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The purpose of this study is to assess the effectiveness, safety and pharmacokinetics of Oral Nalbuphine in the treatment of postoperative pain following hemorrhoidectomy.
• Primary Efficacy Endpoint: Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours.
• Secondary Efficacy Endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | Placebo soft capsules |
|
| Study group | Experimental | PHN131 soft capsule with Nalbuphine Hydrogen chloride (HCl) 60 mg/cap |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PHN131 soft capsule with Nalbuphine HCl 60 mg/cap | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Consumption of diclofenac dose | Consumption of diclofenac (Day 1-2) via Intramuscular Injection (IM injection) | in 48 hours after surgery |
| Time of operation to diclofenac dose | Time from the end of operation to the first IM injection diclofenac dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chang-Chieh Wu, MD | Tri-Service General Hospital (TSGH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Clinical Research Center, Tri-service General Hospital | Taipei | 114 | Taiwan |
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| ID | Term |
|---|---|
| D002214 | Capsules |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
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|
| Placebo soft capsules | Drug | Multiple dose of oral Placebo soft capsules, initial dose: 2 capsules, then 1 capsule; t.i.d. |
|
|
| Diclofenac | Drug | All subjects will receive diclofenac by IM injection for analgesia as rescue pain control. |
|
| in 48 hours after surgery |
| Brief Pain Inventory (BPI) | Brief Pain Inventory (BPI) | at 24h and 48h after surgery |
| Patient satisfaction | Patient satisfaction | at 48h after surgery |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |