal incontinence, perianal abscess, etc.
- Those with a history of constipation and the researchers judged that it might affect the postoperative pain assessment.
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- Those who had vomiting during the screening period or had a history of severe, refractory postoperative nausea and vomiting.
- Those who have obvious contraindications to the prescribed medication.
- Those with clinically significant laboratory test results during the screening period.
- Those with prolonged QTcF interval during the screening period: male ≥ 450 ms, female ≥ 470 ms.
- Those who are allergic to any component of the test drug, general anesthesia medication, rescue analgesic medication, antiemetic medication, or have a history of specific reactions.
- Those who used or were expected to use opioids, NSAIDs, sedative anesthetics, local anesthetics, glucocorticoids, anti-epileptic drugs, anti-anxiety drugs, anti-depressants, drugs with analgesic effect of traditional Chinese medicine/herbs, class III anti-arrhythmic drugs, strong CYP1A2 inhibitors, CYP1A2 highly sensitive substrates, strong CYP3A4 inhibitors, CYP3A4 highly sensitive substrates, strong CYP3A4 inducers within the first 5 half-lives of screening.
- Those who frequently drink alcohol within 3 months before screening (90 days), that is, those who consume more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol liquor or 150 mL of wine).
- Those who participated in clinical trials of drugs or devices within 3 months before screening and received treatment with the test drug or device.
- Those who have a history of drug abuse or drug use within the past 1 year.
- Those whose blood or urine pregnancy test is positive during the screening period, or are in lactation.
- Those who, in the researcher's opinion, cannot evaluate the efficacy or are unlikely to complete the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: A Multicenter, Randomized, Double-Blind, Active-Controlled and Placebo-Controlled Phase III Clinical Trial on the Efficacy and Safety of Intravenous CZ1S Local Infiltration for Postoperative Pain Relief Following Hemorrhoidectomy
This is a multicenter, randomized, double-blind, active-controlled and placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of intravenous injection of CZ1S for local infiltration after hemorrhoidectomy in terms of pain relief.
Read the detailed description
This study used the pain intensity score of the Numerical Rating Scale (NRS) as the indicator, and compared it with the saline solution. The efficacy of the injectable CZ1S for local infiltration in postoperative anal canal resection for pain relief was evaluated. The safety of the injectable CZ1S, the hydrochloric acid ropivacaine injection, and the saline solution for local infiltration in postoperative anal canal resection was also assessed and compared.
- Being tested
- CZ1S for injection, ropivacaine, Normal Saline (0.9% NaCl)
- Keywords
- Postoperative analgesia for hemorrhoids surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CZ1S for injectionDrug
intervention group
ropivacaineDrug
positive control
Normal Saline (0.9% NaCl)Drug
blank control
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine hydrochloride | Active comparator | 75mg (30mL) Receives: Drug: ropivacaine |
| normal saline | Placebo comparator | 30 mL Receives: Drug: Normal Saline (0.9% NaCl) |
| CZ1S for injection | Experimental | 600mg (30mL) Receives: Drug: CZ1S for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The NRS was used to assess the resting pain intensity score within 72 hours after administration. The area under the curve (AUC0-72h) of the resting pain intensity score for the test drug and the placebo control were compared.
Measured: 72 hours
The NRS was used to assess the resting pain intensity score within 48 hours after administration. The area under the curve (AUC0-48h) of the resting pain intensity score for the test drug and the hydrochloride ropivacaine injection were compared.
Measured: 48 hours
Secondary outcomes (2)
Compare the area under the time-curves of resting pain intensity scores for the test drug and the placebo control group from 0 to 24 hours and from 0 to 48 hours after administration.
Measured: from 0 to 24 hours and from 0 to 48 hours after administration.
Compare the area under the time-curves (AUC) of the resting pain intensity scores for the test drug and the hydrochloric acid ropivacaine injection from 0 to 24 hours and from 0 to 72 hours after administration.
Measured: from 0 to 24 hours and from 0 to 72 hours after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start21 May 2025
- Primary completion11 Oct 2025
- Study completion11 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhoids Second DegreeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cuize Pharmaceutical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909902
- Sponsor's protocol ID
- ZJCZ-CZ1S-041
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Active-Controlled and Placebo-Controlled Phase III Clinical Trial on the Efficacy and Safety of Intravenous CZ1S Local Infiltration for Postoperative Pain Relief Following Hemorrhoidectomy
- ClinicalTrials.gov ID
- NCT07909902
- Acronym / sponsor ID
- ZJCZ-CZ1S-041
- Keywords
- Postoperative analgesia for hemorrhoids surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Zhejiang Cuize Pharmaceutical Technology Co., Ltd.University, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 11 Oct 2025 (actual)
- Study completion
- 11 Oct 2025 (actual)
- First posted
- 2 Nov 2026 (actual)
- 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 is a multicenter, randomized, double-blind, active-controlled and placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of intravenous injection of CZ1S for local infiltration after hemorrhoidectomy in terms of pain relief.
Detailed description
This study used the pain intensity score of the Numerical Rating Scale (NRS) as the indicator, and compared it with the saline solution. The efficacy of the injectable CZ1S for local infiltration in postoperative anal canal resection for pain relief was evaluated. The safety of the injectable CZ1S, the hydrochloric acid ropivacaine injection, and the saline solution for local infiltration in postoperative anal canal resection was also assessed and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine hydrochloride | Active comparator | Drug: ropivacaine75mg (30mL) |
| normal saline | Placebo comparator | Drug: Normal Saline (0.9% NaCl)30 mL |
| CZ1S for injection | Experimental | Drug: CZ1S for injection600mg (30mL) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subjects can understand the procedures and methods of this clinical trial, have given full informed consent, and voluntarily participate and sign the informed consent form.
- Male or female individuals aged 18 to 65 years old; with a body mass index (BMI) within the range of [18.0 - 30.0] kg/m2 (including the critical value).
- Those who plan to undergo external dissection and internal ligation under general anesthesia.
- American Society of Anesthesiologists (ASA) classification levels I-II.
- The subjects must agree to take effective contraceptive measures from after signing the informed consent to 30 days after medication administration.
Key exclusion criteria (17 listed)
- The subjects had pain unrelated to hemorrhoid diseases, and the researchers judged that it might confuse the postoperative assessors.
- Those who planned to undergo surgeries in other parts at the same time.
- Those with any of the following clinical severe disease histories or current severe diseases: ① respiratory system diseases ② neurological and mental disorders ③ circulatory system diseases ④ blood system diseases ⑤ tumors ⑥ digestive system diseases ⑥ having other diseases that might significantly affect the efficacy evaluation or in vivo metabolism of the test drug.
- Those who have undergone hemorrhoid resection surgery before.
- Those with fecal incontinence, perianal abscess, 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 |
|---|---|---|
| CZ1S for injectionintervention group | Drug | CZ1S for injection |
| ropivacainepositive control | Drug | Ropivacaine hydrochloride |
| Normal Saline (0.9% NaCl)blank control | Drug | normal saline |
Primary outcome
The NRS was used to assess the resting pain intensity score within 72 hours after administration. The area under the curve (AUC0-72h) of the resting pain intensity score for the test drug and the placebo control were compared.
Time frame: 72 hours
The NRS was used to assess the resting pain intensity score within 48 hours after administration. The area under the curve (AUC0-48h) of the resting pain intensity score for the test drug and the hydrochloride ropivacaine injection were compared.
Time frame: 48 hours
2 secondary outcomes
Compare the area under the time-curves of resting pain intensity scores for the test drug and the placebo control group from 0 to 24 hours and from 0 to 48 hours after administration.
Time frame: from 0 to 24 hours and from 0 to 48 hours after administration.
Compare the area under the time-curves (AUC) of the resting pain intensity scores for the test drug and the hydrochloric acid ropivacaine injection from 0 to 24 hours and from 0 to 72 hours after administration.
Time frame: from 0 to 24 hours and from 0 to 72 hours after administration.
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 2 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Hemorrhoids Second Degree
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Traditional Medicine Syndromes in Internal Hemorrhoids: a Cross-Sectional Study
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CZ1S for injection, ropivacaine and Normal Saline (0.9% NaCl) in people with Hemorrhoids Second Degree and Hemorrhoids Third Degree, run by Zhejiang Cuize Pharmaceutical Technology Co., Ltd. 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 5 inclusion and 17 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 2 Nov 2026. 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 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?
The NRS was used to assess the resting pain intensity score within 72 hours after administration. The area under the curve (AUC0-72h) of the resting pain intensity score for the test drug and the placebo control were compared. (time frame: 72 hours). The study lists 2 primary outcomes in all. 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 2 Nov 2026.