Analgesia DisorderPhase 2/3NCT02193620
Study of PHN131 in Patients After Surgery
A Phase 2/3 study testing PHN131 soft capsule with Nalbuphine HCl 60 mg/cap and Diclofenac in people with Analgesia Disorder, run by PhytoHealth Corporation at 1 site in Taiwan.
Trial summary
The purpose of this study is to assess the effectiveness, safety and pharmacokinetics of Oral Nalbuphine in the treatment of postoperative pain following hemorrhoidectomy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Analgesia Disorder
- What is being tested?
- PHN131 soft capsule with Nalbuphine HCl 60 mg/cap and Diclofenac
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Apr 2013to 13 Feb 2019
- Phase
- Phase 2/3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female >= 20 years of age at Screening
- Scheduled to electively undergo 2 or 3-column excisional hemorrhoidectomy
- American Society of Anesthesiology Physical Class 1 - 3
- Clinical lab values twice the upper limit of normal (values of potential clinical concern are detailed in Appendix) or, if abnormal, deemed not clinically significant per the Investigator.
- Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.
Who cannot join
- Body weight less than 40 kg.
- Concurrent fissurectomy.
- Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline.
- Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, Intrauterine Device (IUD), barrier device or abstinence) throughout the study.
- History of hypersensitivity or allergy to amide-type local anesthetics, opioid, or any ingredient of the medications administered in this study.
- Subject has a resting respiratory rate less than 8 per minute and blood oxygen saturation less than 90 mmHg.
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- Use of any NSAIDs, selective Cyclooxygenase-2 Inhibitors, opioid, acetaminophen, selective serotonin reuptake inhibitors (SSRI), tricyclic antidepressants (TCA), gabapentin, or pregabalin within three days of surgery.
- Chronic use of opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week.
- Use of any long-acting opioid medication within 3 days of surgery or any opioid medication within 24 hours of surgery.
- Current painful physical condition or concurrent surgery requires analgesic treatment in the postoperative period.
- Contraindication to epinephrine or any of the pain-control agents planned for postoperative use.
- Administration of an investigational drug within the longer of 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration.
- Any psychiatric disorder, psychological, medical, or laboratory condition that may interfere with study assessments or compliance.
- Significant medical conditions or laboratory results that may indicate an increased vulnerability to study drugs and procedures, and thus expose the subject to an unreasonable risk as a result of participating in this clinical trial.
- Any clinically significant event or condition uncovered during surgery.
- History of abuse illicit drugs, prescription medicines or alcohol within the past 2 years.
- Known history of anti-HIV antibody positive .
- Failure to pass drug and alcohol screen.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
General Clinical Research Center, Tri-service General Hospital
Taipei, 114
About this study
Official title: A Randomized, Double Blind, Placebo-controlled, Multiple Dose Study to Assess the Efficacy, Safety and Pharmacokinetics of Oral Nalbuphine, an Oral Soft Capsule, for Post-hemorrhoidectomy Pain Management
The purpose of this study is to assess the effectiveness, safety and pharmacokinetics of Oral Nalbuphine in the treatment of postoperative pain following hemorrhoidectomy.
Read the detailed description
- Primary Efficacy Endpoint: Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours.
- Secondary Efficacy Endpoints:
- Consumption of diclofenac (Day 1-2) via Intramuscular Injection (IM injection).
- Time from the end of operation to the first IM injection diclofenac dose
- Brief Pain Inventory (BPI).
- Patient satisfaction.
- Conditions
- Analgesia Disorder
- Being tested
- PHN131 soft capsule with Nalbuphine HCl 60 mg/cap, Placebo soft capsules, Diclofenac
- Keywords
- Analgesic, Narcotics, Opioids, Pain relief after surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHN131 soft capsule with Nalbuphine HCl 60 mg/capDrug
Also called PHN131
Multiple dose of oral PHN131 soft capsule with Nalbuphine HCl 60 mg/cap, initial dose : 120 mg ( 2 capsules), then 60 mg (1 capsule); t.i.d.
Placebo soft capsulesDrug
Also called Placebo
Multiple dose of oral Placebo soft capsules, initial dose: 2 capsules, then 1 capsule; t.i.d.
DiclofenacDrug
All subjects will receive diclofenac by IM injection for analgesia as rescue pain control.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Placebo soft capsules Receives: Drug: Placebo soft capsules; Drug: Diclofenac |
| Study group | Experimental | PHN131 soft capsule with Nalbuphine Hydrogen chloride (HCl) 60 mg/cap Receives: Drug: PHN131 soft capsule with Nalbuphine HCl 60 mg/cap; Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
the area under the curve of Visual Analogue Scale (VAS) pain intensity scores
Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours
Measured: at 1, 2, 3, 4±0.25, 8±0.5, 12±0.5, 16±0.5, 20±0.5, 24±1, 28±1, 32±2, 36±2, 40±2, 44±2, and 48±2 h after the surgery
Secondary outcomes (4)
Consumption of diclofenac dose
Consumption of diclofenac (Day 1-2) via Intramuscular Injection (IM injection)
Measured: in 48 hours after surgery
Time of operation to diclofenac dose
Time from the end of operation to the first IM injection diclofenac dose
Measured: in 48 hours after surgery
Brief Pain Inventory (BPI)
Brief Pain Inventory (BPI)
Measured: at 24h and 48h after surgery
Patient satisfaction
Patient satisfaction
Measured: at 48h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study start30 Apr 2013
- Primary completion21 Sep 2014
- Study completion13 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia DisorderStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhytoHealth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chang-Chieh Wu, MD, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193620
- Sponsor's protocol ID
- PH-CP025
- Status last verified
- Sep 2026
- First submitted
- 14 Jul 2014
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled, Multiple Dose Study to Assess the Efficacy, Safety and Pharmacokinetics of Oral Nalbuphine, an Oral Soft Capsule, for Post-hemorrhoidectomy Pain Management
- ClinicalTrials.gov ID
- NCT02193620
- Acronym / sponsor ID
- PH-CP025
- Conditions
- Analgesia Disorder
- Keywords
- Analgesic, Narcotics, Opioids, Pain relief after surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- PhytoHealth CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2013 (actual)
- Primary completion
- 21 Sep 2014 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 17 Jul 2014 (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 purpose of this study is to assess the effectiveness, safety and pharmacokinetics of Oral Nalbuphine in the treatment of postoperative pain following hemorrhoidectomy.
Detailed description
- Primary Efficacy Endpoint: Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours.
- Secondary Efficacy Endpoints:
- Consumption of diclofenac (Day 1-2) via Intramuscular Injection (IM injection).
- Time from the end of operation to the first IM injection diclofenac dose
- Brief Pain Inventory (BPI).
- Patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: Placebo soft capsules, Drug: DiclofenacPlacebo soft capsules |
| Study group | Experimental | Drug: PHN131 soft capsule with Nalbuphine HCl 60 mg/cap, Drug: DiclofenacPHN131 soft capsule with Nalbuphine Hydrogen chloride (HCl) 60 mg/cap |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female >= 20 years of age at Screening
- Scheduled to electively undergo 2 or 3-column excisional hemorrhoidectomy
- American Society of Anesthesiology Physical Class 1 - 3
- Clinical lab values twice the upper limit of normal (values of potential clinical concern are detailed in Appendix) or, if abnormal, deemed not clinically significant per the Investigator.
- Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.
Key exclusion criteria (18 listed)
- Body weight less than 40 kg.
- Concurrent fissurectomy.
- Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline.
- Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, Intrauterine Device (IUD), barrier device or abstinence) throughout the study.
- History of hypersensitivity or allergy to amide-type local anesthetics, opioid, or any ingredient of the medications administered in this study.
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 |
|---|---|---|
| PHN131 soft capsule with Nalbuphine HCl 60 mg/capAlso: PHN131Multiple dose of oral PHN131 soft capsule with Nalbuphine HCl 60 mg/cap, initial dose : 120 mg ( 2 capsules), then 60 mg (1 capsule); t.i.d. | Drug | Study group |
| Placebo soft capsulesAlso: PlaceboMultiple dose of oral Placebo soft capsules, initial dose: 2 capsules, then 1 capsule; t.i.d. | Drug | Placebo group |
| DiclofenacAll subjects will receive diclofenac by IM injection for analgesia as rescue pain control. | Drug | Placebo group, Study group |
Primary outcome
the area under the curve of Visual Analogue Scale (VAS) pain intensity scores
Time frame: at 1, 2, 3, 4±0.25, 8±0.5, 12±0.5, 16±0.5, 20±0.5, 24±1, 28±1, 32±2, 36±2, 40±2, 44±2, and 48±2 h after the surgery
Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours
4 secondary outcomes
Consumption of diclofenac dose
Time frame: in 48 hours after surgery
Time of operation to diclofenac dose
Time frame: in 48 hours after surgery
Brief Pain Inventory (BPI)
Time frame: at 24h and 48h after surgery
Patient satisfaction
Time frame: at 48h after surgery
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 18 Sep 2026.
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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.
Chang-Chieh Wu, MD principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PHN131 soft capsule with Nalbuphine HCl 60 mg/cap and Diclofenac in people with Analgesia Disorder, run by PhytoHealth Corporation at 1 site in Taiwan.
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 18 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 18 Sep 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 Taiwan. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 area under the curve of Visual Analogue Scale (VAS) pain intensity scores (time frame: at 1, 2, 3, 4±0.25, 8±0.5, 12±0.5, 16±0.5, 20±0.5, 24±1, 28±1, 32±2, 36±2, 40±2, 44±2, and 48±2 h after the surgery). 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 18 Sep 2026.