Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tramadol HCl, Tramadol Hydrochloride
Tramadol · 6 trials · 6 indications
The SPID is time-weighted sum of all observations of pain intensity difference (PID) collected at each measurement time point from Baseline to 48 hours. PID: Baseline pain intensity (PI) minus current PI; PI was assessed using 11-point numeric rating scale (NRS, 0=no pain to 10=worst pain imaginable). PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score \>=1 and \<=3, PI score of 2=NRS score of \>=4 and \<=6 and PI score of 3=NRS score of \>=7 and \<=10. Total score for SPID at 48 hours (SPID48) ranges from -144 (worst) to 144 (best).
The percentage of participants with extent of reduction in pain intensity greater than or equal to 30 percent was reported. Pain intensity change rate was calculated by Visual Analog Scale (VAS) score at baseline minus VAS score at Day 29 divided by VAS score at Baseline. VAS is a 10 centimeter (cm) scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.
Change in pain intensity experienced by participants over the last 48 hours was measured on Day 29 against Baseline with VAS. VAS is a 10 cm scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.
The pain relief was regarded as insufficient, if either of the following was met, a) the value of average pain intensity felt in daily living during the past 24 hours (Visual analog scale 24 \[VAS24\] ) on 2 consecutive days in double-blind period worsened greater than 15 millimeter (mm) compared with the average VAS24 during 3 days before the end of open-label period, b) when the participant asked for discontinuation of treatment with the study drug because of insufficient pain relief.
Pain over the last 24 hours was assessed by using VAS score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.
Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.
Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.
| Arm | Type | Description |
|---|---|---|
| Tramadol Hydrochloride/Acetaminophen ER | EXPERIMENTAL | Participants will be administered 2 oral tablets of extended release (ER) tramadol HCl (75 milligram \[mg\])/acetaminophen (650 mg) and 2 tablets of placebo matching to immediate release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matching to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours. |
| Tramadol HCl/Acetaminophen IR | ACTIVE_COMPARATOR | Participants will be administered 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matching to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours. |
| Tramadol Hydrochloride (HCl)/acetaminophen | EXPERIMENTAL | Participants will receive 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. |
| Placebo | PLACEBO_COMPARATOR | Prticipants will receive 1 tablet matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. |
| Tramadol Hydrochloride Plus Acetaminophen (Open-Label) | EXPERIMENTAL | - |
| Tramadol Hydrochloride Plus Acetaminophen (Double Blind) | EXPERIMENTAL | - |
| Placebo (Double-Blind) | PLACEBO_COMPARATOR | - |
| Tramadol HCL plus Acetaminophen | EXPERIMENTAL | - |
| Tramadol plus Acetaminophen and Placebo | EXPERIMENTAL | Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (\>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain). |
| Tramadol and Placebo | EXPERIMENTAL | Tramadol hydrochloride will be administered as single oral dosing of two capsules once at a dose of 75 milligram, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed \>= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain). |
| Acetaminophen and Placebo | EXPERIMENTAL | Acetaminophen will be administered as single oral dosing of two capsules once at a dose of 650 milligram, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed \>= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain). |
| Name | Type | Description |
|---|---|---|
| Tramadol HCl/Acetaminophen ER | DRUG | 2 tablets of ER (tramadol HCl \[75 mg\]/acetaminophen \[650 mg\]) will be administered at 0, 12, 24 and 36 hours |
| Tramadol HCl/Acetaminophen IR | DRUG | 2 tablets of IR (tramadol HCl \[37.5 mg\]/acetaminophen \[325 mg\]) at 0, 6, 12, 18, 24, 30, 36 and 42 hours |
| Tramadol HCl/acetaminophen Extended Release | DRUG | Participants will receive 1 tablet containing 75 mg of tramadol HCl and 650 mg of acetaminophen, once daily on Days 1to 3, then 1 tablet twice daily on Days 4 to 7 |
| Placebo | DRUG | Participants will receive 1 matching placebo tablet once daily on Days 1 to 3, then 1 tablet twice daily on Days 4 to 7 |
| Tramadol Hydrochloride Plus Acetaminophen (Open-Label) | DRUG | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily will be given for one week; dose level will be fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose will be 8 tablets). |
| Tramadol Hydrochloride Plus Acetaminophen (Double-Blind) | DRUG | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose \[number of tablets\] as that for the second week in the open-label period) will be given 4 times daily up to 4 weeks. |
| Placebo (Double-Blind) | DRUG | Matching placebo will be given up to 4 weeks. |
| Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013) | DRUG | Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets will be given orally four times daily (maximum dose is 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments will be established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval will be of at least 4 hours. |
| Tramadol Hydrochloride | DRUG | Tramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg). |
| Acetaminophen | DRUG | Acetaminophen two oral capsules will be administered once as 650 mg. |
| Tramadol plus Acetaminophen | DRUG | Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively. |
| tramadol, acetaminophen | DRUG | - |
Inclusion Criteria: * Participants who are scheduled to have standard primary (non-revision) unilateral (having to do with only 1 side of a structure) total knee replacement arthroplasty (TKRA-surgery to fix a joint) for non-inflammatory (no swelling, redness, and pain in tissues caused by injury o...
Top 4 of 15 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 4 | PHASE3 | Retatrutide, LY3016859, LY3556050, LY3526318, LY3857210 |
| Fortress Biotech, Inc. | FBIO | 1 | PHASE3 | Tramadol |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | MK-6916 |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | PHASE1 | CELZ-201-DDT |
Tramadol is used to treat pain, including chronic pain, postoperative pain, low back pain, and diabetic neuropathies. It is a small molecule pain therapy studied in both acute settings such as post-tooth-extraction pain and longer-term chronic pain populations. It is being developed by Johnson & Johnson under ticker JNJ.
Tramadol targets OPRM1, the mu-opioid receptor, and acts as an agonist at this receptor. This target class, opioid receptor agonism, is the basis for its analgesic activity in pain conditions. Tramadol is a small molecule agent in the pain therapeutic area.
Tramadol is developed by Johnson & Johnson, which trades under the ticker JNJ. The company has run Phase 3 studies of tramadol hydrochloride and tramadol plus acetaminophen formulations, including the extended release tramadol HCl/acetaminophen combination referred to as JNS013 in Japanese trials.
Tramadol is in Phase 3 clinical development. It is investigational, and the completed Phase 3 trials evaluated extended release tramadol hydrochloride/acetaminophen and tramadol plus acetaminophen formulations. No active trials are currently listed for this asset.
Tramadol has been studied in completed Phase 3 trials including NCT01814878 in moderate to severe postoperative pain, NCT01112267 in chronic low back pain, NCT00737048 in post-tooth-extraction pain in Japan, and NCT00736957 in Japanese participants with chronic pain. Total enrollment across these studies was 649 participants.
Yes. Tramadol is also known as tramadol hydrochloride or tramadol HCl, and the tramadol plus acetaminophen combination has been studied as JNS013. Other names include tramadol/acetaminophen, tramadol HCl/acetaminophen extended release, and the newly developed ULTRACET ER formulation.