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| Name | Class |
|---|---|
| Cross S.A. | INDUSTRY |
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Two-part study of intrathecal paracetamol administered immediately before spinal anaesthesia in patients scheduled for hip replacement surgery
This is a prospective, single centre, two-part, three doses study. Part 1 is a Phase I, three cohorts, dose-ascending, open-label, safety study. Part 2 is a Phase II, randomised, parallel-group, double-blind, placebo-controlled, exploratory efficacy and safety study The objective of the study is to investigate the efficacy and safety of a single intrathecal injection of paracetamol, administered at 3 doses to 3 active treatment groups, as compared to placebo solution, for post-operative analgesia of hip replacement surgery performed under spinal anaesthesia. Patients scheduled for hip replacement surgery will be randomised into 4 treatment groups (15 patients per group) to receive either one of the 3 single doses of paracetamol 3% (D1: 60 mg, D2: 90 mg, D3: 120 mg) or placebo solution (P: saline solution) by intrathecal (IT) injection. Immediately after paracetamol or placebo IT administration, all patients will receive a single IT dose of Hyperbaric Bupivacaine HCl 0.5% (12.5 mg for ≤ 160 cm-tall patients and 15 mg for > 160 cm-tall patients). The time interval between paracetamol IT and bupivacaine IT administrations should not exceed 2 min.
The study will include a screening phase (Visit 1, Days -21/1), a treatment phase (paracetamol IT administration, anaesthesia and surgical procedure: Visit 2, Day 1) and a follow-up phase including an observation period (Visit 3, from Day 1 after surgery until discharge, a final visit (at discharge) and a follow-up (day 6±1). Pain at rest will be assessed at screening and on visit 2 at baseline (0 h), 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45 and 48 h after anaesthetic IT injection and at discharge, using a 0-100 mm VAS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 60 mg Paracetamol 3% (2 mL) | Experimental | 60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. |
|
| 90 mg Paracetamol 3% (3 mL) | Experimental | 90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. |
|
| 120 mg Paracetamol 3% (4mL) | Experimental | 120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. |
|
| Phase II Only: Saline solution 0.9% | Placebo Comparator | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol 3% | Drug | Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of Participants With Adverse Events Related, Not Related and Serious Events Related to Paracetamol | Phase 1: Number of participants with treatment evaluation and confirmation of the safety of the three doses of paracetamol 3% solution administered in the total number of patients enrolled | In the first 24 hours, in the first 48 hours and at day 7±1 |
| Phase 2: Pain Intensity | Phase 2: Pain intensity at rest evaluated as VAS scores ( 0-100 mm visual analogue scale : 0 is the absence pain and 100 is the maximum pain sensation) | baseline (0 h), 1, 6, 9, 12, 15, 24, and 48 h after anaesthetic IT injection and at discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Morphine | Phase 2: Total morphine use | At 24 and 48 h after anaesthetic IT injection and entire study period, up to 7 days |
| Phase 2: Time to First Morphine Use | Phase 2: Time to first morphine use (minutes) |
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Inclusion Criteria Phase 1 and Phase 2:
Exclusion Criteria Phase 1 and Phase 2:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Camponovo, MD | Department of Anaesthesiology,Clinica Ars Medica,Via Cantonale, CH-6929 Gravesano, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Claudio Camponovo | Gravesano | Lugano | CH-6929 | Switzerland |
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| ID | Title | Description |
|---|---|---|
| FG000 | 60 mg Paracetamol 3% (2 mL) | 60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Part |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2015 |
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4 arms for Phase II only
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Phase II only
| Placebo injection containing Saline solution 0.9% | Drug | Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. |
|
| Hyperbaric Bupivacaine HCl 0.5% | Drug | NIMP, spinal anaesthetic before the surgical procedure |
|
| Postoperative, up to 48 hours after end of surgery |
| Phase 2: Number of Participants With Need for Supplemental Analgesia | Phase 2: Need for supplementary analgesia, other than the planned morphine PCA | Postoperative, up to 48 hours after end of surgery |
| Phase 2: Morphine-related Adverse Events | Percentage of subjects experiencing during the study the morphine-related adverse events pre-specified in the protocol | up to 24 hours after surgery, up to 48 hours |
| Phase 2: Time to Readiness for Surgery | Time period from completion of spinal injection (time 0 h) to achievement of sensory and motor block adequate for surgery. | Intraoperative |
| Phase 2:Maximum Level of Sensory Block | Sensorial block will be verified by bilateral Pinprick test using a 20-G hypodermic needle and will be recorded. Pinprick sensation will be scored as being present (score 1) or absent (score 0). Onset of sensory block is defined as an absent touch sensation (score 0) | Intraoperative |
| Phase 2: Time to Sensory Block | Time to maximum level of sensory block | Intraoperative |
| Phase 2: Time to Regression of Spinal Block | Time period from spinal injection (time 0 h) to the time when the Bromage score returns to 0 and sensitive perception returns to S1. Bromage scale: I - Free movement of legs and feet II - Just able to flex knees with free movement of feet III - Unable to flex knees, but with free movement of feet IV - Unable to move legs or feet | from readiness for surgery,then every 10 min until the maximum level is reached (two consecutive observations with the same level of sensory block) and then every 30 min until regression of spinal block |
| Phase 2: Vital Signs | Systolic and Diastolic Blood Pressure (mmHg) | at screening, at baseline (before the spinal injection) and at end of the study (Day 6). |
| Phase2: Concomitant Medications | record the concomitant medications intaked during the study | at screening, at baseline until the end of the study (Day 6) |
| Phase 2: SpO2 | Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood. | at screening, at baseline (before the spinal injection) and at the end of the study (day 6) |
| Phase 2: ECG | Electrocardiography is the process of producing an electrocardiogram (ECG), it is a graph of voltage versus time of the electrical activity of the heart using electrodes placed on the skin. | screening, baseline and end of study (Day 6±1) |
| FG001 |
| 90 mg Paracetamol 3% (3 mL) |
90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
| FG002 | 120 mg Paracetamol 3% (4mL) | 120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
| FG003 | Phase II Only: Saline Solution 0.9% | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
| COMPLETED |
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| NOT COMPLETED |
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| Second Part |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 60 mg Paracetamol 3% (2 mL) | 60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
| BG001 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
| BG002 | 120 mg Paracetamol 3% (4mL) | 120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
| BG003 | Phase II Only: Saline Solution 0.9% | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1: Number of Participants With Adverse Events Related, Not Related and Serious Events Related to Paracetamol | Phase 1: Number of participants with treatment evaluation and confirmation of the safety of the three doses of paracetamol 3% solution administered in the total number of patients enrolled | Posted | Number | participants | In the first 24 hours, in the first 48 hours and at day 7±1 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Phase 2: Pain Intensity | Phase 2: Pain intensity at rest evaluated as VAS scores ( 0-100 mm visual analogue scale : 0 is the absence pain and 100 is the maximum pain sensation) | Posted | Mean | Standard Deviation | units on a scale | baseline (0 h), 1, 6, 9, 12, 15, 24, and 48 h after anaesthetic IT injection and at discharge |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Morphine | Phase 2: Total morphine use | Posted | Mean | Standard Deviation | mg | At 24 and 48 h after anaesthetic IT injection and entire study period, up to 7 days |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Time to First Morphine Use | Phase 2: Time to first morphine use (minutes) | Posted | Median | 95% Confidence Interval | minutes | Postoperative, up to 48 hours after end of surgery |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Number of Participants With Need for Supplemental Analgesia | Phase 2: Need for supplementary analgesia, other than the planned morphine PCA | Posted | Count of Participants | Participants | Postoperative, up to 48 hours after end of surgery |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Morphine-related Adverse Events | Percentage of subjects experiencing during the study the morphine-related adverse events pre-specified in the protocol | Posted | Count of Participants | Participants | up to 24 hours after surgery, up to 48 hours |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Time to Readiness for Surgery | Time period from completion of spinal injection (time 0 h) to achievement of sensory and motor block adequate for surgery. | Posted | Median | 95% Confidence Interval | minutes | Intraoperative |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2:Maximum Level of Sensory Block | Sensorial block will be verified by bilateral Pinprick test using a 20-G hypodermic needle and will be recorded. Pinprick sensation will be scored as being present (score 1) or absent (score 0). Onset of sensory block is defined as an absent touch sensation (score 0) | Posted | Number | participants | Intraoperative |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Time to Sensory Block | Time to maximum level of sensory block | Posted | Median | 95% Confidence Interval | minutes | Intraoperative |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Time to Regression of Spinal Block | Time period from spinal injection (time 0 h) to the time when the Bromage score returns to 0 and sensitive perception returns to S1. Bromage scale: I - Free movement of legs and feet II - Just able to flex knees with free movement of feet III - Unable to flex knees, but with free movement of feet IV - Unable to move legs or feet | Posted | Median | 95% Confidence Interval | minutes | from readiness for surgery,then every 10 min until the maximum level is reached (two consecutive observations with the same level of sensory block) and then every 30 min until regression of spinal block |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: Vital Signs | Systolic and Diastolic Blood Pressure (mmHg) | Posted | Mean | Standard Deviation | mmHg | at screening, at baseline (before the spinal injection) and at end of the study (Day 6). |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Phase2: Concomitant Medications | record the concomitant medications intaked during the study | Posted | Number | participants | at screening, at baseline until the end of the study (Day 6) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Phase 2: SpO2 | Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood. | Posted | Mean | Standard Deviation | Oxygen Saturation percentage | at screening, at baseline (before the spinal injection) and at the end of the study (day 6) |
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| Secondary | Phase 2: ECG | Electrocardiography is the process of producing an electrocardiogram (ECG), it is a graph of voltage versus time of the electrical activity of the heart using electrodes placed on the skin. | Posted | Count of Participants | Participants | screening, baseline and end of study (Day 6±1) |
|
Clinical study duration (7 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 60 mg Paracetamol 3% (2 mL) | 60 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure | 0 | 18 | 0 | 18 | 8 | 18 |
| EG001 | 90 mg Paracetamol 3% (3 mL) | 90 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure | 0 | 18 | 0 | 18 | 10 | 18 |
| EG002 | 120 mg Paracetamol 3% (4mL) | 120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure | 0 | 18 | 0 | 18 | 13 | 18 |
| EG003 | Phase II Only: Saline Solution 0.9% | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure | 0 | 15 | 0 | 15 | 11 | 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| procedural nausea | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| postprocedural constipation | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| urinary retention postoperative | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| procedural vomiting | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| joint dislocation | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| hypotension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
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| bradycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| atrial fibrillation | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| dyspespsia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| epigastric disconfrort | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| insomnia | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
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| prupritus | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| antiementic supportive care | Surgical and medical procedures | MedDRA 21.1 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Elisabetta Donati, Corporate Director Scientific Affairs | Sintetica SA | +41.91.640.42.50 | edonati@sintetica.com |
| May 4, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C063450 | 3-(cystein-S-yl)paracetamol |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Serious adverse event |
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| OG003 | Phase II Only: Saline Solution 0.9% | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
|
|
| OG003 | Phase II Only: Saline Solution 0.9% | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
|
|
| OG003 | Phase II Only: Saline Solution 0.9% | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
|
|
| OG003 | Phase II Only: Saline Solution 0.9% | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
|
|
| OG003 | Phase II Only: Saline Solution 0.9% | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
|
|
| OG003 | Phase II Only: Saline Solution 0.9% | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
|
|
| OG003 | Phase II Only: Saline Solution 0.9% | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
|
|
| OG003 | Phase II Only: Saline Solution 0.9% | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
|
|
| 120 mg Paracetamol 3% (4mL) |
120 mg Paracetamol 3%. Solution for injection, single administration by Intrathecal route. Paracetamol 3%: Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
| OG003 | Phase II Only: Saline Solution 0.9% | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
|
|
| OG003 | Phase II Only: Saline Solution 0.9% | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
|
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| OG003 | Phase II Only: Saline Solution 0.9% | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
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| OG003 | Phase II Only: Saline Solution 0.9% | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
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| OG003 | Phase II Only: Saline Solution 0.9% | Placebo, 0.9%. Solution for injection , single administration by route Intrathecal (2 mL, 3 mL and 4 mL) Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Placebo injection containing Saline solution 0.9%: Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list. Hyperbaric Bupivacaine HCl 0.5%: NIMP, spinal anaesthetic before the surgical procedure |
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| Abnormal, Not Clinically Significant |
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| Abnormal, Clinically Significant |
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| Abnormal, Not Clinically Significant |
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| Abnormal, Clinically Significant |
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