aspirin has been researched along with Abdominal Pain in 45 studies
Aspirin: The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5)
acetylsalicylate : A benzoate that is the conjugate base of acetylsalicylic acid, arising from deprotonation of the carboxy group.
acetylsalicylic acid : A member of the class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group. A non-steroidal anti-inflammatory drug with cyclooxygenase inhibitor activity.
Abdominal Pain: Sensation of discomfort, distress, or agony in the abdominal region.
| Excerpt | Relevance | Reference |
|---|---|---|
| "This pooled analysis demonstrates a clear decrease in dyspepsia and an improvement in upper gastrointestinal tolerability for patients with osteoarthritis and rheumatoid arthritis taking valdecoxib, even at supratherapeutic doses, compared with those taking nonspecific nonsteroidal anti-inflammatory drugs over 12 weeks." | 8.82 | Meta-analysis: upper gastrointestinal tolerability of valdecoxib, a cyclooxygenase-2-specific inhibitor, compared with nonspecific nonsteroidal anti-inflammatory drugs among patients with osteoarthritis and rheumatoid arthritis. ( Eisen, GM; Goldstein, JL; Hanna, DB; Rublee, DA, 2005) |
| " The purpose of the present study was to examine 2 potential mitigation strategies for flushing and gastrointestinal (GI) events associated with DMF treatment: aspirin (ASA) 325 mg pretreatment for flushing, and slow dose titration of DMF for flushing and GI events." | 7.81 | Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate. ( Kurukulasuriya, NC; Li, J; O'Gorman, J; Phillips, G; Russell, HK; Viglietta, V, 2015) |
| " Additional studies are needed to assess the relationship between caffeine dosing and clinical benefits in patients with TTH and migraine." | 6.55 | Caffeine in the management of patients with headache. ( Diener, HC; Garas, SY; Lipton, RB; Patel, K; Robbins, MS, 2017) |
| "Kaempferol was shown to attenuate the expansion of inflammatory lesions seen in ethanol (EtOH)/HCl- and aspirin-induced gastritis, LPS/caerulein (CA) triggered pancreatitis, and acetic acid-induced writhing." | 5.42 | Kaempferol, a dietary flavonoid, ameliorates acute inflammatory and nociceptive symptoms in gastritis, pancreatitis, and abdominal pain. ( Baek, KS; Cho, JY; Ha, VT; Kim, E; Kim, HG; Kim, JH; Kim, SH; Lee, MN; Park, JG; Sung, GH; Sung, NY; Yang, S; Yang, WS; Yi, YS, 2015) |
| "This pooled analysis demonstrates a clear decrease in dyspepsia and an improvement in upper gastrointestinal tolerability for patients with osteoarthritis and rheumatoid arthritis taking valdecoxib, even at supratherapeutic doses, compared with those taking nonspecific nonsteroidal anti-inflammatory drugs over 12 weeks." | 4.82 | Meta-analysis: upper gastrointestinal tolerability of valdecoxib, a cyclooxygenase-2-specific inhibitor, compared with nonspecific nonsteroidal anti-inflammatory drugs among patients with osteoarthritis and rheumatoid arthritis. ( Eisen, GM; Goldstein, JL; Hanna, DB; Rublee, DA, 2005) |
| "The use of low-dose aspirin may aggravate the severity and mask the symptoms of abdominal pain in ischemic colitis." | 3.96 | Low-dose aspirin and the severity of ıschemic colitis: A single-center retrospective study. ( Deng, B; Ding, Y; Gong, W; Lu, G; Wang, Y; Wu, D; Wu, K; Xiao, W; Zhou, SY, 2020) |
| " The purpose of the present study was to examine 2 potential mitigation strategies for flushing and gastrointestinal (GI) events associated with DMF treatment: aspirin (ASA) 325 mg pretreatment for flushing, and slow dose titration of DMF for flushing and GI events." | 3.81 | Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate. ( Kurukulasuriya, NC; Li, J; O'Gorman, J; Phillips, G; Russell, HK; Viglietta, V, 2015) |
| " Gaultherin, 2-[(6-O-beta-D-Xylopyranosyl-beta-D-glucopyranosyl)oxy] benzoic acid methyl ester, a natural salicylate derivative extracted from Gaultheria yunnanensis, has been shown to have analgesic and anti-inflammatory effects and lack gastric ulcerogenic effect compared to aspirin in our primary study." | 3.73 | Gaultherin, a natural salicylate derivative from Gaultheria yunnanensis: towards a better non-steroidal anti-inflammatory drug. ( Ding, Y; Du, GH; He, XL; Zhang, B, 2006) |
| "One hundred one patients diagnosed with migraine (according to the International Headache Society diagnostic criteria) participated in the study." | 2.70 | Mouth-dispersible aspirin in the treatment of migraine: a placebo-controlled study. ( Davies, PT; Dowson, A; MacGregor, EA, 2002) |
| " The global incidence of adverse events was 45% higher with EC, though not significant (32 vs." | 2.69 | Comparative efficacy and safety of calcium carbasalate plus metoclopramide versus ergotamine tartrate plus caffeine in the treatment of acute migraine attacks. ( Geraud, G; Gómez, JP; Henry, P; Joffroy, A; Lainez, JM; Le Jeunne, C; Liaño, H; Pradalier, A; Titus i Albareda, F, 1999) |
| " Additional studies are needed to assess the relationship between caffeine dosing and clinical benefits in patients with TTH and migraine." | 2.55 | Caffeine in the management of patients with headache. ( Diener, HC; Garas, SY; Lipton, RB; Patel, K; Robbins, MS, 2017) |
| "Aspirin is a commonly used over-the-counter (OTC) agent for the symptomatic treatment of acute pain, fever, or the common cold, but data regarding safety in this context are limited." | 2.53 | Gastrointestinal Safety of Aspirin for a High-Dose, Multiple-Day Treatment Regimen: A Meta-Analysis of Three Randomized Controlled Trials. ( Forder, S; Lanas, A; Voelker, M, 2016) |
| "Aspirin was associated with a higher risk of minor gastrointestinal events than placebo or active comparators: the summary ORs were 1." | 2.49 | Gastrointestinal adverse effects of short-term aspirin use: a meta-analysis of published randomized controlled trials. ( Baron, JA; Brückner, A; Lanas, A; Laurora, I; McCarthy, D; Senn, S; Thielemann, W; Voelker, M, 2013) |
| "Infectious mononucleosis is a common viral illness of adolescence." | 2.48 | Spontaneous splenic rupture in infectious mononucleosis: case report and review of the literature. ( Pomerantz, WJ; Rinderknecht, AS, 2012) |
| "The risk of developing gastroduodenal ulcers or ulcer complications with the continued and long-term use of NSAIDs is now well recognised as an important problem commonly encountered in daily clinical practice." | 2.42 | Challenges in managing NSAID-associated gastrointestinal tract injury. ( Goldstein, JL, 2004) |
| "Acute renal infarction from thromboembolism is a rare but serious complication of arterial fibrillation." | 1.72 | A rare cause of abdominal pain managed unconventionally: acute renal infarction caused by atrial fibrillation: a case report. ( Ge, T; Song, EJ; Tang, S; Wang, J; Zhou, W; Zhu, Z, 2022) |
| "Kaempferol was shown to attenuate the expansion of inflammatory lesions seen in ethanol (EtOH)/HCl- and aspirin-induced gastritis, LPS/caerulein (CA) triggered pancreatitis, and acetic acid-induced writhing." | 1.42 | Kaempferol, a dietary flavonoid, ameliorates acute inflammatory and nociceptive symptoms in gastritis, pancreatitis, and abdominal pain. ( Baek, KS; Cho, JY; Ha, VT; Kim, E; Kim, HG; Kim, JH; Kim, SH; Lee, MN; Park, JG; Sung, GH; Sung, NY; Yang, S; Yang, WS; Yi, YS, 2015) |
| "We present a case of a child with heterotaxy syndrome who presented with spontaneous gastric perforation." | 1.36 | Spontaneous gastric perforation in a child with heterotaxy syndrome. ( Ellison, AM; Schinasi, DA, 2010) |
| "Macroamylasemia was demonstrated by precipitation of 99% amylase activity with polyethylene glycol 6000." | 1.33 | Macro-amylasemia in a patient with selective IgA deficiency and antiphospholipid antibodies. ( Ensari, A; Idilman, R; Ozden, A; Ozyüncü, N; Soylu, K; Türkçapar, N, 2006) |
| "Other signs typical of the Kawasaki disease occurred a few days later and permitted diagnosis." | 1.32 | Painful jaundice revealing Kawasaki disease in a young man. ( Disdier, P; Ene, N; Granel, B; Habib, G; Igual, JP; Serratrice, J; Weiller, PJ, 2004) |
| "Geraniin and furosin were about six- to seven-fold more potent at the ID50 level (micromol/kg) as analgesics than aspirin and acetaminophen, respectively, although they were less efficacious when compared with the standard drugs." | 1.29 | Chemical and preliminary analgesic evaluation of geraniin and furosin isolated from Phyllanthus sellowianus. ( Calixto, JB; Cechinel Filho, V; Ferrari, F; Messana, I; Miguel, OG; Pizzolatti, MG; Santos, AR; Yunes, RA, 1996) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 6 (13.33) | 18.2507 |
| 2000's | 18 (40.00) | 29.6817 |
| 2010's | 17 (37.78) | 24.3611 |
| 2020's | 4 (8.89) | 2.80 |
| Authors | Studies |
|---|---|
| Gökçe, M | 1 |
| Utku, S | 1 |
| Küpeli, E | 1 |
| Matsubara, S | 1 |
| Sada, KE | 1 |
| Sawada, H | 1 |
| Oida, J | 1 |
| Tanaka, K | 1 |
| Ge, T | 1 |
| Zhu, Z | 1 |
| Wang, J | 1 |
| Zhou, W | 1 |
| Song, EJ | 1 |
| Tang, S | 1 |
| Genç, S | 1 |
| Yeter, AS | 1 |
| Oğuz, AB | 1 |
| Koca, A | 1 |
| Polat, O | 1 |
| Günalp Eneyli, M | 1 |
| Xiao, W | 1 |
| Zhou, SY | 1 |
| Wu, K | 1 |
| Deng, B | 1 |
| Wu, D | 1 |
| Wang, Y | 1 |
| Gong, W | 1 |
| Ding, Y | 2 |
| Lu, G | 1 |
| Occhipinti, V | 1 |
| Segato, S | 1 |
| Carrara, A | 1 |
| Orlando, S | 1 |
| Conte, D | 1 |
| Lipton, RB | 1 |
| Diener, HC | 1 |
| Robbins, MS | 1 |
| Garas, SY | 1 |
| Patel, K | 1 |
| Patel, V | 1 |
| Ramachandran, B | 1 |
| Omar, I | 1 |
| Baron, JA | 1 |
| Senn, S | 1 |
| Voelker, M | 2 |
| Lanas, A | 2 |
| Laurora, I | 1 |
| Thielemann, W | 1 |
| Brückner, A | 1 |
| McCarthy, D | 1 |
| Dhaliwal, HS | 1 |
| Makkar, DS | 1 |
| Gowda, KK | 1 |
| Kim, SH | 1 |
| Park, JG | 1 |
| Sung, GH | 1 |
| Yang, S | 1 |
| Yang, WS | 1 |
| Kim, E | 1 |
| Kim, JH | 3 |
| Ha, VT | 1 |
| Kim, HG | 1 |
| Yi, YS | 1 |
| Baek, KS | 1 |
| Sung, NY | 1 |
| Lee, MN | 1 |
| Cho, JY | 1 |
| O'Gorman, J | 1 |
| Russell, HK | 1 |
| Li, J | 1 |
| Phillips, G | 1 |
| Kurukulasuriya, NC | 1 |
| Viglietta, V | 1 |
| Ahrens-Nicklas, RC | 1 |
| Edmondson, AC | 1 |
| Ficicioglu, C | 1 |
| Droppa, M | 1 |
| Karathanos, A | 1 |
| Gawaz, M | 1 |
| Geisler, T | 1 |
| Forder, S | 1 |
| Shimazu, Y | 1 |
| Fujimura, K | 1 |
| Edwards, A | 1 |
| Permar, S | 1 |
| Buck, S | 1 |
| Jhaveri, R | 1 |
| Endo, H | 1 |
| Hosono, K | 1 |
| Inamori, M | 1 |
| Nozaki, Y | 1 |
| Yoneda, K | 1 |
| Fujita, K | 1 |
| Takahashi, H | 1 |
| Yoneda, M | 1 |
| Abe, Y | 1 |
| Kirikoshi, H | 1 |
| Kobayashi, N | 1 |
| Kubota, K | 1 |
| Saito, S | 1 |
| Ohya, T | 1 |
| Hisatomi, K | 1 |
| Teratani, T | 1 |
| Matsuhashi, N | 1 |
| Nakajima, A | 1 |
| Schinasi, DA | 1 |
| Ellison, AM | 1 |
| Burri, E | 1 |
| Toia, D | 1 |
| Meier, R | 1 |
| Darshan, J | 1 |
| Shaw, E | 1 |
| Green, B | 1 |
| Gallagher, PJ | 1 |
| Gadola, SD | 1 |
| Baglikov, AN | 1 |
| Rafal'skiĭ, VV | 1 |
| Rinderknecht, AS | 1 |
| Pomerantz, WJ | 1 |
| Charachon, A | 1 |
| Petit, T | 1 |
| Lamarque, D | 1 |
| Soulé, JC | 1 |
| Goldstein, JL | 2 |
| Granel, B | 1 |
| Serratrice, J | 1 |
| Ene, N | 1 |
| Igual, JP | 1 |
| Habib, G | 1 |
| Disdier, P | 1 |
| Weiller, PJ | 1 |
| Eisen, GM | 1 |
| Hanna, DB | 1 |
| Rublee, DA | 1 |
| Yamamoto, K | 1 |
| Yasunaga, Y | 1 |
| Vogt, W | 1 |
| Zhang, B | 1 |
| He, XL | 1 |
| Du, GH | 1 |
| Otrock, ZK | 1 |
| Sawaya, JI | 1 |
| Zebian, RC | 1 |
| Taher, AT | 1 |
| Türkçapar, N | 1 |
| Ozyüncü, N | 1 |
| Idilman, R | 1 |
| Ensari, A | 1 |
| Soylu, K | 1 |
| Ozden, A | 1 |
| Scholbach, T | 1 |
| Woolard, JD | 1 |
| Ammar, AD | 1 |
| Perdreau, A | 1 |
| Reginster, P | 1 |
| Walz, B | 1 |
| Riecken, B | 1 |
| Tseng, GY | 1 |
| Lin, HJ | 1 |
| Malshe, PC | 1 |
| Miguel, OG | 1 |
| Calixto, JB | 2 |
| Santos, AR | 2 |
| Messana, I | 1 |
| Ferrari, F | 1 |
| Cechinel Filho, V | 2 |
| Pizzolatti, MG | 2 |
| Yunes, RA | 2 |
| de Campos, RO | 1 |
| Vaz, ZR | 1 |
| Pinheiro, TR | 1 |
| Delle Monache, F | 1 |
| Oshima, T | 1 |
| Le Jeunne, C | 1 |
| Gómez, JP | 1 |
| Pradalier, A | 1 |
| Titus i Albareda, F | 1 |
| Joffroy, A | 1 |
| Liaño, H | 1 |
| Henry, P | 1 |
| Lainez, JM | 1 |
| Geraud, G | 1 |
| Spitzer, MD | 1 |
| MacGregor, EA | 1 |
| Dowson, A | 1 |
| Davies, PT | 1 |
| Brazer, SR | 1 |
| Tyor, MP | 1 |
| Pancotto, FS | 1 |
| Nickl, NJ | 1 |
| Wildermann, NM | 1 |
| Harrell, FE | 1 |
| Pryor, DB | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Acute Headache Treatment in Pregnancy: Improvement in Pain Scores With Occipital Nerve Block vs PO Acetaminophen With Caffeine A Randomized Controlled Trial[NCT03951649] | Phase 4 | 62 participants (Actual) | Interventional | 2020-02-10 | Completed | ||
| A Randomized, Double-Blind, Phase 3b Study to Evaluate Effects of Aspirin or Dose Titration on Flushing and Gastrointestinal Events Following Oral Administration of BG00012 Dosed at 240 mg BID[NCT01568112] | Phase 3 | 173 participants (Actual) | Interventional | 2012-04-30 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
(NCT03951649)
Timeframe: 7 days
| Intervention | days (Median) |
|---|---|
| Occipital Nerve Block | 6 |
| Oral Acetaminophen/Caffeine Group | 1 |
(NCT03951649)
Timeframe: 28 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Occipital Nerve Block | 9 |
| Oral Acetaminophen/Caffeine Group | 4 |
(NCT03951649)
Timeframe: 7 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Occipital Nerve Block | 7 |
| Oral Acetaminophen/Caffeine Group | 2 |
Other: Pain at injection site (NCT03951649)
Timeframe: 7 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Occipital Nerve Block | 0 |
| Oral Acetaminophen/Caffeine Group | 2 |
(NCT03951649)
Timeframe: 7 hours
| Intervention | Participants (Count of Participants) |
|---|---|
| Occipital Nerve Block | 0 |
| Oral Acetaminophen/Caffeine Group | 0 |
(NCT03951649)
Timeframe: 4 hours
| Intervention | Participants (Count of Participants) |
|---|---|
| Occipital Nerve Block | 9 |
| Oral Acetaminophen/Caffeine Group | 14 |
(NCT03951649)
Timeframe: 5 hours
| Intervention | Participants (Count of Participants) |
|---|---|
| Occipital Nerve Block | 4 |
| Oral Acetaminophen/Caffeine Group | 2 |
Emergency department for treatment of headache since treatment asked at 28 day follow up (NCT03951649)
Timeframe: 28 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Occipital Nerve Block | 5 |
| Oral Acetaminophen/Caffeine Group | 1 |
(NCT03951649)
Timeframe: 120 min
| Intervention | Participants (Count of Participants) |
|---|---|
| Occipital Nerve Block | 5 |
| Oral Acetaminophen/Caffeine Group | 5 |
Based on guidelines from the International Headache Society the primary outcome is the portion of women who experience resolution of headache or improvement of headache to mild range (VRS ≤ 3) at 2 hours following treatment with Occipital nerve block as compared to acetaminophen/caffeine cocktail. (NCT03951649)
Timeframe: 60-300 min
| Intervention | Participants (Count of Participants) |
|---|---|
| Occipital Nerve Block | 20 |
| Oral Acetaminophen/Caffeine Group | 16 |
"Visual/verbal Rating Score (VRS). VRS is used to assess pain in patients. With 0 representing no pain at all and 10 representing worst possible pain.~Total Minimum score=0 Total Maximum score=10~Higher values represent worse pain. If VRS=0, then the headache pain is considered resolved." (NCT03951649)
Timeframe: 60 min
| Intervention | score on a scale (Median) |
|---|---|
| Occipital Nerve Block | 6 |
| Oral Acetaminophen/Caffeine Group | 3 |
"Visual/verbal Rating Score (VRS). VRS is used to assess pain in patients. With 0 representing no pain at all and 10 representing worst possible pain.~Total Minimum score=0 Total Maximum score=10~Higher values represent worse pain. If VRS=0, then the headache pain is considered resolved." (NCT03951649)
Timeframe: 180min
| Intervention | score on a scale (Median) |
|---|---|
| Occipital Nerve Block | 6 |
| Oral Acetaminophen/Caffeine Group | 4 |
"Visual/verbal Rating Score (VRS). VRS is used to assess pain in patients. With 0 representing no pain at all and 10 representing worst possible pain.~Total Minimum score=0 Total Maximum score=10~Higher values represent worse pain. If VRS=0, then the headache pain is considered resolved." (NCT03951649)
Timeframe: 2 hrs
| Intervention | score on a scale (Median) |
|---|---|
| Occipital Nerve Block | 6.0 |
| Oral Acetaminophen/Caffeine Group | 6.5 |
For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes. (NCT01568112)
Timeframe: Day 1 to Week 8
| Intervention | minutes (Mean) |
|---|---|
| Placebo | 98.4 |
| BG00012 | 63.2 |
| BG00012 + ASA | 69.8 |
| BG00012 Slow Titration | 68.9 |
For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes. (NCT01568112)
Timeframe: Week 1 to Week 4
| Intervention | minutes (Mean) |
|---|---|
| Placebo | 117.6 |
| BG00012 | 67.6 |
| BG00012 + ASA | 89.8 |
| BG00012 Slow Titration | 69.2 |
For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes. (NCT01568112)
Timeframe: Week 5 to Week 8
| Intervention | minutes (Mean) |
|---|---|
| Placebo | 113.2 |
| BG00012 | 55.7 |
| BG00012 + ASA | 73.2 |
| BG00012 Slow Titration | 56.0 |
The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence. (NCT01568112)
Timeframe: Day 1 to Week 8
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 73 |
| BG00012 | 81 |
| BG00012 + ASA | 81 |
| BG00012 Slow Titration | 86 |
The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration. (NCT01568112)
Timeframe: Day 1 to Week 8
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 59 |
| BG00012 | 70 |
| BG00012 + ASA | 79 |
| BG00012 Slow Titration | 79 |
The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration. (NCT01568112)
Timeframe: Week 1 to Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 57 |
| BG00012 | 65 |
| BG00012 + ASA | 67 |
| BG00012 Slow Titration | 71 |
The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence. (NCT01568112)
Timeframe: Day 1 to Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 66 |
| BG00012 | 81 |
| BG00012 + ASA | 79 |
| BG00012 Slow Titration | 79 |
The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration. (NCT01568112)
Timeframe: Week 5 to Week 8
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 34 |
| BG00012 | 59 |
| BG00012 + ASA | 50 |
| BG00012 Slow Titration | 58 |
The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence. (NCT01568112)
Timeframe: Week 5 to Week 8
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 41 |
| BG00012 | 59 |
| BG00012 + ASA | 53 |
| BG00012 Slow Titration | 61 |
Participant-reported flushing events during the overall treatment period, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1. (NCT01568112)
Timeframe: Day 2 to Week 8
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 43 |
| BG00012 | 86 |
| BG00012 + ASA | 74 |
| BG00012 Slow Titration | 93 |
Participant-reported flushing events during Weeks 1 to 4 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1. (NCT01568112)
Timeframe: Day 2 to Week 4
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 41 |
| BG00012 | 84 |
| BG00012 + ASA | 62 |
| BG00012 Slow Titration | 90 |
Participant-reported flushing events during Weeks 5 to 8 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score. (NCT01568112)
Timeframe: Week 5 to Week 8
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 24 |
| BG00012 | 86 |
| BG00012 + ASA | 67 |
| BG00012 Slow Titration | 85 |
Number of participants with clinical laboratory shifts from baseline in blood chemistry values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. ALP=alkaline phosphatase, ALT=alanine aminotransferase, AST=aspartate aminotransferase, GGT=gamma-glutamyl transferase, LDH=lactate dehydrogenase, BUN=blood urea nitrogen. (NCT01568112)
Timeframe: Day 1 to Week 8
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALP: shift to high; n=44, 42, 43, 42 | ALT: shift to high; n=44, 42, 43, 42 | AST: shift to high; n=44, 43, 43, 41 | GGT: shift to high; n=44, 41, 43, 42 | LDH: shift to low; n=44, 43, 43, 42 | LDH: shift to high; n=44, 43, 43, 42 | Total bilirubin: shift to high; n=44, 42, 42, 40 | BUN: shift to low; n=44, 43, 43, 42 | BUN: shift to high; n=44, 43, 41, 42 | Creatinine: shift to low; n=44, 43, 43, 42 | Creatinine: shift to high; n=44, 43, 43, 42 | Uric Acid: shift to low; n=44, 43, 43, 42 | Uric Acid: shift to high; n=44, 43, 43, 42 | Sodium: shift to low; n=44, 43, 43, 42 | Sodium: shift to high; n=44, 43, 43, 42 | Potassium: shift to low: n=44, 43, 43, 42 | Potassium: shift to high: n=44, 42, 42, 41 | Chloride: shift to low; n=44, 43, 43, 42 | Chloride: shift to high; n=44, 43, 43, 42 | Bicarbonate: shift to low; n=44, 43, 43, 42 | Bicarbonate: shift to high; n=44, 43, 43, 42 | Calcium: shift to low; n=44, 42, 43, 42 | Calcium: shift to high; n=44, 43, 43, 42 | Glucose: shift to low; n=43, 43, 41, 41 | Glucose: shift to high; n=44, 43, 43, 42 | Magnesium: shift to low; n=44, 43, 43, 42 | Magnesium: shift to high; n=44, 43, 43, 42 | Phosphorus: shift to low; n=44, 43, 43, 41 | Phosphorus: shift to high; n=44, 43, 43, 42 | Albumin: shift to low; n=44, 43, 43, 42 | Albumin: shift to high; n=44, 43, 43, 42 | Direct bilirubin: shift to high; n=44, 43, 43, 40 | Total protein: shift to low; n=44, 41, 43, 41 | Total protein: shift to high; n=44, 43, 43, 42 | |
| BG00012 | 0 | 2 | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| BG00012 + ASA | 0 | 5 | 4 | 2 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| BG00012 Slow Titration | 0 | 2 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Placebo | 0 | 1 | 2 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 3 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of participants with clinical laboratory shifts from baseline in hematology values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. abs=absolute (NCT01568112)
Timeframe: Day 1 to Week 8
| Intervention | participants (Number) | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| White blood cells: shift to low; n=43, 43, 43, 41 | White blood cells: shift to high; n=44, 43, 43, 42 | Neutrophils abs: shift to low; n=42, 42, 42, 41 | Neutrophils abs: shift to high; n=44, 43, 43, 42 | Lymphocytes abs: shift to low; n=43, 43, 43, 41 | Lymphocytes abs: shift to high; n=44, 43, 42, 42 | Monocytes abs: shift to low; n=44, 43, 43, 42 | Monocytes abs: shift to high; n=44, 43, 43, 42 | Eosinophils abs: shift to low; n=44, 43, 43, 42 | Eosinophils abs: shift to high; n=44, 43, 43, 42 | Basophils abs: shift to high; n=44, 43, 43, 42 | Red blood cells: shift to low; n=44, 43, 43, 40 | Red blood cells: shift to high; n=44, 43, 43, 42 | Hemoglobin: shift to low; n=43, 41, 43, 42 | Hemoglobin: shift to high; n=44, 43, 43, 42 | Hematocrit: shift to low; n=44, 43, 43, 42 | Hematocrit: shift to high; n=43, 43, 43, 42 | Platelets: shift to low; n=44, 43, 43, 42 | Platelets: shift to high; n=44, 41, 43, 42 | |
| BG00012 | 2 | 0 | 6 | 0 | 5 | 0 | 0 | 0 | 0 | 5 | 1 | 2 | 0 | 3 | 0 | 2 | 0 | 0 | 0 |
| BG00012 + ASA | 0 | 1 | 2 | 0 | 2 | 0 | 0 | 0 | 0 | 6 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| BG00012 Slow Titration | 0 | 0 | 2 | 1 | 3 | 0 | 0 | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Placebo | 0 | 0 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Number of participants with clinical laboratory shifts from baseline in urinalysis values.Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. Shift to positive includes negative to positive and unknown to positive. RBC=red blood cells, WBC=white blood cells. (NCT01568112)
Timeframe: Day 1 to Week 8
| Intervention | participants (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific gravity: shift to low; n=44, 43, 43, 42 | Specific gravity: shift to high; n=44, 42, 43, 42 | pH: shift to low; n=44, 43, 43, 42 | pH: shift to high; n=44, 43, 43, 42 | Blood: shift to positive; n=42, 39, 39, 42 | Color: shift to positive; n=41, 43, 41, 39 | Glucose: shift to positive; n=44, 43, 43, 41 | Ketones: shift to positive; n=44, 43, 43, 42 | Protein: shift to positive; n=44, 41, 43, 41 | Microscopic RBC; n=44, 40, 40, 41 | Microscopic WBC; n=43, 40, 41, 42 | |
| BG00012 | 0 | 0 | 0 | 0 | 6 | 1 | 2 | 7 | 1 | 4 | 9 |
| BG00012 + ASA | 0 | 2 | 0 | 0 | 1 | 4 | 1 | 9 | 1 | 1 | 3 |
| BG00012 Slow Titration | 0 | 0 | 0 | 0 | 2 | 5 | 0 | 6 | 1 | 2 | 3 |
| Placebo | 0 | 0 | 0 | 0 | 3 | 2 | 0 | 1 | 0 | 3 | 4 |
Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects. (NCT01568112)
Timeframe: Day 1 to Week 8
| Intervention | hours (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Nausea; n=12, 21, 21, 22 | Diarrhea; n=20, 20 17, 15 | Upper abdominal pain; n=17, 14, 19, 19 | Lower abdominal pain; n=12, 19, 17, 16 | Vomiting; n=3, 3, 3, 2 | Indigestion; n=12, 13, 12, 12 | Constipation; n=6, 8, 13, 11 | Bloating; n=14, 14, 21, 12 | Flatulence; n=23, 20, 22, 20 | |
| BG00012 | 7.05 | 2.92 | 6.67 | 13.93 | 10.08 | 16.49 | 28.20 | 16.91 | 9.06 |
| BG00012 + ASA | 10.01 | 14.66 | 15.88 | 10.84 | 1.88 | 3.80 | 14.26 | 9.68 | 68.93 |
| BG00012 Slow Titration | 2.98 | 4.97 | 3.83 | 7.75 | 0.75 | 4.91 | 20.90 | 77.24 | 63.84 |
| Placebo | 9.74 | 5.57 | 19.08 | 6.65 | 5.87 | 4.76 | 20.49 | 9.50 | 16.41 |
Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects. (NCT01568112)
Timeframe: Week 1 to Week 4
| Intervention | hours (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Nausea; n=10, 18, 18, 20 | Diarrhea; n=13, 20, 14, 14 | Upper abdominal pain; n=14, 14, 17, 15 | Lower abdominal pain; n=9, 18, 14, 13 | Vomiting; n=2, 2, 2, 2 | Indigestion; n=11, 11, 9, 11 | Constipation; n=4, 8, 11, 11 | Bloating; n=9, 14, 19, 11 | Flatulence; n=21, 17, 22, 19 | |
| BG00012 | 7.23 | 2.53 | 6.81 | 14.20 | 5.63 | 29.00 | 27.61 | 13.81 | 9.34 |
| BG00012 + ASA | 11.18 | 16.04 | 17.65 | 12.51 | 2.53 | 3.93 | 15.12 | 11.07 | 35.86 |
| BG00012 Slow Titration | 2.86 | 4.97 | 4.31 | 6.30 | 0.75 | 5.05 | 21.28 | 95.69 | 61.13 |
| Placebo | 10.47 | 5.20 | 21.37 | 5.40 | 4.31 | 5.08 | 17.05 | 6.70 | 12.83 |
Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects. (NCT01568112)
Timeframe: Week 5 to Week 8
| Intervention | hours (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Nausea; n=4, 9, 6, 9 | Diarrhea; n=12, 13, 6, 8 | Upper abdominal pain; n=6, 5, 5, 5 | Lower abdominal pain; n=7, 5, 5, 9 | Vomiting; n=1, 1, 1, 0 | Indigestion; n=6, 7, 7, 5 | Constipation; n=5, 2, 4, 4 | Bloating; n=7, 8, 7, 8 | Flatulence; n=9, 13, 7, 10 | |
| BG00012 | 4.34 | 6.62 | 1.12 | 3.98 | 19.00 | 2.57 | 15.47 | 18.52 | 7.21 |
| BG00012 + ASA | 2.66 | 7.05 | 1.86 | 2.84 | 0.58 | 5.02 | 21.30 | 4.16 | 105.86 |
| BG00012 Slow Titration | 2.34 | 2.14 | 1.73 | 22.54 | NA | 1.63 | 18.24 | 85.64 | 18.48 |
| Placebo | 3.96 | 4.50 | 5.29 | 6.63 | 9.00 | 2.43 | 23.35 | 12.49 | 44.67 |
↑=increase; ↓=decrease; BL=baseline; bpm=beats per minute; SBP=systolic blood pressure; DBP=diastolic blood pressure; b/m=breaths per minute (NCT01568112)
Timeframe: Day 1 to Week 8
| Intervention | participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Temperature >38°C + ↑ from BL of ≥1°C | Pulse >120 bpm or ↑ from BL of >20 bpm | Pulse <50 bpm or ↓ from BL of >20 bpm | SBP >180 mm Hg or ↑ from BL of >40 mm Hg | SBP <90 mm Hg or ↓ from BL of >30 mm Hg | DBP >105 mm Hg or ↑ from BL of >30 mm Hg | DBP <50 mm Hg or ↓ from BL of >20 mm Hg | Respiration rate >25 b/m or ↑ from BL of ≥50% | Respiration rate 10 b/m or ↓ from BL of ≥50% | |
| BG00012 | 0 | 10 | 4 | 0 | 2 | 0 | 3 | 2 | 0 |
| BG00012 + ASA | 0 | 20 | 3 | 0 | 1 | 0 | 0 | 3 | 0 |
| BG00012 Slow Titration | 0 | 17 | 4 | 0 | 1 | 0 | 1 | 3 | 0 |
| Placebo | 0 | 8 | 11 | 1 | 1 | 0 | 1 | 1 | 0 |
Shift to 'abnormal, not adverse event' includes unknown or normal to 'abnormal, not adverse event.' Shift to 'abnormal, adverse event' includes unknown or normal to 'abnormal, adverse event.' (NCT01568112)
Timeframe: Day 1 to Week 8
| Intervention | participants (Number) | |
|---|---|---|
| Shift to abnormal, not adverse event | Shift to abnormal, adverse event | |
| BG00012 | 3 | 0 |
| BG00012 + ASA | 2 | 0 |
| BG00012 Slow Titration | 4 | 0 |
| Placebo | 2 | 0 |
AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes. An AE was considered treatment-emergent if it occurred after the start of study treatment or was present prior to the start of study treatment but subsequently worsened. (NCT01568112)
Timeframe: Day 1 up to end of Safety Follow-up (9 weeks)
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Any event | Moderate or severe event | Severe event | Related event | Serious event | Discontinuation of treatment due to an event | Withdrawal from study due to an event | |
| BG00012 | 24 | 13 | 4 | 17 | 1 | 4 | 4 |
| BG00012 + ASA | 26 | 12 | 4 | 16 | 0 | 6 | 6 |
| BG00012 Slow Titration | 26 | 11 | 1 | 18 | 0 | 3 | 3 |
| Placebo | 24 | 10 | 0 | 8 | 0 | 2 | 2 |
Participant-reported flushing side effect events during the treatment period recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Day 1 to Week 8
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Overall flushing events | Overall redness events | Overall warmth events | Overall tingling events | Overall itching events | |
| BG00012 | 91 | 86 | 93 | 88 | 86 |
| BG00012 + ASA | 81 | 77 | 84 | 67 | 72 |
| BG00012 Slow Titration | 98 | 90 | 98 | 86 | 98 |
| Placebo | 41 | 27 | 41 | 23 | 20 |
Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Week 1 to Week 4
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Overall flushing events | Overall redness events | Overall warmth events | Overall tingling events | Overall itching events | |
| BG00012 | 86 | 81 | 88 | 84 | 77 |
| BG00012 + ASA | 72 | 63 | 67 | 51 | 56 |
| BG00012 Slow Titration | 98 | 88 | 95 | 83 | 95 |
| Placebo | 41 | 25 | 41 | 23 | 16 |
Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Week 5 to Week 8
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Overall flushing events | Overall redness events | Overall warmth events | Overall tingling events | Overall itching events | |
| BG00012 | 86 | 78 | 86 | 81 | 78 |
| BG00012 + ASA | 72 | 64 | 75 | 64 | 58 |
| BG00012 Slow Titration | 85 | 79 | 82 | 70 | 61 |
| Placebo | 24 | 15 | 17 | 15 | 22 |
Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. (NCT01568112)
Timeframe: Day 1 to Week 4
| Intervention | units on a scale (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Nausea | Diarrhea | Upper abdominal pain | Lower abdominal pain | Vomiting | Indigestion | Constipation | Bloating | Flatulence | |
| BG00012 | 1.6 | 1.8 | 1.1 | 1.4 | 0.3 | 0.9 | 0.9 | 1.1 | 1.3 |
| BG00012 + ASA | 1.6 | 1.5 | 1.7 | 1.3 | 0.3 | 0.6 | 0.6 | 1.3 | 1.4 |
| BG00012 Slow Titration | 1.5 | 1.0 | 1.4 | 1.2 | 0.2 | 0.9 | 0.9 | 1.0 | 1.6 |
| Placebo | 0.7 | 1.0 | 0.8 | 0.5 | 0.2 | 0.7 | 0.4 | 0.5 | 1.3 |
Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. (NCT01568112)
Timeframe: Week 5 to Week 8
| Intervention | units on a scale (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Nausea | Diarrhea | Upper abdominal pain | Lower abdominal pain | Vomiting | Indigestion | Constipation | Bloating | Flatulence | |
| BG00012 | 0.9 | 1.4 | 0.5 | 0.4 | 0.1 | 0.5 | 0.1 | 0.7 | 1.2 |
| BG00012 + ASA | 0.8 | 0.8 | 0.4 | 0.5 | 0.1 | 0.5 | 0.6 | 0.7 | 0.4 |
| BG00012 Slow Titration | 0.9 | 0.7 | 0.6 | 0.9 | 0.0 | 0.4 | 0.3 | 0.8 | 0.9 |
| Placebo | 0.4 | 1.0 | 0.6 | 0.6 | 0.2 | 0.4 | 0.4 | 0.5 | 0.8 |
Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Day 1 to Week 4
| Intervention | units on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Overall flushing | Redness | Warmth | Tingling | Itching | |
| BG00012 | 4.4 | 3.8 | 4.0 | 3.4 | 3.2 |
| BG00012 + ASA | 2.4 | 1.6 | 2.3 | 1.6 | 1.3 |
| BG00012 Slow Titration | 5.6 | 5.1 | 5.2 | 4.0 | 4.3 |
| Placebo | 1.2 | 0.7 | 1.2 | 0.5 | 0.5 |
Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). (NCT01568112)
Timeframe: Week 5 to Week 8
| Intervention | units on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Overall flushing | Redness | Warmth | Tingling | Itching | |
| BG00012 | 3.8 | 3.6 | 3.9 | 3.3 | 3.1 |
| BG00012 + ASA | 3.3 | 2.9 | 3.1 | 2.3 | 2.3 |
| BG00012 Slow Titration | 3.1 | 2.9 | 2.9 | 2.2 | 1.8 |
| Placebo | 0.9 | 0.4 | 0.8 | 0.3 | 0.7 |
8 reviews available for aspirin and Abdominal Pain
| Article | Year |
|---|---|
Caffeine in the management of patients with headache.
Topics: Abdominal Pain; Acetaminophen; Adult; Analgesics; Aspirin; Caffeine; Central Nervous System Stimulan | 2017 |
Gastrointestinal adverse effects of short-term aspirin use: a meta-analysis of published randomized controlled trials.
Topics: Abdominal Pain; Aspirin; Gastrointestinal Diseases; Humans; Randomized Controlled Trials as Topic; T | 2013 |
An 8-year-old girl with abdominal pain and mental status changes.
Topics: Abdominal Pain; Acute Disease; Ankle Injuries; Arthralgia; Aspirin; Child; Consciousness Disorders; | 2015 |
Gastrointestinal Safety of Aspirin for a High-Dose, Multiple-Day Treatment Regimen: A Meta-Analysis of Three Randomized Controlled Trials.
Topics: Abdominal Pain; Adolescent; Adult; Aged; Aged, 80 and over; Aspirin; Female; Gastrointestinal Diseas | 2016 |
Spontaneous splenic rupture in infectious mononucleosis: case report and review of the literature.
Topics: Abdominal Pain; Adolescent; Air Ambulances; Anti-Inflammatory Agents, Non-Steroidal; Anticoagulants; | 2012 |
Challenges in managing NSAID-associated gastrointestinal tract injury.
Topics: Abdominal Pain; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Cyclooxygenase Inhibitors; Digesti | 2004 |
Meta-analysis: upper gastrointestinal tolerability of valdecoxib, a cyclooxygenase-2-specific inhibitor, compared with nonspecific nonsteroidal anti-inflammatory drugs among patients with osteoarthritis and rheumatoid arthritis.
Topics: Abdominal Pain; Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumat | 2005 |
[Gastroenterology in the elderly].
Topics: Abdominal Pain; Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Anti-Inflammatory Agents, N | 2005 |
2 trials available for aspirin and Abdominal Pain
| Article | Year |
|---|---|
Comparative efficacy and safety of calcium carbasalate plus metoclopramide versus ergotamine tartrate plus caffeine in the treatment of acute migraine attacks.
Topics: Abdominal Pain; Adolescent; Adult; Aged; Analgesics; Aspirin; Caffeine; Double-Blind Method; Drug Th | 1999 |
Mouth-dispersible aspirin in the treatment of migraine: a placebo-controlled study.
Topics: Abdominal Pain; Administration, Oral; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; | 2002 |
35 other studies available for aspirin and Abdominal Pain
| Article | Year |
|---|---|
Synthesis and analgesic and anti-inflammatory activities 6-substituted-3(2H)-pyridazinone-2-acetyl-2-(p-substituted/nonsubstituted benzal)hydrazone derivatives.
Topics: Abdominal Pain; Analgesics; Animals; Anti-Inflammatory Agents, Non-Steroidal; Edema; Hydrazones; Inf | 2009 |
Small Intestinal Perforation Caused by Enteric-coated Low-dose Aspirin.
Topics: Abdominal Pain; Aged; Aspirin; Humans; Intestinal Perforation; Male; Proton Pump Inhibitors | 2023 |
A rare cause of abdominal pain managed unconventionally: acute renal infarction caused by atrial fibrillation: a case report.
Topics: Abdominal Pain; Aged; Anticoagulants; Aspirin; Atrial Fibrillation; Clopidogrel; Diltiazem; Humans; | 2022 |
Rectus Sheath Hematoma in a Patient with Dual-Antiplatelet Therapy Including Ticagrelor: A Case Report.
Topics: Abdominal Pain; Acute Coronary Syndrome; Aged, 80 and over; Aspirin; Hematoma; Humans; Male; Percuta | 2023 |
Low-dose aspirin and the severity of ıschemic colitis: A single-center retrospective study.
Topics: Abdominal Pain; Aged; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Colitis, Ischemic; Colon; Co | 2020 |
ERCP or NO ERCP: the case report of a frail patient.
Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Abdominal Pain; Aged; Angiotensin-Converting Enzyme Inhibit | 2018 |
Posterior reversible encephalopathy syndrome, preeclampsia or stroke? A diagnostic dilemma.
Topics: Abdominal Pain; Adrenergic beta-Antagonists; Aspirin; Diagnosis, Differential; Factor V; Female; Hea | 2019 |
A curious case of abdominal pain relieved by aspirin.
Topics: Abdominal Pain; Adult; Aspirin; Biopsy; Cyclooxygenase Inhibitors; Humans; Magnetic Resonance Imagin | 2014 |
Kaempferol, a dietary flavonoid, ameliorates acute inflammatory and nociceptive symptoms in gastritis, pancreatitis, and abdominal pain.
Topics: Abdominal Pain; Acetic Acid; Animals; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Ceruletide; | 2015 |
Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate.
Topics: Abdominal Pain; Adult; Aspirin; Constipation; Delayed-Action Preparations; Diarrhea; Dimethyl Fumara | 2015 |
Individualised dual antiplatelet therapy in a patient with short bowel syndrome after acute myocardial infarction with coronary artery stenting.
Topics: Abdominal Pain; Anterior Wall Myocardial Infarction; Aspirin; Clopidogrel; Cytochrome P-450 CYP2C19; | 2015 |
Acute pancreatitis as a side effect of anagrelide hydrochloride hydrate: a case report.
Topics: Abdominal Pain; Acute Disease; Aged; Aspirin; Drug Substitution; Female; Humans; Hydroxyurea; Janus | 2016 |
Ten-Year-Old Girl With Abdominal Pain, Irregular Breathing, and Tachycardia.
Topics: Abdominal Pain; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Cardiac Tam | 2017 |
Characteristics of small bowel injury in symptomatic chronic low-dose aspirin users: the experience of two medical centers in capsule endoscopy.
Topics: Abdominal Pain; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Ca | 2009 |
Spontaneous gastric perforation in a child with heterotaxy syndrome.
Topics: Abdominal Pain; Anticoagulants; Aspirin; Combined Modality Therapy; Cyanosis; Dextrocardia; Early Di | 2010 |
Triple pylorus.
Topics: Abdominal Pain; Aged; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Duodenal Diseases; Endoscopy | 2012 |
Intestinal ischaemia and mesenteric necrosis in a heavy smoker.
Topics: Abdominal Pain; Aspirin; Diarrhea; Humans; Jejunal Diseases; Male; Mesenteric Arteries; Middle Aged; | 2013 |
[The value of compliance during chronic administration of acetylsalicylic acid in patients with acute coronary syndrome: results of the study FORPOST].
Topics: Abdominal Pain; Acute Coronary Syndrome; Aged; Aspirin; Drug-Related Side Effects and Adverse Reacti | 2012 |
[Acute ulcerative colitis in a patient treated with rofecoxib who took aspirin as self-medication].
Topics: Abdominal Pain; Acute Disease; Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Aspirin; Biopsy; | 2003 |
Painful jaundice revealing Kawasaki disease in a young man.
Topics: Abdominal Pain; Adolescent; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Cholestasis; Humans; I | 2004 |
Antiplatelet therapy and spontaneous perirenal hematoma.
Topics: Abdominal Pain; Aged; Aspirin; Diagnosis, Differential; Follow-Up Studies; Hematoma; Humans; Ischemi | 2005 |
Gaultherin, a natural salicylate derivative from Gaultheria yunnanensis: towards a better non-steroidal anti-inflammatory drug.
Topics: Abdominal Pain; Acetic Acid; Administration, Oral; Animals; Anti-Inflammatory Agents, Non-Steroidal; | 2006 |
Spontaneous abdominal hematoma in a patient treated with clopidogrel and aspirin.
Topics: Abdominal Cavity; Abdominal Pain; Aged; Aspirin; Clopidogrel; Hematoma; Humans; Kidney Diseases; Mal | 2006 |
Macro-amylasemia in a patient with selective IgA deficiency and antiphospholipid antibodies.
Topics: Abdominal Pain; Adolescent; Amylases; Anti-Inflammatory Agents; Antibodies, Anticardiolipin; Aspirin | 2006 |
From the nutcracker-phenomenon of the left renal vein to the midline congestion syndrome as a cause of migraine, headache, back and abdominal pain and functional disorders of pelvic organs.
Topics: Abdominal Pain; Adolescent; Aspirin; Back Pain; Child; Child, Preschool; Constriction, Pathologic; D | 2007 |
Spontaneous dissection of the celiac artery: a case report.
Topics: Abdominal Pain; Analgesics, Opioid; Anticoagulants; Aortic Dissection; Aspirin; Celiac Artery; Diagn | 2007 |
[Clinical case of the month. Computerized tomographic diagnosis of hematoma of the rectus abdominis muscle].
Topics: Abdominal Pain; Aged, 80 and over; Aspirin; Cough; Diagnosis, Differential; Hematoma; Humans; Male; | 2007 |
[A young man with acute generalised jaundice and intermittent epigastric pain].
Topics: Abdominal Pain; Adult; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Diagnosis, Differential; Ge | 2008 |
Gastrointestinal symptoms in patients with end-stage renal disease undergoing treatment by hemodialysis or peritoneal dialysis.
Topics: Abdominal Pain; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Cross-Sectional Studies; Dyspepsia | 2008 |
What is this interaction?
Topics: Abdominal Pain; Aspirin; Carbonated Beverages; Humans; Nausea; Vomiting | 1994 |
Chemical and preliminary analgesic evaluation of geraniin and furosin isolated from Phyllanthus sellowianus.
Topics: Abdominal Pain; Acetaminophen; Acetates; Acetic Acid; Analgesics; Animals; Aspirin; Brazil; Glucosid | 1996 |
Antinociceptive properties of the hydroalcoholic extract and preliminary study of a xanthone isolated from Polygala cyparissias (Polygalaceae).
Topics: Abdominal Pain; Acetic Acid; Analgesia; Analgesics; Animals; Aspirin; Bradykinin; Capsaicin; Ethanol | 1997 |
[Predictive factors for development of hemolytic uremic syndrome (HUS) and early intensive treatments for prevention of HUS enterohemorrhagic Escherichia coli infection].
Topics: Abdominal Pain; Adolescent; Age Factors; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroi | 1997 |
Index of suspicion.
Topics: Abdominal Pain; Adolescent; Adrenal Hyperplasia, Congenital; Aspirin; Child, Preschool; Chlamydia In | 2001 |
Studies of gastric ulcer disease by community-based gastroenterologists.
Topics: Abdominal Pain; Alcohol Drinking; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Female; Gastroin | 1990 |