Arzneimittel Forsch
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Arzneimittel Forsch · Jan 2004
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialClinical, double-blind, placebo-controlled study investigating the combination of acetylsalicylic acid and pseudoephedrine for the symptomatic treatment of nasal congestion associated with common cold.
It was the aim of this clinical study to demonstrate the efficacy of 1000 mg acetylsalicylic acid (ASA, CAS 50-78-2) in combination with 60 mg pseudoephedrine (PSE, CAS 90-82-4), compared with placebo, in the symptomatic treatment of nasal congestion associated with the common cold. A further aim was to demonstrate the efficacy of 500 mg ASA + 30 mg PSE and of 1000 mg paracetamol (CAS 103-90-2) + 60 mg PSE (active control) in the symptomatic treatment of nasal congestion. The study was designed as a randomized, two-center, double-blind, double-dummy, placebo-controlled, parallel-group, single-dose efficacy and safety trial over 6 h and was carried out in the USA. ⋯ The treatment proved to be safe and well tolerated, without relevant differences between the four treatment groups. Main adverse events were found to be related to the upper respiratory tract infection or were of gastrointestinal nature. In conclusion, the combination of ASA with PSE can be considered as an effective and safe remedial for the symptomatic treatment of the nasal congestion during URTI.
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Arzneimittel Forsch · Jan 2004
Randomized Controlled Trial Clinical TrialEffect of the new H1-antagonist ReN1869 on capsaicin-induced hyperalgesia in human skin/Human phase-I trial using somatosensory evoked potentials induced by a CO2 laser.
Extensive pre-clinical investigations have shown that the tricyclic compound ReN1869 ((R)-1-(3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-1-propyl)-3-piperidine carboxylic acid, CAS 170149-99-2) is a potent H1-antagonist with pronounced antinociceptive properties. In this human phase-I trial the effect of different acute and multiple doses of ReN1869 on capsaicin induced neurogenic inflammation and hyperalgesia was investigated. Twenty-one healthy male subjects were enrolled in this randomised, double-blind, three-period, crossover trial design--consisting of acute and one week b.i.d. oral administration of 25 and 50 mg doses of ReN1869 and matching placebo--separated by 3 week washout periods. ⋯ This suppression was dose-dependent and was more pronounced after a one week treatment (subchronic mode) with ReN1869 than after the first dose (acute mode). In contrast to the (central) P2-component there was no significant effect on the (peripheral) N1-component of the LSEPs taken from capsaicin-treated skin. As ReN1869 had no significant effect when the laser pulses were applied to normal skin, and the compound's effect was mainly restricted to the (central) P2-component, when LSEPs were taken from capsaicin treated skin, it can be concluded that ReN1869 exerts its positive effect to reduce capsaicin-induced hyperalgesia by a primarily central mechanism.
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Arzneimittel Forsch · Jan 2004
Randomized Controlled Trial Clinical TrialDissociation of morphine analgesia and sedation evaluated by EEG measures in healthy volunteers.
The analgesic effects of morphine (CAS 57-27-2) in clinical use are well described. Sedation is discussed as a relevant side-effect, mostly based on data recorded in normal subjects without pain. The aim of this study was to quantify and to evaluate electrophysiologically the analgesic and sedative effects of morphine for the first time using an experimental pain model. ⋯ The lack of sedative effects in the presence of marked analgesia was surprising in comparison with results of previous studies. It is concluded that the experimental pain increased the arousal level thus counteracting morphine-induced sedation. This may explain why other studies found relevant sedation after morphine application in the absence of pain. This underlines that sedative effects of analgesic drugs should be evaluated in the presence of pain. In relation to other analgesics (meperidine, pentacozine, nortilidine, flupirtine and tramadol) evaluated by exactly the same experimental protocol, morphine exhibited a potent analgesia with the smallest sedative effects of all.
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Arzneimittel Forsch · Jan 2004
Randomized Controlled Trial Comparative Study Clinical TrialComparison of two different preparations of ibuprofen with regard to the time course of their analgesic effect. A randomised, placebo-controlled, double-blind cross-over study using laser somatosensory evoked potentials obtained from UW-irritated skin in healthy volunteers.
In the treatment of painful conditions the time to onset of a drug's analgesic effect is of great relevance. Plain ibuprofen acid (Ibu, CAS 15687-27-1) is relatively slowly absorbed after oral administration (t(max) is about 90-120 min). If, however, ibuprofen is given in form of a lysine salt, absorption is much quicker. ⋯ The reduction of the amplitudes of the single N1-components by IbuLys was significant in comparison to Plc (p < or = 0.0031), but not in comparison to Ibu. During the time of 5 h after medication the attenuating (analgesic) effect of IbuLys on the amplitude of the P2 component of the LSEPs was stronger than that of Plc (p < or = 0.0053) and stronger than that of Ibu (p < or = 0.0058). In summary IbuLys was significantly superior to Ibu with respect to the onset and extent of the analgesic effect. drugs were used to measure the extent of the analgesic effects. superior to Ibu with respect to the onset and extent of the analgesic effect.
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Arzneimittel Forsch · Jan 2004
Randomized Controlled Trial Clinical TrialAnalgesic effects of low-dose intravenous orphenadrine in the state of capsaicin hyperalgesia. A randomised, placebo-controlled, double-blind cross-over study using laser somatosensory evoked potentials obtained from capsaicin-irritated skin in healthy volunteers.
The present investigation aimed to elucidate the analgesic efficacy of 30 mg of intravenous orphenadrine citrate (CAS 4682-36-4) in a human pain model. Eighteen healthy female and male subjects were enrolled and received single infusions of 30 mg orphenadrine citrate and matching placebo in two periods which were separated by a 1 week washout period. The study was designed as a randomised, double-blind, placebo-controlled, two-period, cross-over trial. ⋯ The effect on the central component was highly significant and more pronounced than the peripheral effect of the drug. The analgesic effect developed fast, was already present during infusion, was ongoing, and exceeded the observational period of 4 h after start of infusion. In summary, orphenadrine citrate was able to exert an analgesic/anti-hyperalgesic effect in a low-dose paradigm (30 mg dose) which was predominantly due to central/spinal mechanisms in this capsaicin model with laser somatosensory evoked potentials.